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# FDAPulse: all 764 record reports, page 1 of 4

Every FDAPulse record report, 200 per page, grouped by state. Records 1 to 200: Class II recall Z-0186-2027: INTELERAD MEDICAL SYSTEMS INCORPORATED to Hemostatic Clip (K261741): 510(k) cleared for Anrei Medical (Hz) Co., Ltd.. Source: U.S. FDA openFDA.

1 [2](/hub/fdapulse/records/2) [3](/hub/fdapulse/records/3) [4](/hub/fdapulse/records/4)

- [Class II recall Z-0186-2027: INTELERAD MEDICAL SYSTEMS INCORPORATED](/report/fdapulse/class-ii-recall-z-0186-2027--z-0186-2027)
- [Class II recall Z-0190-2027: Radiometer Medical ApS](/report/fdapulse/class-ii-recall-z-0190-2027--z-0190-2027)
- [Class II recall Z-0205-2027: TECHNO-PATH MANUFACTURING LTD.](/report/fdapulse/class-ii-recall-z-0205-2027--z-0205-2027)
- [Class II recall Z-0206-2027: TECHNO-PATH MANUFACTURING LTD.](/report/fdapulse/class-ii-recall-z-0206-2027--z-0206-2027)
- [Class II recall Z-0207-2027: TECHNO-PATH MANUFACTURING LTD.](/report/fdapulse/class-ii-recall-z-0207-2027--z-0207-2027)
- [Class II recall Z-0211-2027: Life Technologies Holdings Pte Ltd](/report/fdapulse/class-ii-recall-z-0211-2027--z-0211-2027)
- [Class II recall Z-0223-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0223-2027--z-0223-2027)
- [Class II recall Z-0224-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0224-2027--z-0224-2027)
- [Class II recall Z-0225-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0225-2027--z-0225-2027)
- [Class II recall Z-0226-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0226-2027--z-0226-2027)
- [Class II recall Z-0227-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0227-2027--z-0227-2027)
- [Class II recall Z-0228-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0228-2027--z-0228-2027)
- [Class II recall Z-0229-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0229-2027--z-0229-2027)
- [Class II recall Z-0230-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0230-2027--z-0230-2027)
- [Class II recall Z-0231-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0231-2027--z-0231-2027)
- [Class II recall Z-0232-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0232-2027--z-0232-2027)
- [Class II recall Z-0233-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0233-2027--z-0233-2027)
- [Class II recall Z-0234-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0234-2027--z-0234-2027)
- [Class II recall Z-0235-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0235-2027--z-0235-2027)
- [Class II recall Z-0236-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0236-2027--z-0236-2027)
- [Class II recall Z-0237-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0237-2027--z-0237-2027)
- [Class II recall Z-0238-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0238-2027--z-0238-2027)
- [Class II recall Z-0239-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0239-2027--z-0239-2027)
- [Class II recall Z-0240-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0240-2027--z-0240-2027)
- [Class II recall Z-0241-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0241-2027--z-0241-2027)
- [Class II recall Z-0242-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0242-2027--z-0242-2027)
- [Class II recall Z-0243-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0243-2027--z-0243-2027)
- [Class II recall Z-0244-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0244-2027--z-0244-2027)
- [Class II recall Z-0245-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0245-2027--z-0245-2027)
- [Class II recall Z-0246-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0246-2027--z-0246-2027)
- [Class II recall Z-0247-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0247-2027--z-0247-2027)
- [Class II recall Z-0248-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0248-2027--z-0248-2027)
- [Class II recall Z-0249-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0249-2027--z-0249-2027)
- [Class II recall Z-0250-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0250-2027--z-0250-2027)
- [Class II recall Z-0251-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0251-2027--z-0251-2027)
- [Class II recall Z-0252-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0252-2027--z-0252-2027)
- [Class II recall Z-0253-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0253-2027--z-0253-2027)
- [Class II recall Z-0254-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0254-2027--z-0254-2027)
- [Class II recall Z-0255-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0255-2027--z-0255-2027)
- [Class II recall Z-0256-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0256-2027--z-0256-2027)
- [Class II recall Z-0257-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0257-2027--z-0257-2027)
- [Class II recall Z-0258-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0258-2027--z-0258-2027)
- [Class II recall Z-0259-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0259-2027--z-0259-2027)
- [Class II recall Z-0260-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0260-2027--z-0260-2027)
- [Class II recall Z-0261-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0261-2027--z-0261-2027)
- [Class II recall Z-0262-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0262-2027--z-0262-2027)
- [Class II recall Z-0263-2027: Boston Scientific Cork, Ltd.](/report/fdapulse/class-ii-recall-z-0263-2027--z-0263-2027)
- [Class II recall Z-3277-2026: Shanghai United Imaging Healthcare Co., Ltd.](/report/fdapulse/class-ii-recall-z-3277-2026--z-3277-2026)
- [Class II recall Z-3278-2026: Shanghai United Imaging Healthcare Co., Ltd.](/report/fdapulse/class-ii-recall-z-3278-2026--z-3278-2026)
- [Class II recall Z-3279-2026: Shanghai United Imaging Healthcare Co., Ltd.](/report/fdapulse/class-ii-recall-z-3279-2026--z-3279-2026)
- [Class II recall Z-3280-2026: Shanghai United Imaging Healthcare Co., Ltd.](/report/fdapulse/class-ii-recall-z-3280-2026--z-3280-2026)
- [Class II recall Z-3281-2026: Shanghai United Imaging Healthcare Co., Ltd.](/report/fdapulse/class-ii-recall-z-3281-2026--z-3281-2026)
- [Class II recall Z-3282-2026: Shanghai United Imaging Healthcare Co., Ltd.](/report/fdapulse/class-ii-recall-z-3282-2026--z-3282-2026)
- [Class II recall Z-3283-2026: Shanghai United Imaging Healthcare Co., Ltd.](/report/fdapulse/class-ii-recall-z-3283-2026--z-3283-2026)
- [Class II recall Z-3284-2026: Shanghai United Imaging Healthcare Co., Ltd.](/report/fdapulse/class-ii-recall-z-3284-2026--z-3284-2026)
- [Class II recall Z-3285-2026: Shanghai United Imaging Healthcare Co., Ltd.](/report/fdapulse/class-ii-recall-z-3285-2026--z-3285-2026)
- [Class II recall Z-3286-2026: Shanghai United Imaging Healthcare Co., Ltd.](/report/fdapulse/class-ii-recall-z-3286-2026--z-3286-2026)
- [Class II recall Z-3287-2026: Shanghai United Imaging Healthcare Co., Ltd.](/report/fdapulse/class-ii-recall-z-3287-2026--z-3287-2026)
- [Class II recall Z-3288-2026: Shanghai United Imaging Healthcare Co., Ltd.](/report/fdapulse/class-ii-recall-z-3288-2026--z-3288-2026)
- [Class II recall Z-3301-2026: Heraeus Medical GmbH (Dental Division)](/report/fdapulse/class-ii-recall-z-3301-2026--z-3301-2026)
- [Class II recall Z-3302-2026: Heraeus Medical GmbH (Dental Division)](/report/fdapulse/class-ii-recall-z-3302-2026--z-3302-2026)
- [Class II recall Z-3303-2026: Heraeus Medical GmbH (Dental Division)](/report/fdapulse/class-ii-recall-z-3303-2026--z-3303-2026)
- [Class II recall Z-3304-2026: Heraeus Medical GmbH (Dental Division)](/report/fdapulse/class-ii-recall-z-3304-2026--z-3304-2026)
- [Class II recall Z-3306-2026: NOXBOX LTD](/report/fdapulse/class-ii-recall-z-3306-2026--z-3306-2026)
- [Class II recall Z-3327-2026: SPECTRUM MEDICAL SRL](/report/fdapulse/class-ii-recall-z-3327-2026--z-3327-2026)
- [Class II recall Z-3328-2026: SPECTRUM MEDICAL SRL](/report/fdapulse/class-ii-recall-z-3328-2026--z-3328-2026)
- [Class II recall Z-3332-2026: Beckman Coulter Mishima K.K.](/report/fdapulse/class-ii-recall-z-3332-2026--z-3332-2026)
- [Class III recall Z-3270-2026: HeartSine Technologies Ltd](/report/fdapulse/class-iii-recall-z-3270-2026--z-3270-2026)

## AE

- [Artificial Intelligence Renal Assessment (AIRA) Version 1 (K261677): 510(k) cleared for Aramis Global AI Consultancies, LLC](/report/fdapulse/artificial-intelligence-renal-assessment-aira-version-1-ae--k261677)

## Arizona

- [Class II recall Z-0085-2027: Stryker Sustainability Solutions](/report/fdapulse/class-ii-recall-z-0085-2027-az--z-0085-2027)
- [Class II recall Z-0158-2027: W L Gore & Associates, Inc.](/report/fdapulse/class-ii-recall-z-0158-2027-az--z-0158-2027)
- [Class II recall Z-3275-2026: Bard Peripheral Vascular Inc](/report/fdapulse/class-ii-recall-z-3275-2026-az--z-3275-2026)
- [ProRib Fixation System (K261892): 510(k) cleared for Costa Surgical, Inc.](/report/fdapulse/prorib-fixation-system-k261892-az--k261892)
- [Reprocessed BRK Transseptal Needle (K262917): 510(k) cleared for Innovative Health, LLC](/report/fdapulse/reprocessed-brk-transseptal-needle-k262917-az--k262917)
- [VENTANA MMR IHC Panel (K260776): 510(k) cleared for Roche Tissue Diagnostics, Inc.](/report/fdapulse/ventana-mmr-ihc-panel-k260776-az--k260776)

## AU

- [Fertilis microICSI Device (K262090): 510(k) cleared for Fertilis Pty, Ltd.](/report/fdapulse/fertilis-microicsi-device-k262090-au--k262090)
- [Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG) (K262068): 510(k) cleared for CathRx, Ltd.](/report/fdapulse/khelix-magnetic-sensor-electrophysiology-catheter-ss1-mag-au--k262068)

## BE

- [CMF Titanium Splints (K260913): 510(k) cleared for Materialise NV](/report/fdapulse/cmf-titanium-splints-k260913-be--k260913)
- [Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630) (K262412): 510(k) cleared for Barco NV](/report/fdapulse/coronis-fusion-4mp-mdcc-4630-coronis-fusion-6mp-mdcc-6630-be--k262412)
- [HipStudio Analysis (K262442): 510(k) cleared for Replasia BV](/report/fdapulse/hipstudio-analysis-k262442-be--k262442)
- [Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where “x” may be any numeric character). (K261469): 510(k) cleared for Barco N.V.](/report/fdapulse/nexxis-2-nexxis-or-2-nms-2-mna-240-mna-4x0-where-x-may-be--k261469)
- [Wishbone HAE (K260096): 510(k) cleared for Wishbone SA](/report/fdapulse/wishbone-hae-k260096-be--k260096)

## BR

- [S.I.N. Instruments Kits (K262084): 510(k) cleared for S.I.N. Implant System Ltda](/report/fdapulse/s-i-n-instruments-kits-k262084-br--k262084)

## California

- [7D Surgical System (10-0001) (K260403): 510(k) cleared for 7D Surgical ULC](/report/fdapulse/7d-surgical-system-10-0001-k260403-ca--k260403)
- [Accelagen Advanced Surgical Collagen Matrix, 1cc (CG-01AA); Accelagen Advanced Surgical Collagen Matrix, 2cc (CG-02AA); Accelagen Advanced Surgical Collagen Matrix, 3cc (CG-03AA); Accelagen Advanced Surgical Collagen Matrix, 5cc (CG-05AA); Accelagen Advanced Surgical Collagen Strip, 125x25x2mm (CG-1](/report/fdapulse/accelagen-advanced-surgical-collagen-matrix-1cc-cg-01aa-ca--k260920)
- [APRO 88 Catheter (K261938): 510(k) cleared for Alembic, LLC](/report/fdapulse/apro-88-catheter-k261938-ca--k261938)
- [BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5) (K260215): 510(k) cleared for Bd Biosciences](/report/fdapulse/bd-oneflow-lst-bd-oneflow-b-clpd-t1-bd-facslyric-flow-ca--k260215)
- [Biolinq Shine Autonomous Time-in-Range Microsensor (K262599): 510(k) cleared for Biolinq Incorporated](/report/fdapulse/biolinq-shine-autonomous-time-in-range-microsensor-k262599-ca--k262599)
- [BlineSlide (K261679): 510(k) cleared for Deep Breathe, Inc.](/report/fdapulse/blineslide-k261679-ca--k261679)
- [Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody System (K262646): 510(k) cleared for Alphatec Spine, Inc.](/report/fdapulse/calibrate-max-system-calibrate-nanotec-max-system-calibrate-ca--k262646)
- [CapsoView (CVV); CapsoCloud (CLD) (K254230): 510(k) cleared for CapsoVision, Inc.](/report/fdapulse/capsoview-cvv-capsocloud-cld-k254230-ca--k254230)
- [Carecube Negative Pressure Isolation Chamber (1BY) (K260180): 510(k) cleared for Carecubes, Inc.](/report/fdapulse/carecube-negative-pressure-isolation-chamber-1by-k260180-ca--k260180)
- [Ceribell EEG Analysis Software (K261712): 510(k) cleared for Ceribell, Inc.](/report/fdapulse/ceribell-eeg-analysis-software-k261712-ca--k261712)
- [Class II recall Z-0068-2027: Illumina, Inc.](/report/fdapulse/class-ii-recall-z-0068-2027-ca--z-0068-2027)
- [Class II recall Z-0083-2027: Beckman Coulter Inc.](/report/fdapulse/class-ii-recall-z-0083-2027-ca--z-0083-2027)
- [Class II recall Z-0084-2027: Beckman Coulter Inc.](/report/fdapulse/class-ii-recall-z-0084-2027-ca--z-0084-2027)
- [Class II recall Z-0088-2027: Medtronic MiniMed, Inc.](/report/fdapulse/class-ii-recall-z-0088-2027-ca--z-0088-2027)
- [Class II recall Z-0089-2027: Nihon Kohden America LLC](/report/fdapulse/class-ii-recall-z-0089-2027-ca--z-0089-2027)
- [Class II recall Z-0108-2027: Canon Medical System, USA, INC.](/report/fdapulse/class-ii-recall-z-0108-2027-ca--z-0108-2027)
- [Class II recall Z-0134-2027: Jenavalve Technology Inc.](/report/fdapulse/class-ii-recall-z-0134-2027-ca--z-0134-2027)
- [Class II recall Z-0135-2027: Jenavalve Technology Inc.](/report/fdapulse/class-ii-recall-z-0135-2027-ca--z-0135-2027)
- [Class II recall Z-0136-2027: Jenavalve Technology Inc.](/report/fdapulse/class-ii-recall-z-0136-2027-ca--z-0136-2027)
- [Class II recall Z-0146-2027: SI-BONE, Inc.](/report/fdapulse/class-ii-recall-z-0146-2027-ca--z-0146-2027)
- [Class II recall Z-0159-2027: Microgenics Corporation](/report/fdapulse/class-ii-recall-z-0159-2027-ca--z-0159-2027)
- [Class II recall Z-0192-2027: Think Surgical, Inc.](/report/fdapulse/class-ii-recall-z-0192-2027-ca--z-0192-2027)
- [Class II recall Z-0198-2027: Axonics, Inc.](/report/fdapulse/class-ii-recall-z-0198-2027-ca--z-0198-2027)
- [Class II recall Z-0203-2027: Medtronic MiniMed, Inc.](/report/fdapulse/class-ii-recall-z-0203-2027-ca--z-0203-2027)
- [Class II recall Z-0265-2027: Medtronic MiniMed, Inc.](/report/fdapulse/class-ii-recall-z-0265-2027-ca--z-0265-2027)
- [Class II recall Z-3271-2026: Alere San Diego, Inc.](/report/fdapulse/class-ii-recall-z-3271-2026-ca--z-3271-2026)
- [Class II recall Z-3272-2026: Alere San Diego, Inc.](/report/fdapulse/class-ii-recall-z-3272-2026-ca--z-3272-2026)
- [Class II recall Z-3273-2026: Alere San Diego, Inc.](/report/fdapulse/class-ii-recall-z-3273-2026-ca--z-3273-2026)
- [Class II recall Z-3274-2026: Alere San Diego, Inc.](/report/fdapulse/class-ii-recall-z-3274-2026-ca--z-3274-2026)
- [Class II recall Z-3276-2026: Volcano Corp](/report/fdapulse/class-ii-recall-z-3276-2026-ca--z-3276-2026)
- [Class II recall Z-3326-2026: Micro Therapeutics, Inc.](/report/fdapulse/class-ii-recall-z-3326-2026-ca--z-3326-2026)
- [Class II recall Z-3330-2026: Tandem Diabetes Care, Inc.](/report/fdapulse/class-ii-recall-z-3330-2026-ca--z-3330-2026)
- [Class II recall Z-3331-2026: Penumbra Inc.](/report/fdapulse/class-ii-recall-z-3331-2026-ca--z-3331-2026)
- [Class II recall Z-3333-2026: Karl Storz Endoscopy](/report/fdapulse/class-ii-recall-z-3333-2026-ca--z-3333-2026)
- [ClearClub Impression Material (K261888): 510(k) cleared for ClearClub](/report/fdapulse/clearclub-impression-material-k261888-ca--k261888)
- [corra® cervical plating system (K262149): 510(k) cleared for Carlsmed, Inc.](/report/fdapulse/corra-cervical-plating-system-k262149-ca--k262149)
- [CrossFAST Integrated Microcatheter Advanced Delivery System (K262817): 510(k) cleared for Vantis Vascular, Inc.](/report/fdapulse/crossfast-integrated-microcatheter-advanced-delivery-system-ca--k262817)
- [CVAC® Aspiration System (K261447): 510(k) cleared for Calyxo, Inc.](/report/fdapulse/cvac-aspiration-system-k261447-ca--k261447)
- [da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System (K262455): 510(k) cleared for Intuitive Surgical, Inc.](/report/fdapulse/da-vinci-5-handheld-camera-head-470080-da-vinci-5-handheld-ca--k262455)
- [Daybreak Impression Material (K262421): 510(k) cleared for Sleepcare, LLC](/report/fdapulse/daybreak-impression-material-k262421-ca--k262421)
- [DistaSense(TM) (v1) (K254058): 510(k) cleared for Life Detection Technologies](/report/fdapulse/distasense-tm-v1-k254058-ca--k254058)
- [ElintMAX Respiratory Monitor (ElintMAX Monitor A1) (K260226): 510(k) cleared for Amptron Medical, Inc.](/report/fdapulse/elintmax-respiratory-monitor-elintmax-monitor-a1-k260226-ca--k260226)
- [Excelsior Reach Microcatheter (K261649): 510(k) cleared for Stryker Neurovascular](/report/fdapulse/excelsior-reach-microcatheter-k261649-ca--k261649)
- [Forza (K260136): 510(k) cleared for True Function Laboratory, Inc.](/report/fdapulse/forza-k260136-ca--k260136)
- [Helo™ Return (K253717): 510(k) cleared for Endovascular Engineering, Inc.](/report/fdapulse/helo-return-k253717-ca--k253717)
- [iFuse Granite Onyx™ Implant System (K262067): 510(k) cleared for SI-BONE, Inc.](/report/fdapulse/ifuse-granite-onyx-implant-system-k262067-ca--k262067)
- [INDIGO® Aspiration System (K262904): 510(k) cleared for Penumbra, Inc.](/report/fdapulse/indigo-aspiration-system-k262904-ca--k262904)
- [InkSpace Imaging Small Body Array (SBA12PH15x) (K262813): 510(k) cleared for Inkspace Imaging, Inc.](/report/fdapulse/inkspace-imaging-small-body-array-sba12ph15x-k262813-ca--k262813)
- [Instant-View® hCG Combo II Cassette Test (K262299): 510(k) cleared for Alfa Scientific Designs, Inc.](/report/fdapulse/instant-view-hcg-combo-ii-cassette-test-k262299-ca--k262299)
- [Invisalign System (K262196): 510(k) cleared for Align Technology, Inc.](/report/fdapulse/invisalign-system-k262196-ca--k262196)
- [LOBO Vascular Occlusion System (K262798): 510(k) cleared for Okami Medical, Inc.](/report/fdapulse/lobo-vascular-occlusion-system-k262798-ca--k262798)
- [Mint ACE Pump (K260001): 510(k) cleared for Beta Bionics, Inc.](/report/fdapulse/mint-ace-pump-k260001-ca--k260001)
- [Mint ACE Pump (K263422): 510(k) cleared for Beta Bionics, Inc.](/report/fdapulse/mint-ace-pump-k263422-ca--k263422)
- [MPa Max adhesive (K262252): 510(k) cleared for Den-Mat Holdings, LLC](/report/fdapulse/mpa-max-adhesive-k262252-ca--k262252)
- [Pathfinder Endoscope Overtube (K262262): 510(k) cleared for Neptune Medical, Inc.](/report/fdapulse/pathfinder-endoscope-overtube-k262262-ca--k262262)
- [QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W) (K260250): 510(k) cleared for QT Medical, Inc.](/report/fdapulse/qca-10-electrocardiograph-qcard-10-qca-10w-ca--k260250)
- [Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit (K261089): 510(k) cleared for Maduro Medical, Inc.](/report/fdapulse/radical-064-reperfusion-catheter-radical-076-reperfusion-ca--k261089)
- [Radius VSM and Accessories (K260676): 510(k) cleared for Masimo Corporation](/report/fdapulse/radius-vsm-and-accessories-k260676-ca--k260676)
- [Rapid Barostat Bag (RBB) Pump and Catheter System (K262621): 510(k) cleared for Mui Scientific, Inc.](/report/fdapulse/rapid-barostat-bag-rbb-pump-and-catheter-system-k262621-ca--k262621)
- [Route 92 Medical Full Length 046 Access System (K260220): 510(k) cleared for Route 92 Medical, Inc.](/report/fdapulse/route-92-medical-full-length-046-access-system-k260220-ca--k260220)
- [Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set (K263266): 510(k) cleared for Route 92 Medical, Inc.](/report/fdapulse/route-92-medical-full-length-046-reperfusion-system-and-ca--k263266)
- [SABER-C System (K263049): 510(k) cleared for Elevation Spine](/report/fdapulse/saber-c-system-k263049-ca--k263049)
- [Spinalogic Bone Growth Stimulator (K262721): 510(k) cleared for Djo, LLC](/report/fdapulse/spinalogic-bone-growth-stimulator-k262721-ca--k262721)
- [Syneris PACS v.1.0.1.0 (K261874): 510(k) cleared for Syneris](/report/fdapulse/syneris-pacs-v-1-0-1-0-k261874-ca--k261874)
- [The Circadia CX00 System (CX00) (K262447): 510(k) cleared for Circadia Health, Inc.](/report/fdapulse/the-circadia-cx00-system-cx00-k262447-ca--k262447)
- [The D-Tip Denudation Pipette (K261234): 510(k) cleared for Allwin Medical Devices, Inc.](/report/fdapulse/the-d-tip-denudation-pipette-k261234-ca--k261234)
- [TMINI Miniature Robotic System (K263234): 510(k) cleared for THINK Surgical, Inc.](/report/fdapulse/tmini-miniature-robotic-system-k263234-ca--k263234)
- [Toro 71 Aspiration Catheter; Toro Aspiration Tubing (K262021): 510(k) cleared for Toro Neurovascular, Inc.](/report/fdapulse/toro-71-aspiration-catheter-toro-aspiration-tubing-k262021-ca--k262021)
- [TriActive Dental Implant System (K261392): 510(k) cleared for Paragon Implant Mfg., LLC](/report/fdapulse/triactive-dental-implant-system-k261392-ca--k261392)
- [Triever Duo Catheter (K253419): 510(k) cleared for Inari Medical, Inc.](/report/fdapulse/triever-duo-catheter-k253419-ca--k253419)
- [VenusCT (K260510): 510(k) cleared for Linatech, LLC](/report/fdapulse/venusct-k260510-ca--k260510)
- [Vista AI Scan (K260092): 510(k) cleared for Vista AI, Inc.](/report/fdapulse/vista-ai-scan-k260092-ca--k260092)
- [X°Port Heart Preservation System (K261913): 510(k) cleared for Traferox Technologies, Inc.](/report/fdapulse/x-port-heart-preservation-system-k261913-ca--k261913)
- [Xpert Respiratory Panel (K261336): 510(k) cleared for Cepheid](/report/fdapulse/xpert-respiratory-panel-k261336-ca--k261336)
- [Xpert Xpress CoV-2/Flu plus (K263120): 510(k) cleared for Cepheid®](/report/fdapulse/xpert-xpress-cov-2-flu-plus-k263120-ca--k263120)
- [Xpert Xpress CoV-2/Flu plus (K263333): 510(k) cleared for Cepheid®](/report/fdapulse/xpert-xpress-cov-2-flu-plus-k263333-ca--k263333)

## CH

- [CAS-One IR (K261225): 510(k) cleared for Cascination AG](/report/fdapulse/cas-one-ir-k261225-ch--k261225)
- [DRIM-Nail System (K260115): 510(k) cleared for 41Medical AG](/report/fdapulse/drim-nail-system-k260115-ch--k260115)
- [ErgoSteel (ES0001/696) (K253762): 510(k) cleared for Strongback Mobility AG C/O Blueaudit GmbH](/report/fdapulse/ergosteel-es0001-696-k253762-ch--k253762)
- [GMK Extension (K262057): 510(k) cleared for Medacta International SA](/report/fdapulse/gmk-extension-k262057-ch--k262057)
- [M-Vizion Femoral Revision System Extension (K260173): 510(k) cleared for Medacta International S.A.](/report/fdapulse/m-vizion-femoral-revision-system-extension-k260173-ch--k260173)
- [One Coat Bond; One Coat Bond SL (K263680): 510(k) cleared for Dent4You AG](/report/fdapulse/one-coat-bond-one-coat-bond-sl-k263680-ch--k263680)
- [OTOPLAN (K262080): 510(k) cleared for Cascination AG](/report/fdapulse/otoplan-k262080-ch--k262080)

## CN

- [308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A) (K262885): 510(k) cleared for Guangxi Hope Medical Devices Technology Co., Ltd.](/report/fdapulse/308nm-ultraviolet-light-therapy-device-xwyl-401a-xwyl-403a-cn--k262885)
- [Air compression massager (ACM-C1, ACM-C2, ACM-C3, ACM-C4, ACM-C5, ACM-C6, ACM-C7, ACM-C8, ACM-C9, ACM-5C1, ACM-5C2, ACM-5C3, ACM-5C4, ACM-5C5, ACM-5C6, ACM-5C7, ACM-5C8, ACM-5C9) (K262812): 510(k) cleared for Sichuan Qianli-Beoka Medical Technology, Inc.](/report/fdapulse/air-compression-massager-acm-c1-acm-c2-acm-c3-acm-c4-acm-c5-cn--k262812)
- [AMIRO Spectra 10-in-1 LED Light Therapy Mask (L3) (K262932): 510(k) cleared for Shenzhen Accompany Technology Co., Ltd.](/report/fdapulse/amiro-spectra-10-in-1-led-light-therapy-mask-l3-k262932-cn--k262932)
- [Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C) (K260141): 510(k) cleared for Zhenjiang Assure Medical Equipment Co., Ltd.](/report/fdapulse/bariatric-heavy-duty-wheelchair-yj-010v-yj-010c-k260141-cn--k260141)
- [BreathCare PAP III (YH-390N) (K260251): 510(k) cleared for Suzhou Yuyue Medical Technology Co., Ltd.](/report/fdapulse/breathcare-pap-iii-yh-390n-k260251-cn--k260251)
- [CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight Medical Diode Laser Systems (S3-BF30);CureLight Medical Diode Laser Systems (S2-F15);CureLight Medical Diode Laser Systems (S2-H7.5) (K262346): 510(k) cleared for Wuhan Phomed Technology Co., Ltd](/report/fdapulse/curelight-medical-diode-laser-systems-s3-bf45-curelight-cn--k262346)
- [Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) (K263033): 510(k) cleared for Fussen Technology Co., Ltd.](/report/fdapulse/dental-computed-tomography-x-ray-system-rubik-xsmart-rubik-cn--k263033)
- [Dental Diode Laser Device (Laser-Pen) (K261047): 510(k) cleared for Guilin Kevin Peter Technology Co., Ltd.](/report/fdapulse/dental-diode-laser-device-laser-pen-k261047-cn--k261047)
- [Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound System (Nuewa A20 Exp); Diagnostic Ultrasound System (Nuewa A20 Elite); Diagnostic Ultrasound System (Nuewa A20Q); Diagnostic Ultrasound System (Nuewa A MV); Diagnostic Ultrasound System (Nuewa](/report/fdapulse/diagnostic-ultrasound-system-nuewa-a20w-diagnostic-cn--k261585)
- [Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic Ultrasound System (Resona I10);Diagnostic Ultrasound System (Resona I10S);Diagnostic Ultrasound System (Resona XI);Diagnostic Ultrasound System (Resona I10 CV);Diagnostic Ultrasound System (Nuewa I10W](/report/fdapulse/diagnostic-ultrasound-system-resona-i10w-diagnostic-cn--k261617)
- [Diode Laser Hair Removal Machine (QDTM-03) (K261692): 510(k) cleared for Beijing Nubway S&T Co., Ltd.](/report/fdapulse/diode-laser-hair-removal-machine-qdtm-03-k261692-cn--k261692)
- [Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) (K261817): 510(k) cleared for Zhengzhou PZ Laser Slim Technology Co., Ltd.](/report/fdapulse/diode-laser-therapy-system-pz-bdt67-01-pz-bdt67-02-k261817-cn--k261817)
- [Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1) (K263254): 510(k) cleared for Xiamen Compower Medical Tech. Co., Ltd.](/report/fdapulse/disposable-manual-resuscitator-npvc-001-rtma-npvc-002-rtma-cn--k263254)
- [Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S) (K262214): 510(k) cleared for Guangzhou Aimooe Technology Co., Ltd.](/report/fdapulse/disposable-reflective-marker-spheres-am-bk115s-am-bl130s-cn--k262214)
- [Disposable Sterile Skull Drill (LZ) (K254177): 510(k) cleared for Guizhou Zirui Technology Co., Ltd.](/report/fdapulse/disposable-sterile-skull-drill-lz-k254177-cn--k254177)
- [Disposable Ureteral Access Sheath (K260512): 510(k) cleared for Yangzhou Fartley Medical Instrument Technology Co., Ltd.](/report/fdapulse/disposable-ureteral-access-sheath-k260512-cn--k260512)
- [Drainage Catheter (K254179): 510(k) cleared for Canyon Medical, Inc.](/report/fdapulse/drainage-catheter-k254179-cn--k254179)
- [easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges (K254291): 510(k) cleared for Ezisurg Medical Co., Ltd.](/report/fdapulse/easyendo-e-lite-single-use-powered-endoscopic-staplers-cn--k254291)
- [Electric Scooter (FDB08, FDB08A, FDB12) (K261859): 510(k) cleared for Anhui JBH Medical Apparatus Co., Ltd.](/report/fdapulse/electric-scooter-fdb08-fdb08a-fdb12-k261859-cn--k261859)
- [Electric Scooter (FNS01,FNS03) (K261078): 510(k) cleared for Anhui Jbh Medical Apparatus Co., Ltd.](/report/fdapulse/electric-scooter-fns01-fns03-k261078-cn--k261078)
- [Electric Wheelchair (0080) (K262241): 510(k) cleared for Xuzhou Heabens Medical Technology Co., Ltd.](/report/fdapulse/electric-wheelchair-0080-k262241-cn--k262241)
- [Electric Wheelchair (CN501) (K262652): 510(k) cleared for Zhejiang Shimo Technology Co., Ltd.](/report/fdapulse/electric-wheelchair-cn501-k262652-cn--k262652)
- [Electric wheelchair (GP100) (K262582): 510(k) cleared for Suzhou Green Pine Medical Co., Ltd.](/report/fdapulse/electric-wheelchair-gp100-k262582-cn--k262582)
- [Electric Wheelchair (K262054): 510(k) cleared for Yongkang Joymax Medical Technology Co., Ltd.](/report/fdapulse/electric-wheelchair-k262054-cn--k262054)
- [Electrically Powered Wheelchair (YC-01) (K263257): 510(k) cleared for Yurob Rehabilitation Medical Co., Ltd.](/report/fdapulse/electrically-powered-wheelchair-yc-01-k263257-cn--k263257)
- [Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C, BP-202 BP-205, BP-205B,BP-206) (K260470): 510(k) cleared for Shenzhen Brav Electronic Technologies Co., Ltd.](/report/fdapulse/electronic-blood-pressure-monitor-bp-204c-bp-204a-bp-215-bp-cn--k260470)
- [Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9) (K262752): 510(k) cleared for Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.](/report/fdapulse/facial-therapy-mask-z1-z2-z3-z5-z6-z7-z8-z9-k262752-cn--k262752)
- [FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant (Plain);FAMA Male Latex Condoms – Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms – Aqueous Lubricant (Dotted);FAMA Male Latex Condoms – Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condom](/report/fdapulse/fama-male-latex-condoms-aqueous-lubricant-ultra-thin-fama-cn--k262108)
- [Giranel Guiding Sheath Set (K262674): 510(k) cleared for Kossel Medtech (Suzhou) Co., Ltd.](/report/fdapulse/giranel-guiding-sheath-set-k262674-cn--k262674)
- [H100Plus Hemoglobin Testing System (K260468): 510(k) cleared for Shenzhen Lifotronic Technology Co., Ltd.](/report/fdapulse/h100plus-hemoglobin-testing-system-k260468-cn--k260468)
- [Hair Growth Comb (X-GC01) (K262254): 510(k) cleared for Guangdong Ashmore Health Technology Co., Ltd.](/report/fdapulse/hair-growth-comb-x-gc01-k262254-cn--k262254)
- [Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60) (K262183): 510(k) cleared for Shenzhen Nuon Medical Equipment Co., Ltd.](/report/fdapulse/hair-growth-helmet-tk-176-tk-600-tk-500-tk-282-tk-500a-tk-cn--k262183)
- [Hand-held Dental X-ray System (HyperLight-M) (K260795): 510(k) cleared for Changzhou Sifary Medical Technology Co., Ltd.](/report/fdapulse/hand-held-dental-x-ray-system-hyperlight-m-k260795-cn--k260795)
- [Hemostatic Clip (K261741): 510(k) cleared for Anrei Medical (Hz) Co., Ltd.](/report/fdapulse/hemostatic-clip-k261741-cn--k261741)

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