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.

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.
• JADE SCORE PTA Scoring Balloon Dilatation Catheter (K261778): 510(k) cleared for OrbusNeich Medical (Shenzhen) Co., Ltd.
• 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.
• LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) (K261370): 510(k) cleared for Guangdong Newdermo Biotech Co., Ltd.
• LED Therapy Device (QLXY-01) (K261673): 510(k) cleared for Beijing Nubway S&T Co., Ltd.
• MD-6000S Bladder Scanner (K260313): 510(k) cleared for MEDA Co., Ltd.
• 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.
• Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (K254171): 510(k) cleared for Shenzhen Mericonn Technology Co., Ltd.
• Mobile Dental Solution (Model: DS50, DS70, DS90) (K260275): 510(k) cleared for Guangdong JINME Medical Technology Co., Ltd.
• MOBILITY SCOOTER (YQ-401,YQ- 401A,YQ-403,YQ-403A) (K262553): 510(k) cleared for Zhejiang Kailang Technology Co., Ltd.
• Mouth Guard (K262559): 510(k) cleared for ChangSha ChuangDuoLe E-Commerce Co., Ltd.
• Multifunctional wheelchair (YJ-059) (K261919): 510(k) cleared for Zhenjiang Assure Medical Equipment Co., Ltd.
• Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401) (K262822): 510(k) cleared for Zhongshan GL Electronics Co. , Ltd.
• NC PTA Balloon Dilatation Catheter (K254212): 510(k) cleared for Kossel Medtech (Suzhou) Co., Ltd.
• Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo) (K261572): 510(k) cleared for Keyue (Hangzhou) Medical Information Technology Co., Ltd.
• Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K260230): 510(k) cleared for Suzhou Medical Appliance Factory
• 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
• PicoPeak Picosecond Nd:Yag Laser System (Bella-9) (K262701): 510(k) cleared for Beijing Sea Heart International Science and Technologyco.Ltd
• Picosecond Laser treatment system (Z180) (K262628): 510(k) cleared for Sanhe PERFECTLASER Technology Co., Ltd.
• Portable Oxygen Concentrator (OX-1A-E, OX-1B) (K254289): 510(k) cleared for Oxytek Medical Technology Co., Ltd.
• Power Mobility Scooter (MA03) (K262213): 510(k) cleared for Nanjing Mijo Technology Co., Ltd.
• Power Wheelchair (D39) (K261169): 510(k) cleared for Anhui JBH Medical Apparatus Co., Ltd.
• Power Wheelchair (D60) (K261200): 510(k) cleared for Anhui JBH Medical Apparatus Co., Ltd.
• Power Wheelchair (DC12) (K261079): 510(k) cleared for Anhui JBH Medical Apparatus Co., Ltd.
• PV-iCurve Pro (K261531): 510(k) cleared for Perception Vision Medical Technology Co., Ltd.
• Reclining wheelchair (YJ-013L) (K260144): 510(k) cleared for Zhenjiang Assure Medical Equipment Co., Ltd.
• Rongjian Self-adhesive Electrode (K262664): 510(k) cleared for Bozhou Rongjian Medical Appliance Co., Ltd.
• Safety lancet (XL) (K262526): 510(k) cleared for Tianjin Huahong Technology Co., Ltd.
• 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.
• Single Use Ureteral Access Sheath (K260410): 510(k) cleared for Zhejiang Chuangxiang Medical Technology Co., Ltd.
• Single-Use EBUS Balloon (K261616): 510(k) cleared for Micro-Tech (Nanjing) Co., Ltd.
• Single-use Flexible Bronchoscope (K261637): 510(k) cleared for Hunan Vathin Medical Instrument Co., Ltd.
• Sterilization Cassette (CASS-1) (K262042): 510(k) cleared for Alliedstar Medical Equipment Co., Ltd.
• TECAR Therapy Device (TC2000, TC2001) (K252288): 510(k) cleared for Shenzhen Dongdixin Technology Co., Ltd.
• 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.
• 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.
• Wearable Breast Pump (Model S36) (K254203): 510(k) cleared for Shenzhen TPH Technology Co., Ltd.
• 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
• Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) (K261574): 510(k) cleared for Hong Qiangxing (Shenzhen) Electronics Limited
• YJ-K1K2 Wheelchair (YJ-013F) (K260145): 510(k) cleared for Zhenjiang Assure Medical Equipment Co., Ltd.
• ZYLOX Hippo PTA Balloon Dilatation Catheter (K260416): 510(k) cleared for Zylox Medtech Co., Ltd.
• Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter (K260686): 510(k) cleared for Zylox Medtech Co., Ltd.

Colorado

• APEX 3D S Diamond Tibia (K261120): 510(k) cleared for Paragon 28, Inc.
• Class II recall Z-0194-2027: Medtronic Navigation, Inc.
• Class II recall Z-0195-2027: Medtronic Navigation, Inc.
• Class II recall Z-0196-2027: Medtronic Navigation, Inc.
• Class II recall Z-0197-2027: Medtronic Navigation, Inc.
• LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated (K261070): 510(k) cleared for Covidien, LLC
• Rapid ICH (v4.0) (K262301): 510(k) cleared for Ischemaview, Inc.
• Rapid Platform (R6.7) (K261368): 510(k) cleared for Ischemaview, Inc.
• TriSalus TriNav Advance Infusion System (K253509): 510(k) cleared for Trisalus Life Sciences

Connecticut

• Class I recall Z-3140-2026: CooperSurgical, Inc.
• Class II recall Z-0147-2027: INTEGRATED MEDCRAFT LLC

Delaware

• Actolind® (06.3637. Actolind® Gel Plus) (K254168): 510(k) cleared for ACTO GmbH
• ANTERION (K261019): 510(k) cleared for Heidelberg Engineering GmbH
• 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)
• Cerclage Wires;K-wires;Steinmann Pins (K262126): 510(k) cleared for MK Medical GmbH
• 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
• colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) (K253481): 510(k) cleared for Ovesco Endoscopy AG
• danumed StomaMeter (K262038): 510(k) cleared for Danumed Medizintechnik GmbH
• Disposable Belts for Polysomnography (CNSAC) (K260949): 510(k) cleared for CNSAC Medshop GmbH
• Eden PACS (K261788): 510(k) cleared for Higia., Inc. d/b/a Eden
• Endox High Level Disinfectant (K254094): 510(k) cleared for Whiteley USA, Inc.
• Hygienic Protective Bite Cover (2207-010-50) (K262073): 510(k) cleared for Dürr Dental SE
• ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (K263010): 510(k) cleared for inomed Medizintechnik GmbH
• KARL STORZ Flexible Video Neuro-Endoscope (K260581): 510(k) cleared for Karl Storz SE & CO. KG
• KARL STORZ SUPRALOOP (K254303): 510(k) cleared for Karl Storz SE & CO. KG
• KARL STORZ TIPCAM1 Rubina (K262547): 510(k) cleared for KALR STORZ SE & Co. KG
• QIAstat-Dx BCID GN Plus AMR Panel (K262168): 510(k) cleared for QIAGEN GmbH
• RT Elements (4.6) (K261655): 510(k) cleared for Brainlab SE
• Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine (K262257): 510(k) cleared for Brainlab SE
• stentFIX System Set (100.50n) (K260487): 510(k) cleared for Ovesco Endoscopy AG
• Syngo Carbon Space (VA4) (K263048): 510(k) cleared for Siemens Healthineers AG
• THERMEO® I MSI (K260031): 510(k) cleared for Pro3Dure Medical GmbH
• Tontarra Punches and Rongeurs (K260446): 510(k) cleared for Tontarra Medizintechnik GmbH
• 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
• UNIDRIVE Select System (K261102): 510(k) cleared for Karl Storz SE & CO. KG
• 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

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
• Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large (K261400): 510(k) cleared for Ambu A/S
• BoneXpert (K262390): 510(k) cleared for Visiana
• Elos Accurate Hybrid Base (K261327): 510(k) cleared for Elos Medtech Pinol A/S

ES

• KIM BLUE (K262284): 510(k) cleared for Desarrollo e Investigación Médica Aragonesa S.L.

Florida

• Arthrex Beaming System (K262975): 510(k) cleared for Arthrex, Inc.
• Arthrex Spine Compression FT Screw (K262618): 510(k) cleared for Arthrex, Inc.
• BellaTek Bars (K260940): 510(k) cleared for ZimVie US Corp, LLC
• Class II recall Z-0160-2027: Beckman Coulter, Inc.
• Class II recall Z-0161-2027: Beckman Coulter, Inc.
• Durashield Device Kit (K252995): 510(k) cleared for SurGenTec, LLC
• epi-ConneKt™ Wound Matrix (K260530): 510(k) cleared for MLM Biologics, Inc.
• Hemotag Analysis Software (HAS) (K252736): 510(k) cleared for Aventusoft, LLC
• Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) (K243223): 510(k) cleared for Bh Group Us, LLC
• NeuroDR (K262134): 510(k) cleared for Deep Reasoning Ai, Inc.
• Response Ortho Smart Fixator - Hexapod System (K263083): 510(k) cleared for Response Ortho Solutions, LLC
• RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology (K262193): 510(k) cleared for Xenix Medical
• Sleep Analysis Module (K261521): 510(k) cleared for Neurotronics, LLC
• TMC Implant Fixation System (K262963): 510(k) cleared for Treace Medical Concepts, Inc.
• Vantage Lumbar Decompression Kit (K263208): 510(k) cleared for SurGenTec, LLC
• Yomi S Robotic System (K261321): 510(k) cleared for Neocis, Inc.

FR

• Alians Forearm (K262649): 510(k) cleared for Newclip Technics
• CINA-Aneurysm (K262062): 510(k) cleared for Avicenna.Ai
• CINA-Aneurysm+ (K262147): 510(k) cleared for Avicenna.Ai
• F.A.S.T Screw (K254280): 510(k) cleared for Steps Ortho
• Transorb™ Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030) (K262443): 510(k) cleared for Sofradim Production
• Yumizen H550 (K260781): 510(k) cleared for HORIBA ABX SAS

GB

• Braun Aura 7 (6041) (K261975): 510(k) cleared for CyDen Limited
• Braun Aura 9 (6042) (K261977): 510(k) cleared for Cyden Limited
• CADDIE (K260133): 510(k) cleared for Odin Medical Limited
• iOS CamAPS FX (K261896): 510(k) cleared for CamDiab
• RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747) (K261982): 510(k) cleared for Smith & Nephew Medical, Ltd.
• STAR Apollo™ Mapping System (K263380): 510(k) cleared for Rhythm AI, Ltd.
• Unity Total Knee System, Unity Knee Cementless CR Femur (K261275): 510(k) cleared for Corin, Ltd.
• Versius Surgical System (Versius Plus) (K261252): 510(k) cleared for Cmr Surgical Limited

Georgia

• B. anthracis Real-time PCR Assay (K262368): 510(k) cleared for Centers for Disease Control and Prevention
• 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
• Class II recall Z-0003-2027: ASP Global, LLC.
• Class II recall Z-0004-2027: ASP Global, LLC.
• Class II recall Z-0005-2027: ASP Global, LLC.
• Class II recall Z-0006-2027: ASP Global, LLC.
• Class II recall Z-0007-2027: ASP Global, LLC.
• Class II recall Z-0008-2027: ASP Global, LLC.
• Class II recall Z-0009-2027: ASP Global, LLC.
• Class II recall Z-0010-2027: ASP Global, LLC.
• Class II recall Z-0011-2027: ASP Global, LLC.
• Class II recall Z-0012-2027: ASP Global, LLC.
• Class II recall Z-0013-2027: ASP Global, LLC.
• Class II recall Z-0014-2027: ASP Global, LLC.
• Class II recall Z-0015-2027: ASP Global, LLC.
• Class II recall Z-0016-2027: ASP Global, LLC.
• Class II recall Z-0017-2027: ASP Global, LLC.
• Class II recall Z-0018-2027: ASP Global, LLC.
• Class II recall Z-0019-2027: ASP Global, LLC.
• Class II recall Z-0020-2027: ASP Global, LLC.
• Class II recall Z-0021-2027: ASP Global, LLC.
• Class II recall Z-0022-2027: ASP Global, LLC.
• Class II recall Z-0023-2027: ASP Global, LLC.
• Class II recall Z-0024-2027: ASP Global, LLC.
• Class II recall Z-0025-2027: ASP Global, LLC.
• Class II recall Z-0026-2027: ASP Global, LLC.
• Class II recall Z-0027-2027: ASP Global, LLC.
• Class II recall Z-0028-2027: ASP Global, LLC.
• Class II recall Z-0029-2027: ASP Global, LLC.
• Class II recall Z-0030-2027: ASP Global, LLC.
• Class II recall Z-0031-2027: ASP Global, LLC.
• Class II recall Z-0032-2027: ASP Global, LLC.
• Class II recall Z-0033-2027: ASP Global, LLC.
• Class II recall Z-0034-2027: ASP Global, LLC.
• Class II recall Z-0035-2027: ASP Global, LLC.
• Class II recall Z-0036-2027: ASP Global, LLC.
• Class II recall Z-0037-2027: ASP Global, LLC.
• Class II recall Z-0038-2027: ASP Global, LLC.
• Class II recall Z-0039-2027: ASP Global, LLC.
• Class II recall Z-0040-2027: ASP Global, LLC.
• Class II recall Z-0041-2027: ASP Global, LLC.
• Class II recall Z-0042-2027: ASP Global, LLC.
• Class II recall Z-0043-2027: ASP Global, LLC.
• Class II recall Z-0044-2027: ASP Global, LLC.
• Class II recall Z-0045-2027: ASP Global, LLC.
• Class II recall Z-0046-2027: ASP Global, LLC.
• Class II recall Z-0047-2027: ASP Global, LLC.
• Class II recall Z-0048-2027: ASP Global, LLC.
• Class II recall Z-0049-2027: ASP Global, LLC.
• Class II recall Z-0050-2027: ASP Global, LLC.
• Class II recall Z-0051-2027: ASP Global, LLC.
• Class II recall Z-0052-2027: ASP Global, LLC.
• Class II recall Z-0053-2027: ASP Global, LLC.
• Class II recall Z-0054-2027: ASP Global, LLC.
• Class II recall Z-0055-2027: ASP Global, LLC.
• Class II recall Z-0056-2027: ASP Global, LLC.
• Class II recall Z-0057-2027: ASP Global, LLC.
• Class II recall Z-0058-2027: ASP Global, LLC.
• Class II recall Z-0059-2027: ASP Global, LLC.
• Class II recall Z-0060-2027: ASP Global, LLC.
• Class II recall Z-0061-2027: ASP Global, LLC.
• Class II recall Z-0062-2027: ASP Global, LLC.
• Class II recall Z-0063-2027: ASP Global, LLC.
• Class II recall Z-0064-2027: ASP Global, LLC.
• Class II recall Z-0065-2027: ASP Global, LLC.
• Class II recall Z-0066-2027: ASP Global, LLC.
• 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.
• DynaNail Helix® Fixation System (K260995): 510(k) cleared for MedShape, Inc.
• OAB Delivery Catheter (K253422): 510(k) cleared for Cognition Medical Corp.

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

Idaho

• Class II recall Z-3319-2026: Percussionaire Corporation
• Class II recall Z-3320-2026: Percussionaire Corporation
• Class II recall Z-3321-2026: Percussionaire Corporation
• Class II recall Z-3322-2026: Percussionaire Corporation
• Class II recall Z-3323-2026: Percussionaire Corporation
• Class II recall Z-3324-2026: Percussionaire Corporation
• Class II recall Z-3325-2026: Percussionaire Corporation

IE

• Liquick X-treme, Liquick X-treme Plus (K261418): 510(k) cleared for Teleflex Medical

Illinois

• Anti-HCV Next (K262156): 510(k) cleared for Abbott Laboratories
• CarboClear® Cervical Navigated Instruments (K263154): 510(k) cleared for CarboFix Orhtopedics , Ltd.
• Class I recall Z-3227-2026: Medline Industries, LP
• Class I recall Z-3228-2026: Medline Industries, LP
• Class II recall Z-0079-2027: Cardinal Health 200, LLC
• Class II recall Z-0086-2027: Medline Industries, LP
• Class II recall Z-0087-2027: Medline Industries, LP
• Class II recall Z-0151-2027: Baxter Healthcare Corporation
• Class II recall Z-0168-2027: Medline Industries, LP

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