| HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece (K240200) | Procept Biorobotics | 2024-08-20 |
| MedtFine Safety Lancet (K241848) | Ningbo Caremed Medical Products Co., Ltd. | 2024-08-20 |
| Borvo EVAC System (Ergo); Borvo EVAC System (Classic) (K241458) | Borvo Medical, Inc. | 2024-08-20 |
| Luna 4 plus (K241102) | Foreo, Inc. | 2024-08-20 |
| TDS (TECHWIN DENTAL SYSTEM) (K231932) | Techwin Co., Ltd. | 2024-08-20 |
| CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739) (K234114) | Okapi Medical, LLC Dba Resivant Medical | 2024-08-20 |
| Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044) (K240077) | Covidien | 2024-08-20 |
| CELERITY HP Indicator Tape (PCC077) (K242189) | Steris | 2024-08-20 |
| Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR (K241496) | Canon Medical Systems Corporation | 2024-08-20 |
| OnPoint Augmented Reality Spine System (K241870) | Onpoint Surgical, Inc. | 2024-08-19 |
| Negative Pressure Wound Therapy Device (V-Move, V-Grand) (K241023) | Med Way, Inc. | 2024-08-19 |
| iFuse TORQ TNT™ Implant System (K241504) | SI-BONE, Inc. | 2024-08-19 |
| Histolog® Scanner (Hardware 2.4, Software 3.3) (K241275) | Samantree Medical SA | 2024-08-19 |
| OmniTrans Transport System (K240235) | Shenzhen Dakewe Bio-Engineering Co., Ltd. | 2024-08-19 |
| MT-Bone (K242432) | Mectron S.P.A. | 2024-08-19 |
| HealthCCSng (K241440) | Nano-X AI , Ltd. | 2024-08-19 |
| RibFix Titan™ Fixation System (K241282) | Riverpoint Medical | 2024-08-19 |
| BTL-899MS (K240234) | BTL Industries, Inc. | 2024-08-17 |
| HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)) (K242239) | Gentuity, LLC | 2024-08-16 |
| VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) (K240307) | Shenzhen Vitavitro Biotech Co., Ltd. | 2024-08-16 |
| KLS Martin Oral-Max Implants MR Conditional (bundled) (K241314) | KLS-Martin L.P. | 2024-08-16 |
| HeartKey® Rhythm (K233755) | B-Secur Limited | 2024-08-16 |
| Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aView™ 2 Advance (K242108) | Ambu A/S | 2024-08-16 |
| Avicenna Roboflex (K233700) | Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi | 2024-08-16 |
| Sapphire NC ULTRA Coronary Dilatation Catheter (K233499) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-08-16 |
| ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) (K242127) | Instrumentation Laboratory (IL) Co. | 2024-08-16 |
| SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) (K240978) | MacroLux Medical Technology Co., Ltd. | 2024-08-16 |
| qCT LN Quant (K240740) | Qure.Ai Technologies | 2024-08-16 |
| iTero Lumina™ Pro (K240573) | Align Technology , Ltd. | 2024-08-16 |
| BOSS™ (K223700) | Intelon Optics, Inc. | 2024-08-16 |
| Mecun SpO2 sensor (K231979) | Shenzhen Mecun Medical Supply Co., Ltd. | 2024-08-16 |
| VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System (K222126) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024-08-16 |
| Xenograft Bovine Bone Particulate (K240133) | Collagen Solutions, LLC | 2024-08-16 |
| XTRA Collection sets; XTRA Sequestration set X (K241236) | Sorin Group Italia S.R.L. | 2024-08-16 |
| Human Lubricant (K240081) | Jiangxi Wulinxiang Biological Technology Co., Ltd. | 2024-08-16 |
| JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus (K233896) | Jdentalcare Srl | 2024-08-16 |
| First To Know Syphilis Test (DEN230090) | Nowdiagnostics | 2024-08-16 |
| Reusable Interface Cable 1.5 m (PRD-IFC-002) (K242061) | Creo Medical, Ltd. | 2024-08-15 |
| uMI Panvivo (K241596) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-08-15 |
| NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate (K241754) | Zimmer Switzerland Manufacturing GmbH | 2024-08-15 |
| UltraDrape UGPIV Barrier and Securement (34-15) (K233965) | Parker Laboratories, Inc. | 2024-08-15 |
| Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control (K241401) | Stryker Endoscopy | 2024-08-15 |
| Disposable Pen Injector Assembly (K240961) | Wuxi Nest Biotechnology Co., Ltd. | 2024-08-15 |
| NPseal (20 and 25) (K241522) | Guard Medical, Inc. | 2024-08-15 |
| Medifun Safety Lancet ( MSL1 series) (K241750) | Medifun Corporation | 2024-08-15 |
| MICROLET®NEXT Lancet (K241810) | Ascensia Diabetes Care U.S., Inc. | 2024-08-15 |
| CoLumbo (K241211) | Smart Soft Healthcare | 2024-08-15 |
| Sapphire ULTRA Coronary Dilatation Catheter (K233505) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-08-15 |
| TOV Dental Implant System (K240837) | Rdj Tov Implant, Ltd. | 2024-08-15 |
| PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup (K242077) | Aicheck Biotech, Inc. | 2024-08-14 |
| Catapult Guide Sheath (K240957) | Contract Medical International, GmbH | 2024-08-14 |
| Intimate Rose Vaginal Dilators (K241748) | Plus EV Holdings Dba Intimate Rose | 2024-08-14 |
| COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) (K242057) | Avanos Medical, Inc. | 2024-08-14 |
| CROSSLEAD Tracker (K241510) | Asahi Intecc Co., Ltd. | 2024-08-14 |
| Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel (K241969) | Qingdao Hightop Biotech Co., Ltd. | 2024-08-14 |
| Family of DIMAR DMAX NIV masks (K232836) | Dimar S.P.A. | 2024-08-14 |
| Utepreva Endometrial Sampler (UP01) (K240595) | Utepreva, LLC | 2024-08-14 |
| Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) (K242059) | X-Cel Specialty Contacts, A Walman Optical Company | 2024-08-14 |
| TRAUMAGEL® (K240713) | Cresilon, Inc. | 2024-08-14 |
| BostonSight® Specialty Lenses (K241571) | Boston Foundation For Sight, Inc. D/B/A Bostonsight | 2024-08-14 |
| SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System (K241813) | Si-Technology, LLC | 2024-08-13 |
| ECHELON Synergy MRI System (K241429) | Fujifilm Healthcare Corporation | 2024-08-13 |
| VM-2000 (K240807) | Ventis Medical, Inc. | 2024-08-13 |
| SUPER VELOCE (K241699) | Ilooda Co,., Ltd. | 2024-08-13 |
| Shinetell Digital Pregnancy Test (K241978) | Hangzhou AllTest Biotech Co., Ltd. | 2024-08-13 |
| Diode Laser Therapy Device (DF-DIODE LASER-S1) (K241547) | Weifang Dragonfly Electronics Technology Co., Ltd. | 2024-08-13 |
| Bullsai (K241094) | Turing Medical Technologies, Inc. | 2024-08-13 |
| Power wheelchair (N6101) (K241686) | Zhejiang Zhonglei Medical Technology Co. , Ltd. | 2024-08-13 |
| CoLink NeoFuse MIS Plating System (see attached parts list) (K241387) | In2bones USA | 2024-08-13 |
| Ultravision2™ IonPencil (K240868) | Alesi Surgical Limited | 2024-08-12 |
| aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo® Transforaminal Lumbar Interbody Fusion device (TLIF); aprevo® Anterior Lumbar Interbody Fusion device with Interfixation (ALIF-X) (K241328) | Carlsmed, Inc. | 2024-08-12 |
| Pixie Pulse (SM9068) (K241365) | Pixie Cup, LLC | 2024-08-12 |
| OptimMRI (v2) (K242054) | Rebrain, Sas | 2024-08-12 |
| dS FootAnkle Coil 8ch 1.5T (K242096) | Philips Medical Systems Nederland B.V. | 2024-08-12 |
| SoClean 3+ Bacterial Reduction Device (DEN210037) | Soclean, Inc. | 2024-08-12 |
| Medical Monitor (32HR734S) (K241402) | Lg Electronics.Inc | 2024-08-12 |
| E3D™-C Interbody System (K241846) | Evolution Spine | 2024-08-12 |
| iDart Lyme IgG ImmunoBlot Kit (K233367) | Id-Fish Technology, Inc. | 2024-08-12 |
| Eneka Selectif (K241656) | Termosalud | 2024-08-12 |
| The Trust (K222688) | Genoss Co., Ltd. | 2024-08-09 |
| ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (K240664) | SurGenTec, LLC | 2024-08-09 |
| Access TPO Antibody (K240469) | Beckman Coulter, Inc. | 2024-08-09 |
| SonoMax Series Digital Color Doppler Ultrasound System (K233697) | CHISON Medical Technologies Co., Ltd. | 2024-08-09 |
| MEDIDIODE (K231950) | Medicreations, LLC | 2024-08-09 |
| EnSite™ X EP System (K242016) | ABBOTT MEDICAL | 2024-08-09 |
| CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES (K232404) | Medicon Hellas S.A | 2024-08-09 |
| Electric Wheelchair (Panda 10); Electric Wheelchair (Panda 12) (K240079) | Suzhou Ideal Medical Co., Ltd. | 2024-08-09 |
| HyperSuture All Blue Extension Line (K241376) | Threadstone, LLC | 2024-08-09 |
| F&P Airvo 3 NIV (PT311US) (K233643) | Fisher & Paykel Healthcare, Ltd. | 2024-08-09 |
| F&P Optiflow Flow Diverter (K234053) | Fisher & Paykel Healthcare, Ltd. | 2024-08-09 |
| OdneClean (K233844) | Odne AG | 2024-08-08 |
| Masimo W1 (K240229) | Masimo Corporation | 2024-08-08 |
| 360CAS Knee (K242009) | Kico Knee Innovation Company Pty, Ltd. | 2024-08-08 |
| SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894 (K233312) | Aktormed GmbH | 2024-08-08 |
| SynthVISION 1.0.0 (K240724) | Synthesis Health Intelligence, Inc. | 2024-08-08 |
| Luminopia (K233720) | Luminopia, Inc. | 2024-08-08 |
| GR Resin System MSI (K231775) | Pro3Dure Medical | 2024-08-08 |
| F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) (K234058) | Fisher & Paykel Healthcare, Ltd. | 2024-08-08 |
| i2Contour (K233822) | Mrimath, LLC | 2024-08-08 |
| SMARxT Tubing and Connectors (K233702) | LivaNova USA, Inc. | 2024-08-08 |