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.

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

AE

• Artificial Intelligence Renal Assessment (AIRA) Version 1 (K261677): 510(k) cleared for Aramis Global AI Consultancies, LLC

Arizona

• Class II recall Z-0085-2027: Stryker Sustainability Solutions
• Class II recall Z-0158-2027: W L Gore & Associates, Inc.
• Class II recall Z-3275-2026: Bard Peripheral Vascular Inc
• ProRib Fixation System (K261892): 510(k) cleared for Costa Surgical, Inc.
• Reprocessed BRK Transseptal Needle (K262917): 510(k) cleared for Innovative Health, LLC
• VENTANA MMR IHC Panel (K260776): 510(k) cleared for Roche Tissue Diagnostics, Inc.

AU

• Fertilis microICSI Device (K262090): 510(k) cleared for Fertilis Pty, Ltd.
• Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG) (K262068): 510(k) cleared for CathRx, Ltd.

BE

• CMF Titanium Splints (K260913): 510(k) cleared for Materialise NV
• Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630) (K262412): 510(k) cleared for Barco NV
• HipStudio Analysis (K262442): 510(k) cleared for Replasia BV
• 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.
• Wishbone HAE (K260096): 510(k) cleared for Wishbone SA

BR

• S.I.N. Instruments Kits (K262084): 510(k) cleared for S.I.N. Implant System Ltda

California

• 7D Surgical System (10-0001) (K260403): 510(k) cleared for 7D Surgical ULC
• 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
• APRO 88 Catheter (K261938): 510(k) cleared for Alembic, LLC
• 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
• Biolinq Shine Autonomous Time-in-Range Microsensor (K262599): 510(k) cleared for Biolinq Incorporated
• BlineSlide (K261679): 510(k) cleared for Deep Breathe, Inc.
• Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody System (K262646): 510(k) cleared for Alphatec Spine, Inc.
• CapsoView (CVV); CapsoCloud (CLD) (K254230): 510(k) cleared for CapsoVision, Inc.
• Carecube Negative Pressure Isolation Chamber (1BY) (K260180): 510(k) cleared for Carecubes, Inc.
• Ceribell EEG Analysis Software (K261712): 510(k) cleared for Ceribell, Inc.
• Class II recall Z-0068-2027: Illumina, Inc.
• Class II recall Z-0083-2027: Beckman Coulter Inc.
• Class II recall Z-0084-2027: Beckman Coulter Inc.
• Class II recall Z-0088-2027: Medtronic MiniMed, Inc.
• Class II recall Z-0089-2027: Nihon Kohden America LLC
• Class II recall Z-0108-2027: Canon Medical System, USA, INC.
• Class II recall Z-0134-2027: Jenavalve Technology Inc.
• Class II recall Z-0135-2027: Jenavalve Technology Inc.
• Class II recall Z-0136-2027: Jenavalve Technology Inc.
• Class II recall Z-0146-2027: SI-BONE, Inc.
• Class II recall Z-0159-2027: Microgenics Corporation
• Class II recall Z-0192-2027: Think Surgical, Inc.
• Class II recall Z-0198-2027: Axonics, Inc.
• Class II recall Z-0203-2027: Medtronic MiniMed, Inc.
• Class II recall Z-0265-2027: Medtronic MiniMed, Inc.
• Class II recall Z-3271-2026: Alere San Diego, Inc.
• Class II recall Z-3272-2026: Alere San Diego, Inc.
• Class II recall Z-3273-2026: Alere San Diego, Inc.
• Class II recall Z-3274-2026: Alere San Diego, Inc.
• Class II recall Z-3276-2026: Volcano Corp
• Class II recall Z-3326-2026: Micro Therapeutics, Inc.
• Class II recall Z-3330-2026: Tandem Diabetes Care, Inc.
• Class II recall Z-3331-2026: Penumbra Inc.
• Class II recall Z-3333-2026: Karl Storz Endoscopy
• ClearClub Impression Material (K261888): 510(k) cleared for ClearClub
• corra® cervical plating system (K262149): 510(k) cleared for Carlsmed, Inc.
• CrossFAST Integrated Microcatheter Advanced Delivery System (K262817): 510(k) cleared for Vantis Vascular, Inc.
• CVAC® Aspiration System (K261447): 510(k) cleared for Calyxo, Inc.
• 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.
• Daybreak Impression Material (K262421): 510(k) cleared for Sleepcare, LLC
• DistaSense(TM) (v1) (K254058): 510(k) cleared for Life Detection Technologies
• ElintMAX Respiratory Monitor (ElintMAX Monitor A1) (K260226): 510(k) cleared for Amptron Medical, Inc.
• Excelsior Reach Microcatheter (K261649): 510(k) cleared for Stryker Neurovascular
• Forza (K260136): 510(k) cleared for True Function Laboratory, Inc.
• Helo™ Return (K253717): 510(k) cleared for Endovascular Engineering, Inc.
• iFuse Granite Onyx™ Implant System (K262067): 510(k) cleared for SI-BONE, Inc.
• INDIGO® Aspiration System (K262904): 510(k) cleared for Penumbra, Inc.
• InkSpace Imaging Small Body Array (SBA12PH15x) (K262813): 510(k) cleared for Inkspace Imaging, Inc.
• Instant-View® hCG Combo II Cassette Test (K262299): 510(k) cleared for Alfa Scientific Designs, Inc.
• Invisalign System (K262196): 510(k) cleared for Align Technology, Inc.
• LOBO Vascular Occlusion System (K262798): 510(k) cleared for Okami Medical, Inc.
• Mint ACE Pump (K260001): 510(k) cleared for Beta Bionics, Inc.
• Mint ACE Pump (K263422): 510(k) cleared for Beta Bionics, Inc.
• MPa Max adhesive (K262252): 510(k) cleared for Den-Mat Holdings, LLC
• Pathfinder Endoscope Overtube (K262262): 510(k) cleared for Neptune Medical, Inc.
• QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W) (K260250): 510(k) cleared for QT Medical, Inc.
• Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit (K261089): 510(k) cleared for Maduro Medical, Inc.
• Radius VSM and Accessories (K260676): 510(k) cleared for Masimo Corporation
• Rapid Barostat Bag (RBB) Pump and Catheter System (K262621): 510(k) cleared for Mui Scientific, Inc.
• Route 92 Medical Full Length 046 Access System (K260220): 510(k) cleared for Route 92 Medical, Inc.
• Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set (K263266): 510(k) cleared for Route 92 Medical, Inc.
• SABER-C System (K263049): 510(k) cleared for Elevation Spine
• Spinalogic Bone Growth Stimulator (K262721): 510(k) cleared for Djo, LLC
• Syneris PACS v.1.0.1.0 (K261874): 510(k) cleared for Syneris
• The Circadia CX00 System (CX00) (K262447): 510(k) cleared for Circadia Health, Inc.
• The D-Tip Denudation Pipette (K261234): 510(k) cleared for Allwin Medical Devices, Inc.
• TMINI Miniature Robotic System (K263234): 510(k) cleared for THINK Surgical, Inc.
• Toro 71 Aspiration Catheter; Toro Aspiration Tubing (K262021): 510(k) cleared for Toro Neurovascular, Inc.
• TriActive Dental Implant System (K261392): 510(k) cleared for Paragon Implant Mfg., LLC
• Triever Duo Catheter (K253419): 510(k) cleared for Inari Medical, Inc.
• VenusCT (K260510): 510(k) cleared for Linatech, LLC
• Vista AI Scan (K260092): 510(k) cleared for Vista AI, Inc.
• X°Port Heart Preservation System (K261913): 510(k) cleared for Traferox Technologies, Inc.
• Xpert Respiratory Panel (K261336): 510(k) cleared for Cepheid
• Xpert Xpress CoV-2/Flu plus (K263120): 510(k) cleared for Cepheid®
• Xpert Xpress CoV-2/Flu plus (K263333): 510(k) cleared for Cepheid®

CH

• CAS-One IR (K261225): 510(k) cleared for Cascination AG
• DRIM-Nail System (K260115): 510(k) cleared for 41Medical AG
• ErgoSteel (ES0001/696) (K253762): 510(k) cleared for Strongback Mobility AG C/O Blueaudit GmbH
• GMK Extension (K262057): 510(k) cleared for Medacta International SA
• M-Vizion Femoral Revision System Extension (K260173): 510(k) cleared for Medacta International S.A.
• One Coat Bond; One Coat Bond SL (K263680): 510(k) cleared for Dent4You AG
• OTOPLAN (K262080): 510(k) cleared for Cascination AG

CN

• 308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A) (K262885): 510(k) cleared for Guangxi Hope Medical Devices Technology Co., Ltd.
• 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.
• AMIRO Spectra 10-in-1 LED Light Therapy Mask (L3) (K262932): 510(k) cleared for Shenzhen Accompany Technology Co., Ltd.
• Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C) (K260141): 510(k) cleared for Zhenjiang Assure Medical Equipment Co., Ltd.
• BreathCare PAP III (YH-390N) (K260251): 510(k) cleared for Suzhou Yuyue Medical Technology Co., Ltd.
• 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
• 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.
• Dental Diode Laser Device (Laser-Pen) (K261047): 510(k) cleared for Guilin Kevin Peter Technology Co., Ltd.
• 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
• 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
• Diode Laser Hair Removal Machine (QDTM-03) (K261692): 510(k) cleared for Beijing Nubway S&T Co., Ltd.
• Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) (K261817): 510(k) cleared for Zhengzhou PZ Laser Slim Technology Co., Ltd.
• Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1) (K263254): 510(k) cleared for Xiamen Compower Medical Tech. Co., Ltd.
• Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S) (K262214): 510(k) cleared for Guangzhou Aimooe Technology Co., Ltd.
• Disposable Sterile Skull Drill (LZ) (K254177): 510(k) cleared for Guizhou Zirui Technology Co., Ltd.
• Disposable Ureteral Access Sheath (K260512): 510(k) cleared for Yangzhou Fartley Medical Instrument Technology Co., Ltd.
• Drainage Catheter (K254179): 510(k) cleared for Canyon Medical, Inc.
• 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.
• Electric Scooter (FDB08, FDB08A, FDB12) (K261859): 510(k) cleared for Anhui JBH Medical Apparatus Co., Ltd.
• Electric Scooter (FNS01,FNS03) (K261078): 510(k) cleared for Anhui Jbh Medical Apparatus Co., Ltd.
• Electric Wheelchair (0080) (K262241): 510(k) cleared for Xuzhou Heabens Medical Technology Co., Ltd.
• Electric Wheelchair (CN501) (K262652): 510(k) cleared for Zhejiang Shimo Technology Co., Ltd.
• Electric wheelchair (GP100) (K262582): 510(k) cleared for Suzhou Green Pine Medical Co., Ltd.
• Electric Wheelchair (K262054): 510(k) cleared for Yongkang Joymax Medical Technology Co., Ltd.
• Electrically Powered Wheelchair (YC-01) (K263257): 510(k) cleared for Yurob Rehabilitation Medical Co., Ltd.
• 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.
• Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9) (K262752): 510(k) cleared for Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.
• 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
• Giranel Guiding Sheath Set (K262674): 510(k) cleared for Kossel Medtech (Suzhou) Co., Ltd.
• H100Plus Hemoglobin Testing System (K260468): 510(k) cleared for Shenzhen Lifotronic Technology Co., Ltd.
• Hair Growth Comb (X-GC01) (K262254): 510(k) cleared for Guangdong Ashmore Health Technology Co., Ltd.
• 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.
• Hand-held Dental X-ray System (HyperLight-M) (K260795): 510(k) cleared for Changzhou Sifary Medical Technology Co., Ltd.
• Hemostatic Clip (K261741): 510(k) cleared for Anrei Medical (Hz) Co., Ltd.

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