| S-Patch CardioAI (K254255): 510(k) cleared for Wellysis Corp. | Cardiovascular | 510(k) | 2026-09-25 |
| syngo.CT Brain Quantification (K260055): 510(k) cleared for Siemens Medical Solutions USA, Inc. | Radiology | 510(k) | 2026-09-25 |
| Tempus ECG-MR (K254297): 510(k) cleared for Tempus AI, Inc. | Cardiovascular | 510(k) | 2026-09-25 |
| KARL STORZ SUPRALOOP (K254303): 510(k) cleared for Karl Storz SE & CO. KG | Obstetrics/Gynecology | 510(k) | 2026-09-24 |
| PicoreMax (PicoreMax) (K254199): 510(k) cleared for BLUECORE COMPANY Co., Ltd. | General, Plastic Surgery | 510(k) | 2026-09-24 |
| Align® Cover and Pad Guidance Tool (K260114): 510(k) cleared for CIVCO Medical Instruments Co., Inc. | Radiology | 510(k) | 2026-09-24 |
| Portable Oxygen Concentrator (OX-1A-E, OX-1B) (K254289): 510(k) cleared for Oxytek Medical Technology Co., Ltd. | Anesthesiology | 510(k) | 2026-09-23 |
| Everslide (K260117): 510(k) cleared for Special Situations, LLC | Obstetrics/Gynecology | 510(k) | 2026-09-23 |
| Actolind® (06.3637. Actolind® Gel Plus) (K254168): 510(k) cleared for ACTO GmbH | Other | 510(k) | 2026-09-22 |
| Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) (K243223): 510(k) cleared for Bh Group Us, LLC | General, Plastic Surgery | 510(k) | 2026-09-22 |
| Echo-2 (K254240): 510(k) cleared for Neko Health AB | Cardiovascular | 510(k) | 2026-09-22 |
| ErgoSteel (ES0001/696) (K253762): 510(k) cleared for Strongback Mobility AG C/O Blueaudit GmbH | Other | 510(k) | 2026-09-22 |
| F.A.S.T Screw (K254280): 510(k) cleared for Steps Ortho | Orthopedic | 510(k) | 2026-09-21 |
| Hyperdrive 35 Guidewire (K253146): 510(k) cleared for Rapid-Medical , Ltd. | Cardiovascular | 510(k) | 2026-09-18 |
| Ecomed Disposable Administration Sets (K254123): 510(k) cleared for Ecomed Solutions, LLC | General Hospital | 510(k) | 2026-09-11 |
| Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) (K253063): 510(k) cleared for Vitaltec Corporation | Anesthesiology | 510(k) | 2026-09-11 |
| EASYMAX Voice Blood Glucose Monitoring System (K261293): 510(k) cleared for EPS Bio Technology Corp. | Clinical Chemistry | 510(k) | 2026-10-23 |
| Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set (K260857): 510(k) cleared for Sol-Millennium Medical, Inc. | Clinical Chemistry | 510(k) | 2026-10-21 |
| Dynamis Pro Family (K252723): 510(k) cleared for Fotona D.O.O. | General, Plastic Surgery | 510(k) | 2026-09-19 |
| SmartIPL_NI System (K241973): 510(k) cleared for Lumenis Be, Ltd. | General, Plastic Surgery | 510(k) | 2026-09-19 |
| Triever Duo Catheter (K253419): 510(k) cleared for Inari Medical, Inc. | Cardiovascular | 510(k) | 2026-09-18 |
| Deterioration Index Version 2 (K260008): 510(k) cleared for Epic Systems Corporation | Cardiovascular | 510(k) | 2026-09-18 |
| Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (K254171): 510(k) cleared for Shenzhen Mericonn Technology Co., Ltd. | Anesthesiology | 510(k) | 2026-09-18 |
| VacHeal Negative Pressure Wound Therapy System (K254160): 510(k) cleared for VacHeal, LLC | General, Plastic Surgery | 510(k) | 2026-09-18 |
| Drainage Catheter (K254179): 510(k) cleared for Canyon Medical, Inc. | Gastroenterology, Urology | 510(k) | 2026-09-18 |
| 25G Huber Needle (K254095): 510(k) cleared for Martech Medical Products | General Hospital | 510(k) | 2026-09-18 |
| MINT MONO Sutures (K254238): 510(k) cleared for Hans Biomed Corporation | General, Plastic Surgery | 510(k) | 2026-09-18 |
| The VEGA Cervical Screw System (K254260): 510(k) cleared for GS Medical Co., Ltd. | Orthopedic | 510(k) | 2026-09-17 |
| HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) (K254196): 510(k) cleared for Ethicon Endo-Surgery, LLC | General, Plastic Surgery | 510(k) | 2026-09-17 |
| Durashield Device Kit (K252995): 510(k) cleared for SurGenTec, LLC | Neurology | 510(k) | 2026-09-17 |
| Wearable Breast Pump (Model S36) (K254203): 510(k) cleared for Shenzhen TPH Technology Co., Ltd. | Obstetrics/Gynecology | 510(k) | 2026-09-17 |
| Dia-X Sil Light Body (K254152): 510(k) cleared for DiaDent Group International | Dental | 510(k) | 2026-09-16 |
| Dia-X Sil Heavy Body (K254142): 510(k) cleared for DiaDent Group International | Dental | 510(k) | 2026-09-16 |
| Aristotle 65 Macrowire (K254181): 510(k) cleared for Scientia Vascular | Cardiovascular | 510(k) | 2026-09-16 |
| NC PTA Balloon Dilatation Catheter (K254212): 510(k) cleared for Kossel Medtech (Suzhou) Co., Ltd. | Cardiovascular | 510(k) | 2026-09-16 |
| 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 | Other | 510(k) | 2026-09-15 |
| OOOPDS (K254214): 510(k) cleared for Taiwan Main Orthopaedic Biotechnology Co., Ltd. | Radiology | 510(k) | 2026-09-15 |
| colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) (K253481): 510(k) cleared for Ovesco Endoscopy AG | Gastroenterology, Urology | 510(k) | 2026-09-14 |
| BoneVue (K254072): 510(k) cleared for Curvebeam AI / Curvebeam, LLC | Radiology | 510(k) | 2026-09-11 |
| Potenza Prime (K254185): 510(k) cleared for Jeisys Medical Incorporated | General, Plastic Surgery | 510(k) | 2026-09-11 |
| GSPE Spacer (K260063): 510(k) cleared for The General Hospital Corporation, d/b/a Massachusetts | Orthopedic | 510(k) | 2026-09-11 |
| Extroducer Infusion Catheter System (K254051): 510(k) cleared for SmartWise Sweden AB | Cardiovascular | 510(k) | 2026-09-11 |
| Mint ACE Pump (K260001): 510(k) cleared for Beta Bionics, Inc. | Clinical Chemistry | 510(k) | 2026-09-11 |
| Disposable Sterile Skull Drill (LZ) (K254177): 510(k) cleared for Guizhou Zirui Technology Co., Ltd. | Neurology | 510(k) | 2026-09-11 |
| SkinSmart Antimicrobial HydroGel (K254041): 510(k) cleared for Magic Science Supply, LLC | Other | 510(k) | 2026-09-11 |
| 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 | Cardiovascular | 510(k) | 2026-09-11 |
| Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 90 with Luer Lock - Sterile (30032); Polymed TUR Irrigation Set, Y-Type, 4 Leads, Tubing, 90 with Luer Lock- Sterile (30033); Polymed TUR Irrigation Set, Sin | Gastroenterology, Urology | 510(k) | 2026-10-23 |
| VENTANA MMR IHC Panel (K260776): 510(k) cleared for Roche Tissue Diagnostics, Inc. | Other | 510(k) | 2026-10-23 |
| Kinetic Software Library (K260640): 510(k) cleared for Monebo Technologies, Inc. | Cardiovascular | 510(k) | 2026-10-23 |
| BlineSlide (K261679): 510(k) cleared for Deep Breathe, Inc. | Radiology | 510(k) | 2026-10-23 |
| Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter (K260686): 510(k) cleared for Zylox Medtech Co., Ltd. | Cardiovascular | 510(k) | 2026-10-22 |
| MultiNeO Dental Implant System (K261295): 510(k) cleared for Alpha Bio Tec , Ltd. | Dental | 510(k) | 2026-10-22 |
| FAQ (FAQ 411) (K261565): 510(k) cleared for Foreo, Inc. | Neurology | 510(k) | 2026-10-22 |
| 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 | Other | 510(k) | 2026-10-22 |
| PV-iCurve Pro (K261531): 510(k) cleared for Perception Vision Medical Technology Co., Ltd. | Radiology | 510(k) | 2026-10-21 |
| DASH Flu A/B Test (K261347): 510(k) cleared for Nuclein, LLC | Microbiology | 510(k) | 2026-10-21 |
| Versius Surgical System (Versius Plus) (K261252): 510(k) cleared for Cmr Surgical Limited | General, Plastic Surgery | 510(k) | 2026-10-21 |
| Lilium one (USM330) (K260605): 510(k) cleared for Lilium Otsuka Co., Ltd. | Radiology | 510(k) | 2026-10-16 |
| AnyPlus II Spinal Fixation System (K261217): 510(k) cleared for GS Medical Co., Ltd. | Orthopedic | 510(k) | 2026-10-02 |
| CVS Advanced PLUS Blood Glucose Monitoring System (K260689): 510(k) cleared for I-Sens, Inc. | Clinical Chemistry | 510(k) | 2026-10-02 |
| BellaTek Bars (K260940): 510(k) cleared for ZimVie US Corp, LLC | Dental | 510(k) | 2026-09-21 |
| Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection); Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Reverse Deflection) (K260708): 510(k) cleared for Vein 360 | Gastroenterology, Urology | 510(k) | 2026-10-20 |
| Freedom Nail Ankle Fusion System (K261189): 510(k) cleared for McGinley Orthopaedic Innovations | Orthopedic | 510(k) | 2026-10-19 |
| Access MeMed BV (K261109): 510(k) cleared for Beckman Coulter, Inc. | Microbiology | 510(k) | 2026-10-19 |
| multiFiltratePRO System (K261203): 510(k) cleared for Fresenius Medical Care Renal Therapies Group, LLC | Gastroenterology, Urology | 510(k) | 2026-10-19 |
| Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) (K261574): 510(k) cleared for Hong Qiangxing (Shenzhen) Electronics Limited | Neurology | 510(k) | 2026-10-16 |
| 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 | Radiology | 510(k) | 2026-10-16 |
| Sensinel Cardiopulmonary Management (CPM) System (K260801): 510(k) cleared for Analog Devices | Cardiovascular | 510(k) | 2026-10-16 |
| Restrata (K261245): 510(k) cleared for Acera Surgical, Inc. | Other | 510(k) | 2026-10-16 |
| Single-Use EBUS Balloon (K261616): 510(k) cleared for Micro-Tech (Nanjing) Co., Ltd. | Radiology | 510(k) | 2026-10-15 |
| 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 | Other | 510(k) | 2026-10-15 |
| Oncomine Dx Express Test (K260827): 510(k) cleared for Life Technologies Corporation | Other | 510(k) | 2026-10-15 |
| epi-ConneKt Wound Matrix (K260530): 510(k) cleared for MLM Biologics, Inc. | Other | 510(k) | 2026-10-15 |
| KARL STORZ Flexible Video Neuro-Endoscope (K260581): 510(k) cleared for Karl Storz SE & CO. KG | Neurology | 510(k) | 2026-10-14 |
| Radius VSM and Accessories (K260676): 510(k) cleared for Masimo Corporation | Cardiovascular | 510(k) | 2026-10-14 |
| Power Wheelchair (D39) (K261169): 510(k) cleared for Anhui JBH Medical Apparatus Co., Ltd. | Other | 510(k) | 2026-10-14 |
| Yomi S Robotic System (K261321): 510(k) cleared for Neocis, Inc. | Dental | 510(k) | 2026-10-13 |
| Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo) (K261572): 510(k) cleared for Keyue (Hangzhou) Medical Information Technology Co., Ltd. | General, Plastic Surgery | 510(k) | 2026-10-13 |
| 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. | Clinical Chemistry | 510(k) | 2026-10-09 |
| Sleep Analysis Module (K261521): 510(k) cleared for Neurotronics, LLC | Neurology | 510(k) | 2026-10-09 |
| CMF Titanium Splints (K260913): 510(k) cleared for Materialise NV | Dental | 510(k) | 2026-10-09 |
| The D-Tip Denudation Pipette (K261234): 510(k) cleared for Allwin Medical Devices, Inc. | Obstetrics/Gynecology | 510(k) | 2026-10-09 |
| MeCare Alpha (MCA2019) (K260426): 510(k) cleared for IVT Medical, Ltd. | General, Plastic Surgery | 510(k) | 2026-10-08 |
| APEX 3D S Diamond Tibia (K261120): 510(k) cleared for Paragon 28, Inc. | Orthopedic | 510(k) | 2026-10-07 |
| OpenFlo Urinary Catheter (K261141): 510(k) cleared for Urolution Medical, Inc. | Gastroenterology, Urology | 510(k) | 2026-10-06 |
| Power Wheelchair (DC12) (K261079): 510(k) cleared for Anhui JBH Medical Apparatus Co., Ltd. | Other | 510(k) | 2026-10-06 |
| Power Wheelchair (D60) (K261200): 510(k) cleared for Anhui JBH Medical Apparatus Co., Ltd. | Other | 510(k) | 2026-10-06 |
| QGuideCT (1.0) (K260523): 510(k) cleared for Medis Medical Imaging Systems BV | Radiology | 510(k) | 2026-10-05 |
| Lung Guidance (K261042): 510(k) cleared for GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | Radiology | 510(k) | 2026-10-02 |
| H100Plus Hemoglobin Testing System (K260468): 510(k) cleared for Shenzhen Lifotronic Technology Co., Ltd. | Clinical Chemistry | 510(k) | 2026-10-02 |
| 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 | Cardiovascular | 510(k) | 2026-10-02 |
| stentFIX System Set (100.50n) (K260487): 510(k) cleared for Ovesco Endoscopy AG | Gastroenterology, Urology | 510(k) | 2026-10-02 |
| 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. | Cardiovascular | 510(k) | 2026-10-01 |
| Elos Accurate Hybrid Base (K261327): 510(k) cleared for Elos Medtech Pinol A/S | Dental | 510(k) | 2026-09-30 |
| SmartRead(TM) Medical Device Identifier (4100) (DEN260007): 510(k) cleared for BridgeSource Medical Corporation | Cardiovascular | 510(k) | 2026-09-29 |
| CAS-One IR (K261225): 510(k) cleared for Cascination AG | Radiology | 510(k) | 2026-09-29 |
| Liora Monofilament Scaffold (K260474): 510(k) cleared for TELA Bio, Inc. | General, Plastic Surgery | 510(k) | 2026-09-28 |
| VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL) (K260619): 510(k) cleared for Biomérieux, Inc. | Microbiology | 510(k) | 2026-09-28 |
| 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 | Other | 510(k) | 2026-09-27 |
| Profoject LOR Syringe (K261372): 510(k) cleared for CMT Health PTE., Ltd. | Anesthesiology | 510(k) | 2026-09-25 |
| Xpert Respiratory Panel (K261336): 510(k) cleared for Cepheid | Microbiology | 510(k) | 2026-09-25 |
| Altis Full Face Mask (K261262): 510(k) cleared for Respironics, Inc. | Anesthesiology | 510(k) | 2026-09-25 |
| Disposable Belts for Polysomnography (CNSAC) (K260949): 510(k) cleared for CNSAC Medshop GmbH | Anesthesiology | 510(k) | 2026-09-24 |
| Pediatric Nailing Platform Femur (K261345): 510(k) cleared for OrthoPediatrics Corp. | Orthopedic | 510(k) | 2026-09-24 |
| MD-6000S Bladder Scanner (K260313): 510(k) cleared for MEDA Co., Ltd. | Radiology | 510(k) | 2026-09-24 |
| Electric Scooter (FNS01,FNS03) (K261078): 510(k) cleared for Anhui Jbh Medical Apparatus Co., Ltd. | Other | 510(k) | 2026-09-24 |
| VIRTUE QA (K260597): 510(k) cleared for ProNova Solutions | Radiology | 510(k) | 2026-09-23 |
| DynaNail Helix® Fixation System (K260995): 510(k) cleared for MedShape, Inc. | Orthopedic | 510(k) | 2026-09-23 |
| BodyTom 64 (NL4100); OmniTom Elite (NL5000) (K261125): 510(k) cleared for Samsung HME America, Inc., dba NeuroLogica Corp. | Radiology | 510(k) | 2026-09-22 |
| Disposable Ureteral Access Sheath (K260512): 510(k) cleared for Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Gastroenterology, Urology | 510(k) | 2026-09-21 |
| ZYLOX Hippo PTA Balloon Dilatation Catheter (K260416): 510(k) cleared for Zylox Medtech Co., Ltd. | Cardiovascular | 510(k) | 2026-09-21 |
| STAR Apollo Mapping System (K263380): 510(k) cleared for Rhythm AI, Ltd. | Cardiovascular | 510(k) | 2026-10-23 |
| Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Cobraid Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one MINITAPE Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one MINITAPE Suture, Co | Orthopedic | 510(k) | 2026-10-23 |
| Tempo Plating System (K263407): 510(k) cleared for Pace Surgical | Orthopedic | 510(k) | 2026-10-23 |
| Xpert Xpress CoV-2/Flu plus (K263333): 510(k) cleared for Cepheid® | Microbiology | 510(k) | 2026-10-22 |
| Veritas Shoulder System (K263421): 510(k) cleared for restor3d, inc. | Orthopedic | 510(k) | 2026-10-22 |
| Eden PACS (K261788): 510(k) cleared for Higia., Inc. d/b/a Eden | Radiology | 510(k) | 2026-10-21 |
| ACHM30 AtriClip FLEX-Mini LAA Exclusion System (K263319): 510(k) cleared for AtriCure, Inc. | General, Plastic Surgery | 510(k) | 2026-10-21 |
| TeKBrace Knotless Anchor (K263352): 510(k) cleared for TheraMicro | Orthopedic | 510(k) | 2026-10-21 |
| Mint ACE Pump (K263422): 510(k) cleared for Beta Bionics, Inc. | Clinical Chemistry | 510(k) | 2026-10-21 |
| MOWANA Auto Duo (K261266): 510(k) cleared for PENTAMASTER MEDIQ SDN BHD | General Hospital | 510(k) | 2026-09-17 |
| YJ-K1K2 Wheelchair (YJ-013F) (K260145): 510(k) cleared for Zhenjiang Assure Medical Equipment Co., Ltd. | Other | 510(k) | 2026-09-15 |
| Reclining wheelchair (YJ-013L) (K260144): 510(k) cleared for Zhenjiang Assure Medical Equipment Co., Ltd. | Other | 510(k) | 2026-09-15 |
| Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C) (K260141): 510(k) cleared for Zhenjiang Assure Medical Equipment Co., Ltd. | Other | 510(k) | 2026-09-15 |
| CADDIE (K260133): 510(k) cleared for Odin Medical Limited | Gastroenterology, Urology | 510(k) | 2026-09-12 |
| Single Use Ureteral Access Sheath (K260410): 510(k) cleared for Zhejiang Chuangxiang Medical Technology Co., Ltd. | Gastroenterology, Urology | 510(k) | 2026-09-11 |
| OTOPLAN (K262080): 510(k) cleared for Cascination AG | Radiology | 510(k) | 2026-10-23 |
| ANTHEM Fracture System (K262779): 510(k) cleared for Globus Medical, Inc. | Orthopedic | 510(k) | 2026-10-23 |
| DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent (K261792): 510(k) cleared for Medtronic | Other | 510(k) | 2026-10-23 |
| RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747) (K261982): 510(k) cleared for Smith & Nephew Medical, Ltd. | General, Plastic Surgery | 510(k) | 2026-10-23 |
| Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9) (K262752): 510(k) cleared for Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. | General, Plastic Surgery | 510(k) | 2026-10-23 |
| S.I.N. Instruments Kits (K262084): 510(k) cleared for S.I.N. Implant System Ltda | General Hospital | 510(k) | 2026-10-22 |
| PicoPeak Picosecond Nd:Yag Laser System (Bella-9) (K262701): 510(k) cleared for Beijing Sea Heart International Science and Technologyco.Ltd | General, Plastic Surgery | 510(k) | 2026-10-22 |
| Cerclage Wires;K-wires;Steinmann Pins (K262126): 510(k) cleared for MK Medical GmbH | Orthopedic | 510(k) | 2026-10-22 |
| GANNET® (K262184): 510(k) cleared for BAAT Medical Products B.V. | Orthopedic | 510(k) | 2026-10-22 |
| Toro 71 Aspiration Catheter; Toro Aspiration Tubing (K262021): 510(k) cleared for Toro Neurovascular, Inc. | Cardiovascular | 510(k) | 2026-10-21 |
| BIOFIRE SPOTFIRE Vaginitis (VG) Panel (K262136): 510(k) cleared for Biofire Diagnostics, LLC | Microbiology | 510(k) | 2026-10-21 |
| SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control (K262573): 510(k) cleared for Maine Molecular Quality Controls, Inc. | Microbiology | 510(k) | 2026-10-21 |
| Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody System (K262646): 510(k) cleared for Alphatec Spine, Inc. | Orthopedic | 510(k) | 2026-10-21 |
| INNI-CERA (BCM-W500, BCM-W1000) (K262980): 510(k) cleared for DentMedi Co., Ltd. | Dental | 510(k) | 2026-10-21 |
| SCENARIA View Phase 6.0 (K261229): 510(k) cleared for Fujifilm Corporation | Radiology | 510(k) | 2026-09-18 |
| UNIDRIVE Select System (K261102): 510(k) cleared for Karl Storz SE & CO. KG | Obstetrics/Gynecology | 510(k) | 2026-09-18 |
| Dental Diode Laser Device (Laser-Pen) (K261047): 510(k) cleared for Guilin Kevin Peter Technology Co., Ltd. | General, Plastic Surgery | 510(k) | 2026-09-18 |
| M-Vizion Femoral Revision System Extension (K260173): 510(k) cleared for Medacta International S.A. | Orthopedic | 510(k) | 2026-09-17 |
| Vessel Closure Device (VCD177213P) (K260677): 510(k) cleared for Vcd Medical S.R.L. | General, Plastic Surgery | 510(k) | 2026-09-17 |
| Unity Total Knee System, Unity Knee Cementless CR Femur (K261275): 510(k) cleared for Corin, Ltd. | Orthopedic | 510(k) | 2026-09-17 |
| APERTO Lucent MRI System (K261283): 510(k) cleared for Fujifilm Corporation | Radiology | 510(k) | 2026-09-16 |
| ElintMAX Respiratory Monitor (ElintMAX Monitor A1) (K260226): 510(k) cleared for Amptron Medical, Inc. | Anesthesiology | 510(k) | 2026-09-16 |
| 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 | Other | 510(k) | 2026-09-16 |
| a2z-Abdo-Triage (K260906): 510(k) cleared for A2z Radiology Ai, Inc. | Radiology | 510(k) | 2026-09-16 |