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- Page 2

# FDAPulse: all 764 record reports, page 2 of 4

Every FDAPulse record report, 200 per page, grouped by state. Records 201 to 400: IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202) (K262352): 510(k) cleared for Shenzhen Jianchao Intelligent Technology Co., Ltd. to Class II recall Z-0168-2027: Medline Industries, LP. Source: U.S. FDA openFDA.

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

## CN

- [IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202) (K262352): 510(k) cleared for Shenzhen Jianchao Intelligent Technology Co., Ltd.](/report/fdapulse/ipl-hair-removal-device-ahr01-r3c16-g-pro1-ahr02-ahr03-cn--k262352)
- [JADE SCORE PTA Scoring Balloon Dilatation Catheter (K261778): 510(k) cleared for OrbusNeich Medical (Shenzhen) Co., Ltd.](/report/fdapulse/jade-score-pta-scoring-balloon-dilatation-catheter-k261778-cn--k261778)
- [Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5630, H6510, H6520, INIA-HM100, ID-FLH-500) (K262834): 510(k) cleared for Shenzhen Jianchao Intelligent Technology Co., Ltd.](/report/fdapulse/led-and-laser-hair-growth-device-h5520-h5521-h5522-h5523-cn--k262834)
- [LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) (K261370): 510(k) cleared for Guangdong Newdermo Biotech Co., Ltd.](/report/fdapulse/led-light-therapy-masks-led-face-mask-pulse-fac06na-k261370-cn--k261370)
- [LED Therapy Device (QLXY-01) (K261673): 510(k) cleared for Beijing Nubway S&T Co., Ltd.](/report/fdapulse/led-therapy-device-qlxy-01-k261673-cn--k261673)
- [MD-6000S Bladder Scanner (K260313): 510(k) cleared for MEDA Co., Ltd.](/report/fdapulse/md-6000s-bladder-scanner-k260313-cn--k260313)
- [Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON) (K260264): 510(k) cleared for Shanghai Medi Astro Technology Co., Ltd.](/report/fdapulse/medi-astro-total-and-partial-ossicular-prostheses-type-torp-cn--k260264)
- [Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (K254171): 510(k) cleared for Shenzhen Mericonn Technology Co., Ltd.](/report/fdapulse/mesh-nebulizer-un204-mesh-nebulizer-un205-mesh-nebulizer-cn--k254171)
- [Mobile Dental Solution (Model: DS50, DS70, DS90) (K260275): 510(k) cleared for Guangdong JINME Medical Technology Co., Ltd.](/report/fdapulse/mobile-dental-solution-model-cn--k260275)
- [MOBILITY SCOOTER (YQ-401,YQ- 401A,YQ-403,YQ-403A) (K262553): 510(k) cleared for Zhejiang Kailang Technology Co., Ltd.](/report/fdapulse/mobility-scooter-yq-401-yq-401a-yq-403-yq-403a-k262553-cn--k262553)
- [Mouth Guard (K262559): 510(k) cleared for ChangSha ChuangDuoLe E-Commerce Co., Ltd.](/report/fdapulse/mouth-guard-k262559-cn--k262559)
- [Multifunctional wheelchair (YJ-059) (K261919): 510(k) cleared for Zhenjiang Assure Medical Equipment Co., Ltd.](/report/fdapulse/multifunctional-wheelchair-yj-059-k261919-cn--k261919)
- [Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401) (K262822): 510(k) cleared for Zhongshan GL Electronics Co. , Ltd.](/report/fdapulse/nasal-aspirator-tlc-n02-electric-nosefrida-pro-12300400-cn--k262822)
- [NC PTA Balloon Dilatation Catheter (K254212): 510(k) cleared for Kossel Medtech (Suzhou) Co., Ltd.](/report/fdapulse/nc-pta-balloon-dilatation-catheter-k254212-cn--k254212)
- [Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo) (K261572): 510(k) cleared for Keyue (Hangzhou) Medical Information Technology Co., Ltd.](/report/fdapulse/nd-cn--k261572)
- [Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K260230): 510(k) cleared for Suzhou Medical Appliance Factory](/report/fdapulse/needle-stimulator-sdz-iib-sdz-iic-sdz-iii-sdz-v-k260230-cn--k260230)
- [Ninenovo Blood Oxygen Ring (BORMB-01-6,BORMB-01-7,BORMB-01-8,BORMB-01-9,BORMB-01-10,BORMB-01-11,BORMB-01-12,BORMB-01-13,BORMB-01-14) (K260490): 510(k) cleared for Shenzhen Ninenovo Technology Limited](/report/fdapulse/ninenovo-blood-oxygen-ring-bormb-01-6-bormb-01-7-bormb-01-8-cn--k260490)
- [PicoPeak Picosecond Nd:Yag Laser System (Bella-9) (K262701): 510(k) cleared for Beijing Sea Heart International Science and Technologyco.Ltd](/report/fdapulse/picopeak-picosecond-nd-cn--k262701)
- [Picosecond Laser treatment system (Z180) (K262628): 510(k) cleared for Sanhe PERFECTLASER Technology Co., Ltd.](/report/fdapulse/picosecond-laser-treatment-system-z180-k262628-cn--k262628)
- [Portable Oxygen Concentrator (OX-1A-E, OX-1B) (K254289): 510(k) cleared for Oxytek Medical Technology Co., Ltd.](/report/fdapulse/portable-oxygen-concentrator-ox-1a-e-ox-1b-k254289-cn--k254289)
- [Power Mobility Scooter (MA03) (K262213): 510(k) cleared for Nanjing Mijo Technology Co., Ltd.](/report/fdapulse/power-mobility-scooter-ma03-k262213-cn--k262213)
- [Power Wheelchair (D39) (K261169): 510(k) cleared for Anhui JBH Medical Apparatus Co., Ltd.](/report/fdapulse/power-wheelchair-d39-k261169-cn--k261169)
- [Power Wheelchair (D60) (K261200): 510(k) cleared for Anhui JBH Medical Apparatus Co., Ltd.](/report/fdapulse/power-wheelchair-d60-k261200-cn--k261200)
- [Power Wheelchair (DC12) (K261079): 510(k) cleared for Anhui JBH Medical Apparatus Co., Ltd.](/report/fdapulse/power-wheelchair-dc12-k261079-cn--k261079)
- [PV-iCurve Pro (K261531): 510(k) cleared for Perception Vision Medical Technology Co., Ltd.](/report/fdapulse/pv-icurve-pro-k261531-cn--k261531)
- [Reclining wheelchair (YJ-013L) (K260144): 510(k) cleared for Zhenjiang Assure Medical Equipment Co., Ltd.](/report/fdapulse/reclining-wheelchair-yj-013l-k260144-cn--k260144)
- [Rongjian Self-adhesive Electrode (K262664): 510(k) cleared for Bozhou Rongjian Medical Appliance Co., Ltd.](/report/fdapulse/rongjian-self-adhesive-electrode-k262664-cn--k262664)
- [Safety lancet (XL) (K262526): 510(k) cleared for Tianjin Huahong Technology Co., Ltd.](/report/fdapulse/safety-lancet-xl-k262526-cn--k262526)
- [Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B) (K262524): 510(k) cleared for ONE BEAUTY Technology Co., Ltd.](/report/fdapulse/sapphire-cooling-ipl-hair-removal-device-ice-2-0-ice-2-1-cn--k262524)
- [Single Use Ureteral Access Sheath (K260410): 510(k) cleared for Zhejiang Chuangxiang Medical Technology Co., Ltd.](/report/fdapulse/single-use-ureteral-access-sheath-k260410-cn--k260410)
- [Single-Use EBUS Balloon (K261616): 510(k) cleared for Micro-Tech (Nanjing) Co., Ltd.](/report/fdapulse/single-use-ebus-balloon-k261616-cn--k261616)
- [Single-use Flexible Bronchoscope (K261637): 510(k) cleared for Hunan Vathin Medical Instrument Co., Ltd.](/report/fdapulse/single-use-flexible-bronchoscope-k261637-cn--k261637)
- [Sterilization Cassette (CASS-1) (K262042): 510(k) cleared for Alliedstar Medical Equipment Co., Ltd.](/report/fdapulse/sterilization-cassette-cass-1-k262042-cn--k262042)
- [TECAR Therapy Device (TC2000, TC2001) (K252288): 510(k) cleared for Shenzhen Dongdixin Technology Co., Ltd.](/report/fdapulse/tecar-therapy-device-tc2000-tc2001-k252288-cn--k252288)
- [UV Phototherapy Device (KZX-308nm-BL65, KZX-308nm-BL55, KZX-308nm-BL50, KZX-308nm-BL45, KZX-308nm-BL35) (K262285): 510(k) cleared for Shijiazhuang Recovery Star Medical Device Co., Ltd.](/report/fdapulse/uv-phototherapy-device-kzx-308nm-bl65-kzx-308nm-bl55-kzx-cn--k262285)
- [VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System. (K260687): 510(k) cleared for Vivachek Biotech (Hangzhou) Co., Ltd.](/report/fdapulse/vivachek-blood-glucose-and-ketone-dual-ble-monitoring-cn--k260687)
- [Wearable Breast Pump (Model S36) (K254203): 510(k) cleared for Shenzhen TPH Technology Co., Ltd.](/report/fdapulse/wearable-breast-pump-model-s36-k254203-cn--k254203)
- [Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Reco](/report/fdapulse/wearable-ecg-recorder-ymheart-xy-12-wearable-ecg-recorder-cn--k254119)
- [Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) (K261574): 510(k) cleared for Hong Qiangxing (Shenzhen) Electronics Limited](/report/fdapulse/wireless-tens-and-ems-and-nmes-heating-stimulator-sm9086-cn--k261574)
- [YJ-K1K2 Wheelchair (YJ-013F) (K260145): 510(k) cleared for Zhenjiang Assure Medical Equipment Co., Ltd.](/report/fdapulse/yj-k1k2-wheelchair-yj-013f-k260145-cn--k260145)
- [ZYLOX Hippo PTA Balloon Dilatation Catheter (K260416): 510(k) cleared for Zylox Medtech Co., Ltd.](/report/fdapulse/zylox-hippo-pta-balloon-dilatation-catheter-k260416-cn--k260416)
- [Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter (K260686): 510(k) cleared for Zylox Medtech Co., Ltd.](/report/fdapulse/zylox-panflex-percutaneous-transluminal-angioplasty-scoring-cn--k260686)

## Colorado

- [APEX 3D S Diamond Tibia (K261120): 510(k) cleared for Paragon 28, Inc.](/report/fdapulse/apex-3d-s-diamond-tibia-k261120-co--k261120)
- [Class II recall Z-0194-2027: Medtronic Navigation, Inc.](/report/fdapulse/class-ii-recall-z-0194-2027-co--z-0194-2027)
- [Class II recall Z-0195-2027: Medtronic Navigation, Inc.](/report/fdapulse/class-ii-recall-z-0195-2027-co--z-0195-2027)
- [Class II recall Z-0196-2027: Medtronic Navigation, Inc.](/report/fdapulse/class-ii-recall-z-0196-2027-co--z-0196-2027)
- [Class II recall Z-0197-2027: Medtronic Navigation, Inc.](/report/fdapulse/class-ii-recall-z-0197-2027-co--z-0197-2027)
- [LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated (K261070): 510(k) cleared for Covidien, LLC](/report/fdapulse/ligasure-ras-maryland-jaw-vessel-sealer-divider-nano-coated-co--k261070)
- [Rapid ICH (v4.0) (K262301): 510(k) cleared for Ischemaview, Inc.](/report/fdapulse/rapid-ich-v4-0-k262301-co--k262301)
- [Rapid Platform (R6.7) (K261368): 510(k) cleared for Ischemaview, Inc.](/report/fdapulse/rapid-platform-r6-7-k261368-co--k261368)
- [TriSalus TriNav Advance Infusion System (K253509): 510(k) cleared for Trisalus Life Sciences](/report/fdapulse/trisalus-trinav-advance-infusion-system-k253509-co--k253509)

## Connecticut

- [Class I recall Z-3140-2026: CooperSurgical, Inc.](/report/fdapulse/class-i-recall-z-3140-2026-ct--z-3140-2026)
- [Class II recall Z-0147-2027: INTEGRATED MEDCRAFT LLC](/report/fdapulse/class-ii-recall-z-0147-2027-ct--z-0147-2027)

## Delaware

- [Actolind® (06.3637. Actolind® Gel Plus) (K254168): 510(k) cleared for ACTO GmbH](/report/fdapulse/actolind-06-3637-actolind-gel-plus-k254168-de--k254168)
- [ANTERION (K261019): 510(k) cleared for Heidelberg Engineering GmbH](/report/fdapulse/anterion-k261019-de--k261019)
- [B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC (K260302): 510(k) cleared for B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific)](/report/fdapulse/b-r-a-h-m-s-mr-proadm-kryptor-b-r-a-h-m-s-mr-proadm-kryptor-de--k260302)
- [Cerclage Wires;K-wires;Steinmann Pins (K262126): 510(k) cleared for MK Medical GmbH](/report/fdapulse/cerclage-wires-k-wires-steinmann-pins-k262126-de--k262126)
- [CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS) (K254299): 510(k) cleared for Karl Storz SE & CO. KG](/report/fdapulse/clearvision-irrigation-sheath-0-7241as-clearvision-de--k254299)
- [colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) (K253481): 510(k) cleared for Ovesco Endoscopy AG](/report/fdapulse/colonic-ftrd-set-200-70-diagnostic-ftrd-set-200-76-de--k253481)
- [danumed StomaMeter (K262038): 510(k) cleared for Danumed Medizintechnik GmbH](/report/fdapulse/danumed-stomameter-k262038-de--k262038)
- [Disposable Belts for Polysomnography (CNSAC) (K260949): 510(k) cleared for CNSAC Medshop GmbH](/report/fdapulse/disposable-belts-for-polysomnography-cnsac-k260949-de--k260949)
- [Eden PACS (K261788): 510(k) cleared for Higia., Inc. d/b/a Eden](/report/fdapulse/eden-pacs-k261788-de--k261788)
- [Endox High Level Disinfectant (K254094): 510(k) cleared for Whiteley USA, Inc.](/report/fdapulse/endox-high-level-disinfectant-k254094-de--k254094)
- [Hygienic Protective Bite Cover (2207-010-50) (K262073): 510(k) cleared for Dürr Dental SE](/report/fdapulse/hygienic-protective-bite-cover-2207-010-50-k262073-de--k262073)
- [ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (K263010): 510(k) cleared for inomed Medizintechnik GmbH](/report/fdapulse/isis-headboxes-isis-neurostimulator-isis-xpert-plus-isis-de--k263010)
- [KARL STORZ Flexible Video Neuro-Endoscope (K260581): 510(k) cleared for Karl Storz SE & CO. KG](/report/fdapulse/karl-storz-flexible-video-neuro-endoscope-k260581-de--k260581)
- [KARL STORZ SUPRALOOP (K254303): 510(k) cleared for Karl Storz SE & CO. KG](/report/fdapulse/karl-storz-supraloop-k254303-de--k254303)
- [KARL STORZ TIPCAM1 Rubina (K262547): 510(k) cleared for KALR STORZ SE & Co. KG](/report/fdapulse/karl-storz-tipcam1-rubina-k262547-de--k262547)
- [QIAstat-Dx BCID GN Plus AMR Panel (K262168): 510(k) cleared for QIAGEN GmbH](/report/fdapulse/qiastat-dx-bcid-gn-plus-amr-panel-k262168-de--k262168)
- [RT Elements (4.6) (K261655): 510(k) cleared for Brainlab SE](/report/fdapulse/rt-elements-4-6-k261655-de--k261655)
- [Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine (K262257): 510(k) cleared for Brainlab SE](/report/fdapulse/spine-planning-3-0-spine-and-trauma-navigation-alignment-de--k262257)
- [stentFIX System Set (100.50n) (K260487): 510(k) cleared for Ovesco Endoscopy AG](/report/fdapulse/stentfix-system-set-100-50n-k260487-de--k260487)
- [Syngo Carbon Space (VA4) (K263048): 510(k) cleared for Siemens Healthineers AG](/report/fdapulse/syngo-carbon-space-va4-k263048-de--k263048)
- [THERMEO® I MSI (K260031): 510(k) cleared for Pro3Dure Medical GmbH](/report/fdapulse/thermeo-i-msi-k260031-de--k260031)
- [Tontarra Punches and Rongeurs (K260446): 510(k) cleared for Tontarra Medizintechnik GmbH](/report/fdapulse/tontarra-punches-and-rongeurs-k260446-de--k260446)
- [TORUS Ultrasonic Aspirator System; and accessories (TORUS Single-Use Tubing Sets, TORUS Single-Use Torque Wrenches, TORUS Handpieces, TORUS Tip Packs, TORUS Tip Clearing Stylet) (K261361): 510(k) cleared for Carl Zeiss Meditec, AG](/report/fdapulse/torus-ultrasonic-aspirator-system-and-accessories-torus-de--k261361)
- [UNIDRIVE Select System (K261102): 510(k) cleared for Karl Storz SE & CO. KG](/report/fdapulse/unidrive-select-system-k261102-de--k261102)
- [UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10) (K254252): 510(k) cleared for Karl Storz SE & CO. KG](/report/fdapulse/unidrive-siii-system-hopkins-telescope-0o-26205ama-de--k254252)

## DK

- [Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set (K260309): 510(k) cleared for Ambu A/S](/report/fdapulse/ambu-ascope-5-broncho-2-7-1-2-ambu-ascope-5-broncho-4-2-2-2-dk--k260309)
- [Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large (K261400): 510(k) cleared for Ambu A/S](/report/fdapulse/ambu-ascope-gastro-ambu-ascope-gastro-large-k261400-dk--k261400)
- [BoneXpert (K262390): 510(k) cleared for Visiana](/report/fdapulse/bonexpert-k262390-dk--k262390)
- [Elos Accurate Hybrid Base (K261327): 510(k) cleared for Elos Medtech Pinol A/S](/report/fdapulse/elos-accurate-hybrid-base-k261327-dk--k261327)

## ES

- [KIM BLUE (K262284): 510(k) cleared for Desarrollo e Investigación Médica Aragonesa S.L.](/report/fdapulse/kim-blue-k262284-es--k262284)

## Florida

- [Arthrex Beaming System (K262975): 510(k) cleared for Arthrex, Inc.](/report/fdapulse/arthrex-beaming-system-k262975-fl--k262975)
- [Arthrex Spine Compression FT Screw (K262618): 510(k) cleared for Arthrex, Inc.](/report/fdapulse/arthrex-spine-compression-ft-screw-k262618-fl--k262618)
- [BellaTek Bars (K260940): 510(k) cleared for ZimVie US Corp, LLC](/report/fdapulse/bellatek-bars-k260940-fl--k260940)
- [Class II recall Z-0160-2027: Beckman Coulter, Inc.](/report/fdapulse/class-ii-recall-z-0160-2027-fl--z-0160-2027)
- [Class II recall Z-0161-2027: Beckman Coulter, Inc.](/report/fdapulse/class-ii-recall-z-0161-2027-fl--z-0161-2027)
- [Durashield Device Kit (K252995): 510(k) cleared for SurGenTec, LLC](/report/fdapulse/durashield-device-kit-k252995-fl--k252995)
- [epi-ConneKt™ Wound Matrix (K260530): 510(k) cleared for MLM Biologics, Inc.](/report/fdapulse/epi-connekt-wound-matrix-k260530-fl--k260530)
- [Hemotag Analysis Software (HAS) (K252736): 510(k) cleared for Aventusoft, LLC](/report/fdapulse/hemotag-analysis-software-has-k252736-fl--k252736)
- [Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) (K243223): 510(k) cleared for Bh Group Us, LLC](/report/fdapulse/multiple-therapy-aesthetic-treatment-device-bhs-202-unyque-fl--k243223)
- [NeuroDR (K262134): 510(k) cleared for Deep Reasoning Ai, Inc.](/report/fdapulse/neurodr-k262134-fl--k262134)
- [Response Ortho Smart Fixator - Hexapod System (K263083): 510(k) cleared for Response Ortho Solutions, LLC](/report/fdapulse/response-ortho-smart-fixator-hexapod-system-k263083-fl--k263083)
- [RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology (K262193): 510(k) cleared for Xenix Medical](/report/fdapulse/riva-posterior-fixation-system-with-nanoactiv-surface-fl--k262193)
- [Sleep Analysis Module (K261521): 510(k) cleared for Neurotronics, LLC](/report/fdapulse/sleep-analysis-module-k261521-fl--k261521)
- [TMC Implant Fixation System (K262963): 510(k) cleared for Treace Medical Concepts, Inc.](/report/fdapulse/tmc-implant-fixation-system-k262963-fl--k262963)
- [Vantage Lumbar Decompression Kit (K263208): 510(k) cleared for SurGenTec, LLC](/report/fdapulse/vantage-lumbar-decompression-kit-k263208-fl--k263208)
- [Yomi S Robotic System (K261321): 510(k) cleared for Neocis, Inc.](/report/fdapulse/yomi-s-robotic-system-k261321-fl--k261321)

## FR

- [Alians Forearm (K262649): 510(k) cleared for Newclip Technics](/report/fdapulse/alians-forearm-k262649-fr--k262649)
- [CINA-Aneurysm (K262062): 510(k) cleared for Avicenna.Ai](/report/fdapulse/cina-aneurysm-k262062-fr--k262062)
- [CINA-Aneurysm+ (K262147): 510(k) cleared for Avicenna.Ai](/report/fdapulse/cina-aneurysm-k262147-fr--k262147)
- [F.A.S.T Screw (K254280): 510(k) cleared for Steps Ortho](/report/fdapulse/f-a-s-t-screw-k254280-fr--k254280)
- [Transorb™ Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030) (K262443): 510(k) cleared for Sofradim Production](/report/fdapulse/transorb-self-gripping-resorbable-mesh-tsb1510-tsb2020-fr--k262443)
- [Yumizen H550 (K260781): 510(k) cleared for HORIBA ABX SAS](/report/fdapulse/yumizen-h550-k260781-fr--k260781)

## GB

- [Braun Aura 7 (6041) (K261975): 510(k) cleared for CyDen Limited](/report/fdapulse/braun-aura-7-6041-k261975-gb--k261975)
- [Braun Aura 9 (6042) (K261977): 510(k) cleared for Cyden Limited](/report/fdapulse/braun-aura-9-6042-k261977-gb--k261977)
- [CADDIE (K260133): 510(k) cleared for Odin Medical Limited](/report/fdapulse/caddie-k260133-gb--k260133)
- [iOS CamAPS FX (K261896): 510(k) cleared for CamDiab](/report/fdapulse/ios-camaps-fx-k261896-gb--k261896)
- [RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747) (K261982): 510(k) cleared for Smith & Nephew Medical, Ltd.](/report/fdapulse/renasys-abdo-shield-temporary-abdominal-closure-kit-gb--k261982)
- [STAR Apollo™ Mapping System (K263380): 510(k) cleared for Rhythm AI, Ltd.](/report/fdapulse/star-apollo-mapping-system-k263380-gb--k263380)
- [Unity Total Knee System, Unity Knee Cementless CR Femur (K261275): 510(k) cleared for Corin, Ltd.](/report/fdapulse/unity-total-knee-system-unity-knee-cementless-cr-femur-gb--k261275)
- [Versius Surgical System (Versius Plus) (K261252): 510(k) cleared for Cmr Surgical Limited](/report/fdapulse/versius-surgical-system-versius-plus-k261252-gb--k261252)

## Georgia

- [B. anthracis Real-time PCR Assay (K262368): 510(k) cleared for Centers for Disease Control and Prevention](/report/fdapulse/b-anthracis-real-time-pcr-assay-k262368-ga--k262368)
- [CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit) (K263035): 510(k) cleared for Centers for Disease Control and Prevention](/report/fdapulse/cdc-human-influenza-virus-real-time-rt-pcr-diagnostic-panel-ga--k263035)
- [Class II recall Z-0003-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0003-2027-ga--z-0003-2027)
- [Class II recall Z-0004-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0004-2027-ga--z-0004-2027)
- [Class II recall Z-0005-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0005-2027-ga--z-0005-2027)
- [Class II recall Z-0006-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0006-2027-ga--z-0006-2027)
- [Class II recall Z-0007-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0007-2027-ga--z-0007-2027)
- [Class II recall Z-0008-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0008-2027-ga--z-0008-2027)
- [Class II recall Z-0009-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0009-2027-ga--z-0009-2027)
- [Class II recall Z-0010-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0010-2027-ga--z-0010-2027)
- [Class II recall Z-0011-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0011-2027-ga--z-0011-2027)
- [Class II recall Z-0012-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0012-2027-ga--z-0012-2027)
- [Class II recall Z-0013-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0013-2027-ga--z-0013-2027)
- [Class II recall Z-0014-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0014-2027-ga--z-0014-2027)
- [Class II recall Z-0015-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0015-2027-ga--z-0015-2027)
- [Class II recall Z-0016-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0016-2027-ga--z-0016-2027)
- [Class II recall Z-0017-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0017-2027-ga--z-0017-2027)
- [Class II recall Z-0018-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0018-2027-ga--z-0018-2027)
- [Class II recall Z-0019-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0019-2027-ga--z-0019-2027)
- [Class II recall Z-0020-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0020-2027-ga--z-0020-2027)
- [Class II recall Z-0021-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0021-2027-ga--z-0021-2027)
- [Class II recall Z-0022-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0022-2027-ga--z-0022-2027)
- [Class II recall Z-0023-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0023-2027-ga--z-0023-2027)
- [Class II recall Z-0024-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0024-2027-ga--z-0024-2027)
- [Class II recall Z-0025-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0025-2027-ga--z-0025-2027)
- [Class II recall Z-0026-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0026-2027-ga--z-0026-2027)
- [Class II recall Z-0027-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0027-2027-ga--z-0027-2027)
- [Class II recall Z-0028-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0028-2027-ga--z-0028-2027)
- [Class II recall Z-0029-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0029-2027-ga--z-0029-2027)
- [Class II recall Z-0030-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0030-2027-ga--z-0030-2027)
- [Class II recall Z-0031-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0031-2027-ga--z-0031-2027)
- [Class II recall Z-0032-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0032-2027-ga--z-0032-2027)
- [Class II recall Z-0033-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0033-2027-ga--z-0033-2027)
- [Class II recall Z-0034-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0034-2027-ga--z-0034-2027)
- [Class II recall Z-0035-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0035-2027-ga--z-0035-2027)
- [Class II recall Z-0036-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0036-2027-ga--z-0036-2027)
- [Class II recall Z-0037-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0037-2027-ga--z-0037-2027)
- [Class II recall Z-0038-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0038-2027-ga--z-0038-2027)
- [Class II recall Z-0039-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0039-2027-ga--z-0039-2027)
- [Class II recall Z-0040-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0040-2027-ga--z-0040-2027)
- [Class II recall Z-0041-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0041-2027-ga--z-0041-2027)
- [Class II recall Z-0042-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0042-2027-ga--z-0042-2027)
- [Class II recall Z-0043-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0043-2027-ga--z-0043-2027)
- [Class II recall Z-0044-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0044-2027-ga--z-0044-2027)
- [Class II recall Z-0045-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0045-2027-ga--z-0045-2027)
- [Class II recall Z-0046-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0046-2027-ga--z-0046-2027)
- [Class II recall Z-0047-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0047-2027-ga--z-0047-2027)
- [Class II recall Z-0048-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0048-2027-ga--z-0048-2027)
- [Class II recall Z-0049-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0049-2027-ga--z-0049-2027)
- [Class II recall Z-0050-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0050-2027-ga--z-0050-2027)
- [Class II recall Z-0051-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0051-2027-ga--z-0051-2027)
- [Class II recall Z-0052-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0052-2027-ga--z-0052-2027)
- [Class II recall Z-0053-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0053-2027-ga--z-0053-2027)
- [Class II recall Z-0054-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0054-2027-ga--z-0054-2027)
- [Class II recall Z-0055-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0055-2027-ga--z-0055-2027)
- [Class II recall Z-0056-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0056-2027-ga--z-0056-2027)
- [Class II recall Z-0057-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0057-2027-ga--z-0057-2027)
- [Class II recall Z-0058-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0058-2027-ga--z-0058-2027)
- [Class II recall Z-0059-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0059-2027-ga--z-0059-2027)
- [Class II recall Z-0060-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0060-2027-ga--z-0060-2027)
- [Class II recall Z-0061-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0061-2027-ga--z-0061-2027)
- [Class II recall Z-0062-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0062-2027-ga--z-0062-2027)
- [Class II recall Z-0063-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0063-2027-ga--z-0063-2027)
- [Class II recall Z-0064-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0064-2027-ga--z-0064-2027)
- [Class II recall Z-0065-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0065-2027-ga--z-0065-2027)
- [Class II recall Z-0066-2027: ASP Global, LLC.](/report/fdapulse/class-ii-recall-z-0066-2027-ga--z-0066-2027)
- [CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test (K262432): 510(k) cleared for CorDx, Inc.](/report/fdapulse/cordx-tyfast-flu-a-b-and-covid-19-at-home-multiplex-rapid-ga--k262432)
- [DynaNail Helix® Fixation System (K260995): 510(k) cleared for MedShape, Inc.](/report/fdapulse/dynanail-helix-fixation-system-k260995-ga--k260995)
- [OAB Delivery Catheter (K253422): 510(k) cleared for Cognition Medical Corp.](/report/fdapulse/oab-delivery-catheter-k253422-ga--k253422)

## HU

- [Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension Kit 1 (UL-800-Shape-Ext-Kit-1);Ultimate Shape Extension Kit 2 (UL-800-Shape-Ext-Kit-2) (K260945): 510(k) cleared for Fit-Pro KFT (Ltd.) - DBA E-Fit](/report/fdapulse/ultima-system-ul-800-ultimate-face-package-ul-800-face-set-hu--k260945)

## Idaho

- [Class II recall Z-3319-2026: Percussionaire Corporation](/report/fdapulse/class-ii-recall-z-3319-2026-id--z-3319-2026)
- [Class II recall Z-3320-2026: Percussionaire Corporation](/report/fdapulse/class-ii-recall-z-3320-2026-id--z-3320-2026)
- [Class II recall Z-3321-2026: Percussionaire Corporation](/report/fdapulse/class-ii-recall-z-3321-2026-id--z-3321-2026)
- [Class II recall Z-3322-2026: Percussionaire Corporation](/report/fdapulse/class-ii-recall-z-3322-2026-id--z-3322-2026)
- [Class II recall Z-3323-2026: Percussionaire Corporation](/report/fdapulse/class-ii-recall-z-3323-2026-id--z-3323-2026)
- [Class II recall Z-3324-2026: Percussionaire Corporation](/report/fdapulse/class-ii-recall-z-3324-2026-id--z-3324-2026)
- [Class II recall Z-3325-2026: Percussionaire Corporation](/report/fdapulse/class-ii-recall-z-3325-2026-id--z-3325-2026)

## IE

- [Liquick X-treme, Liquick X-treme Plus (K261418): 510(k) cleared for Teleflex Medical](/report/fdapulse/liquick-x-treme-liquick-x-treme-plus-k261418-ie--k261418)

## Illinois

- [Anti-HCV Next (K262156): 510(k) cleared for Abbott Laboratories](/report/fdapulse/anti-hcv-next-k262156-il--k262156)
- [CarboClear® Cervical Navigated Instruments (K263154): 510(k) cleared for CarboFix Orhtopedics , Ltd.](/report/fdapulse/carboclear-cervical-navigated-instruments-k263154-il--k263154)
- [Class I recall Z-3227-2026: Medline Industries, LP](/report/fdapulse/class-i-recall-z-3227-2026-il--z-3227-2026)
- [Class I recall Z-3228-2026: Medline Industries, LP](/report/fdapulse/class-i-recall-z-3228-2026-il--z-3228-2026)
- [Class II recall Z-0079-2027: Cardinal Health 200, LLC](/report/fdapulse/class-ii-recall-z-0079-2027-il--z-0079-2027)
- [Class II recall Z-0086-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0086-2027-il--z-0086-2027)
- [Class II recall Z-0087-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0087-2027-il--z-0087-2027)
- [Class II recall Z-0151-2027: Baxter Healthcare Corporation](/report/fdapulse/class-ii-recall-z-0151-2027-il--z-0151-2027)
- [Class II recall Z-0168-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0168-2027-il--z-0168-2027)

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