| da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) (K211784) | Intuitive Surgical, Inc. | 2021-08-06 |
| Senographe Pristina (K211725) | GE Healthcare | 2021-08-06 |
| Tiger Reusable Sharps Container (K203305) | International Marketing Specialists, Inc. | 2021-08-06 |
| PAO Cortical Screw (K211435) | Medacta International S.A. | 2021-08-06 |
| ulrichINJECT CT motion (K210541) | Ulrich GmbH & Co. KG | 2021-08-06 |
| TriMed Threaded Intramedullary Nail System (K211783) | TriMed, Inc. | 2021-08-06 |
| Vereos PET/CT (K211764) | Philips Medical Systems Nederland B.V. | 2021-08-06 |
| Nitrile Patient Examination Glove (K210725) | Pingan Medical Products Co., Ltd. | 2021-08-06 |
| 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes (K211202) | Stryker | 2021-08-06 |
| Kosmos (K212100) | EchoNous, Inc. | 2021-08-06 |
| Harmony Latex Dam, Harmony Non-Latex Dam (K203727) | Pamco Distributing, Inc. | 2021-08-05 |
| Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) (K211608) | Jiangsu Cureguard Glove Co., Ltd. | 2021-08-05 |
| Disposable Medical Nitrile Examination Gloves (Non-Sterile) (K211075) | Jiangsu Cherish Medical Technology Co., Ltd. | 2021-08-05 |
| R2 Dermabrasion Tip (for Dermal Cooling System) (K203006) | R2 Technologies, Inc. | 2021-08-05 |
| NeuroSENSE Monitoring System, Model NS-901 (K202621) | Neurowave Systems, Inc. | 2021-08-05 |
| Lateral Spine Truss System (LSTS) Interbody Fusion Device (K211388) | 4Web Medical, Inc. | 2021-08-05 |
| AcQMap High Resolution Imaging and Mapping System (K210680) | Acutus Medical, Inc. | 2021-08-05 |
| EMPHASYS Femoral Stems (K211657) | Depuy Ireland UC | 2021-08-05 |
| Nitrile Patient Examination Gloves (K211434) | Zhangjiagang Huayuan Protective Equipment Co., Ltd. | 2021-08-05 |
| Biomet Microfixation OmniMax MMF System (K202969) | Biomet Microfixation | 2021-08-05 |
| SelectFlex Neurovascular Access System Family (K211893) | Q'Apel Medical, Inc. | 2021-08-05 |
| Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 (K200904) | Tosoh Bioscience, Inc. | 2021-08-05 |
| ARK Lacosamide Assay (K201089) | Ark Diagnostics, Inc. | 2021-08-05 |
| TRACOE vario (K203362) | Tracoe Medical GmbH | 2021-08-05 |
| Tecomet Global Unite Short Stem Instrumentation (K211553) | Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc. | 2021-08-04 |
| Tigon Medical Button System (K211049) | Tigon Medical | 2021-08-04 |
| Alpha Vent PEEK Suture Anchor (K211502) | Stryker Endoscopy | 2021-08-04 |
| PrevisEA Device (K211068) | Entac Medical, Inc. | 2021-08-04 |
| V12 PRO (K210913) | Slk Medical GmbH | 2021-08-04 |
| Disposable Surgical Face Mask (K210643) | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2021-08-04 |
| Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR (K212056) | Canon Medical Systems Corporation | 2021-08-04 |
| DESS Dental Smart Solutions (K203464) | Terrats Medical SL | 2021-08-04 |
| Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream) (K203246) | Atlas Link Technology Co., Ltd. | 2021-08-04 |
| Ultrasonic Bipolar Generator USG-410 with accessories (K211838) | Olympus Medical Systems Corporation | 2021-08-04 |
| Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy) (K211714) | Hengchang (Dongying) Medical Technology Co., Ltd. | 2021-08-04 |
| PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ) (K201246) | Qualimed USA, LLC | 2021-08-03 |
| Minitube Dentasleeve Protective Barrier Sleeves (K211026) | Minitube AB | 2021-08-03 |
| Remex KA6 (K212144) | Remedi Co., Ltd. | 2021-08-03 |
| Surgical Face Mask (K211897) | Zhejiang Hongyu Medicali Commodity Co., Ltd. | 2021-08-03 |
| Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter (K211806) | Venclose, Inc. | 2021-08-03 |
| Cannulated Fasteners and Nuts (K211290) | OsteoCentric Technologies | 2021-08-03 |
| Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) (K211758) | Hartalega NGC Sdn. Bhd. | 2021-08-03 |
| Resection Electrodes with HF cable (K210651) | Olympus Winter & Ibe GmbH | 2021-08-03 |
| ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs (K210724) | Careplus (M) Sdn Bhd | 2021-08-03 |
| OPTI® B-Lac Cassette (K200986) | Opti Medical Systems, Inc. | 2021-08-02 |
| Neodent Implant System - Mini Abutment 60° (K203542) | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2021-08-02 |
| Bullfrog Micro-Infusion Device (K210339) | Mercator Medsystems, Inc. | 2021-08-02 |
| SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs) (K203538) | Medline Industries, Inc. | 2021-08-02 |
| DEXA-C Cervical Interbody System (K210521) | Aurora Spine, Inc. | 2021-08-02 |
| Disposable Medical Mask (K203174) | Dong Guan Kinyet Metal Products Co., Ltd. | 2021-08-02 |
| Relivion (K212106) | Neurolief , Ltd. | 2021-08-02 |
| DynaCAD (K212175) | Invivo Corporation | 2021-08-02 |
| breastscape v1.0 (K211431) | Olea Medical | 2021-08-02 |
| H2H Powder Free Examination Blue Glove (K211182) | Ntl Innovation Co., Ltd. | 2021-08-01 |
| Elexir (K211380) | Nu Eyne Co., Ltd. | 2021-07-30 |
| Disposable Nitrile Examination Gloves (K211264) | Shenzhen Shiqiao Science and Technology Co., Ltd. | 2021-07-30 |
| Mini PCNL-System (K200770) | Trokamed GmbH | 2021-07-30 |
| qER-Quant (K211222) | Qure.Ai Technologies | 2021-07-30 |
| Labat series Diagnostic Ultrasound System (K210154) | Shenzhen Wisonic Medical Technology Co. , Ltd. | 2021-07-30 |
| Summit Patella Plating System (K203408) | Endeavor Orthopaedics, LLC | 2021-07-30 |
| Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform (K203224) | Edwards Lifesciences, LLC | 2021-07-30 |
| Lab Bag with Fabric Pouch (K210248) | Advanced Medical Design Co., Ltd. | 2021-07-30 |
| syngo.via RT Image Suite (K211379) | Siemens Medical Solutions USA, Inc. | 2021-07-30 |
| MEO Med Disposable Medical Face Mask (K210870) | Fujian Meo Medical Technology Limited | 2021-07-30 |
| Wrist Blood Pressure Monitor, Blood Pressure Monitor (K210768) | Andon Health Co, Ltd. | 2021-07-30 |
| BeneHold Surgical Incise Drape with CHG antimicrobial (K202208) | Avery Dennison Belgie Bvba | 2021-07-30 |
| FibroScan 230 (K212035) | Echosens | 2021-07-30 |
| Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System (K211710) | Orthofix, Inc. | 2021-07-30 |
| Fingertip Pulse Oximeter (K210274) | Zhuhai Linte Medical Instrument Co., Ltd. | 2021-07-30 |
| Firefly Needleless Connector (K203796) | Puracath Medical, Inc. | 2021-07-30 |
| UltraLase Flexible CO2 Laser Waveguide (K211761) | W & R Investments, LLC Dba Laser Engineering | 2021-07-30 |
| Disposable Nitrile Medical Examination Glove (K210691) | Jiangsu Cureguard Glove Co., Ltd. | 2021-07-30 |
| Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30 (K203700) | Oxoid Limited (Part of Thermo Fisher Scientific) | 2021-07-30 |
| EMBOTRAP III Revascularization Device (K211338) | Neuravi, Ltd. | 2021-07-30 |
| BD PowerPiCC Catheter (K210264) | Bard Access Systems, Inc. | 2021-07-30 |
| DX-D Imaging Package with XD Detectors (K211790) | Agfa N.V. | 2021-07-30 |
| Pounce Thrombectomy System (K211492) | Surmodics,Inc. | 2021-07-30 |
| PowerDot PD-01MT2 Muscle Stimulator (K210938) | Smartmissimo Technologies Pte, Ltd. | 2021-07-30 |
| Powersculp laser lipolysis system (K211402) | Lotuxs Medtech (Suzhou) Co., Ltd. | 2021-07-30 |
| Sectum (K202780) | Neauvia North America | 2021-07-30 |
| FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) (K201761) | Abbott Diabetes Care, Inc. | 2021-07-30 |
| SMART Taylor Spatial Frame (K210953) | Smith & Nephew, Inc. | 2021-07-29 |
| Disposable Nitrile Medical Examination Glove (K211131) | Siyang Threeguard Medical Supplies Co., Ltd. | 2021-07-29 |
| GMK Sphere Revision (K211664) | Medacta International S.A. | 2021-07-29 |
| FiteBac CC OrthoSeal (K210115) | Largent Health, LLC | 2021-07-29 |
| Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor (K210770) | Andon Health Co, Ltd. | 2021-07-29 |
| CRUXVIEW (K211317) | Cruxell Corp. | 2021-07-29 |
| Vinyl compound examination gloves (K211229) | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2021-07-29 |
| Blue Nitrile Exam Gloves (K211341) | Jiangxi Surefine Medical Co., Ltd. | 2021-07-29 |
| NuVasive Pulse System (K210574) | Nu Vasive, Incorporated | 2021-07-29 |
| Hemafuse System (K210862) | Sisu Global Health | 2021-07-29 |
| BTI Extra-Short Dental Implant System UnicCa (K202825) | B.T.I. Biotechnology Institute, Sl. | 2021-07-29 |
| Zap-X Radiosurgical System (K211663) | Zap Surgical Systems, Inc. | 2021-07-29 |
| Straumann Surgical Cassettes (K203753) | Straumann USA, LLC | 2021-07-29 |
| OCS Lung Solution (K211314) | TransMedics, Inc. | 2021-07-29 |
| Disposable Surgical Face Mask (K210409) | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2021-07-28 |
| Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach (K211874) | William Cook Europe Aps | 2021-07-28 |
| BD Flu+ Syringe (K203359) | Becton, Dickinson and Company | 2021-07-28 |
| Portray (K211014) | Surround Medical Systems | 2021-07-28 |
| Catalyst R1 Reverse Shoulder System (K211991) | Catalyst Orthoscience, Inc. | 2021-07-28 |