| NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System (K210214) | Nu Vasive, Incorporated | 2021-05-24 |
| UltraLight LED System (K210535) | Rohrer Aesthetics, LLC | 2021-05-24 |
| LEGION CR Porous Plus HA Femoral Components (K211246) | Smith & Nephew, Inc. | 2021-05-24 |
| Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (K210975) | Bausch & Lomb, Incorporated | 2021-05-24 |
| Neuro-IOM system with Neuro-IOM.NET software (K190703) | Neurosoft , Ltd. | 2021-05-22 |
| Neurescue device (K210358) | Neurescue Aps | 2021-05-21 |
| Zio ECG Utilization Software (ZEUS) System (K202527) | iRhythm Technologies, Inc. | 2021-05-21 |
| IPL Hair Removal Device (Model: KCA423) (K210119) | Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd. | 2021-05-21 |
| Rover (K211423) | Micro-X Limited | 2021-05-21 |
| Manual Wheelchair, Model A011 (K201461) | Ningbo Shenyu Medical Equipment Co.,Ltd | 2021-05-21 |
| Universal Viewer (K211312) | GE Healthcare | 2021-05-21 |
| Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray (K211273) | Ethicon Endo-Surgery, LLC | 2021-05-21 |
| Zio Monitor (K202359) | iRhythm Technologies, Inc. | 2021-05-21 |
| JWX-1 Plus (Navigo 16/Navigo 24) (K203806) | Yamaha Motor Co., Ltd. | 2021-05-21 |
| Ultrasonic Surgical Aspirator System (K202299) | Smtp Technology Co., Ltd. | 2021-05-21 |
| Impla-NX (Model: ISE-270M) (K201192) | Micro-Nx Co., Ltd. | 2021-05-21 |
| Ignite Anatomic Shoulder System (K202716) | Ignite Orthopedics, LLC | 2021-05-20 |
| Quick-20m (K203331) | Cgx, LLC | 2021-05-20 |
| Penumbra System (Reperfusion Catheter RED 62) (K203440) | Penumbra, Inc. | 2021-05-20 |
| Procedure Mask, Surgical Mask (K202899) | Kenpax International Limited | 2021-05-20 |
| C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner (K211001) | Medtec, Inc. Dba Civco Medical Solutions and Civco | 2021-05-20 |
| Actis DuoFix Hip Prosthesis- Collarless (K210581) | Depuy Ireland UC | 2021-05-20 |
| EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle (K210476) | Cook Ireland, Ltd. | 2021-05-20 |
| VR101 Lubricating Intravaginal Ring (K203377) | J3 Bioscience, Inc. | 2021-05-20 |
| Surgical Isolation Gown (K203415) | Yanbian Pacific Textile Co., Ltd. | 2021-05-20 |
| Vitals360 Multi-Vitals Mobile Monitor (K210086) | Vocare, Inc. | 2021-05-20 |
| YUWELL infrared ear thermometer: YHT101, YHT200 (K203583) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2021-05-20 |
| Xoran Workstation, Model 10050 (K210257) | Xoran Technologies, LLC | 2021-05-20 |
| ATS 5000 Automatic Tourniquet Instrument (K202919) | Mcewen and Associates Consulting , Ltd. | 2021-05-20 |
| Contour Light CL-100 (K202955) | Contour Research, LLC | 2021-05-19 |
| CUVIS-spine (K201569) | Curexo, Inc. | 2021-05-19 |
| CINA CHEST (K210237) | Avicenna.Ai | 2021-05-19 |
| Ohlendorf Clear Aligner (K210540) | Ohlendorf Appliance Laboratory | 2021-05-19 |
| Steam-Dot Process Indicator (K210553) | Propper Manufacturing Co., Inc. | 2021-05-19 |
| GII Spinal Fixation System (K210306) | Coligne AG | 2021-05-19 |
| Overjet Dental Assist (K210187) | Overjet, Inc. | 2021-05-19 |
| Turbett Instrument Pod (K202593) | Turbett Surgical, Inc. | 2021-05-19 |
| TENS & EMS Device (K202866) | Shenzhen Jian Feng Electronic Technology Co., Ltd. | 2021-05-19 |
| Electrosurgical accessory (K210394) | Dornier Medtech America, Inc. | 2021-05-19 |
| Vereos PET/CT (K210880) | Philips Medical Systems Nederland B.V. | 2021-05-19 |
| TECHFIT Patient-Specific Maxillofacial System (K203282) | Industrias Medicas Sampedro S.A.S | 2021-05-19 |
| Disposable Latex Powder Free Examination Gloves (Non-sterile) (K201576) | Pt. Universal Gloves | 2021-05-19 |
| BonOs Inject, Pedicle screw kits, Cement pusher (K202458) | Osartis GmbH | 2021-05-18 |
| True Tulip, True M.I.S. (K210816) | Innovative Surgical Designs, Inc. | 2021-05-18 |
| Persona Revision Knee System Femoral Metaphyseal Cones (K210829) | Zimmer, Inc. | 2021-05-18 |
| MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL) (K202423) | Beckman Coulter, Inc. | 2021-05-18 |
| Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges (K202709) | Ningbo Verykind Medical Device Co., Ltd. | 2021-05-18 |
| Personal Lubricant Jelly (K202667) | Nantong Health & Beyond Hygienic Products, Inc. | 2021-05-18 |
| Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action (K203682) | Olympus Winter & Ibe GmbH | 2021-05-17 |
| Needleless Connector (K210217) | Jiangsu Caina Medical Co.,Ltd | 2021-05-17 |
| Ear-Friendly Mask (K211105) | Ray Co., Ltd. | 2021-05-17 |
| NitriTec Vinyl Glove Powder Free Blue (K210460) | Zhonghong Pulin Medical Products Co., Ltd. | 2021-05-17 |
| Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR (K211037) | Canon Medical Systems Corporation | 2021-05-17 |
| Cercare Medical Neurosuite (K202793) | Cercare Medical Aps | 2021-05-17 |
| Klarity Bolus (K202747) | Klarity Medical & Equipment (GZ) Co., Ltd. | 2021-05-14 |
| Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K210774) | Shandong Jieshi Medical Products Co., Ltd. | 2021-05-14 |
| TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM (K203226) | Richard Wolf Medical Instruments Corporation | 2021-05-14 |
| Cardiac Trigger Monitor (K202138) | Ivy Biomedical Systems, Inc. | 2021-05-14 |
| Disposable Medical mask (K210302) | Anhui Jbh Medical Apparatus Co., Ltd. | 2021-05-14 |
| NPseal (K211130) | Guard Medical, Inc. | 2021-05-14 |
| Powder Free Vinyl Patient Examination Gloves (K210799) | Yunnan Huazhiyuan Medical Technology Co., Ltd. | 2021-05-14 |
| MicroFrance Monopolar and Bipolar Electrosurgical Instruments (K210942) | Integra Microfrance | 2021-05-14 |
| Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL (K210417) | Bio Compression Systems, Inc. | 2021-05-14 |
| 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock (K210200) | Set Medikal Sanayi VE Ticaret Anonim Sirketi | 2021-05-14 |
| BoneTrust Mini Implant System (K200573) | Medical Instinct Deutschland GmbH | 2021-05-14 |
| AcQGuide MAX Steerable Sheath (K211100) | Acutus Medical, Inc. | 2021-05-14 |
| Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K210780) | Shandong Shangwei Medical Products Co., Ltd. | 2021-05-14 |
| HOLOSCOPE-i (K210072) | Real View Imaging , Ltd. | 2021-05-14 |
| Gx-IVF, Gx-TL, Gx-MOPS PLUS (K202862) | Vitrolife Sweden AB | 2021-05-14 |
| Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) (K200555) | Prevest Denpro Limited | 2021-05-13 |
| PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family) (K210485) | Pentax of America, Inc. | 2021-05-13 |
| Powder Free Nitrile Examination Glove (K210369) | Pastel Glove Sdn Bhd | 2021-05-13 |
| Reliance Spinal Screw System (K210874) | Reliance Medical Systems, LLC | 2021-05-13 |
| United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask (K202697) | United Sewing Automation, Inc. | 2021-05-13 |
| Tablet Application (K203566) | Smith & Nephew | 2021-05-13 |
| CryoVIVE (K203481) | Recensmedical, Inc. | 2021-05-13 |
| SIGNA 7.0T (K211118) | Ge Medical Systems, LLC | 2021-05-13 |
| Disposable Face Mask (K210815) | Biobase Scientific (Shandong) Co., Ltd. | 2021-05-13 |
| LinkSymphoKnee System (K202924) | Waldemar Link GmbH & Co. KG | 2021-05-13 |
| A1AT Genotyping Test (K211115) | Progenika Biopharma S.A., A Grifols Company | 2021-05-13 |
| Prelivia (K210979) | Rehabtronics, Inc. | 2021-05-13 |
| GMK Spherika Femurs and Fixed Tibial Trays Plus (K211004) | Medacta International S.A. | 2021-05-13 |
| HS40 Diagnostic Ultrasound System (K210426) | Samsung Medison Co., Ltd. | 2021-05-13 |
| SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate (K210737) | STERIS Corporation | 2021-05-12 |
| NextAR RSA Platform (K210153) | Medacta International S.A. | 2021-05-12 |
| ClotTriever Thrombectomy System (K210689) | Inari Medical, Inc. | 2021-05-12 |
| Automatic Arm Electronic Blood Pressure Monitor (K210435) | Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. | 2021-05-12 |
| High Performance Antimicrobial Gelling Fiber with Silver (K210974) | Advanced Medical Solutions, Ltd. | 2021-05-12 |
| Symbia VA10A Family (K210557) | Siemens Medical Solutions USA, Inc. | 2021-05-12 |
| NuVasive MOD-EX XLIF Interbody System (K210439) | Nu Vasive, Incorporated | 2021-05-12 |
| iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS) (K210809) | Conformis, Inc. | 2021-05-12 |
| Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A) (K202860) | Valley Contax, Inc. | 2021-05-11 |
| DART-FIRE EDGE Cannulated Screw System (K203228) | Wright Medical | 2021-05-11 |
| Neurodyn V2.0, Neurodyn Aussie V2.0 (K210572) | Ibramed Equipamentos Medicos | 2021-05-11 |
| Air Pressure Therapy System: VU-IPC06 (K210967) | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2021-05-11 |
| HANAROSTENT Benefit Biliary (NNN) (K202973) | M.I.Tech Co., Ltd. | 2021-05-11 |
| HD Mediastinoscope (K202272) | Karl Storz Endoscopy America, Inc. | 2021-05-11 |
| ChoiceSpine Blackhawk Ti Cervical Spacer System (K203311) | Choice Spine, LLC | 2021-05-10 |
| Single-use medical poly (vinyl chloride) examination glove (K201504) | Anhui Bytech Medical Supplies Co., Ltd. | 2021-05-10 |
| Yumizen C1200 Creatinine PAP (K193649) | HORIBA ABX SAS | 2021-05-10 |