| ASI Plethysmogrpah Analyzer (K200567) | Arterial Stiffness, Inc. | 2021-02-26 |
| SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System (K201967) | CHISON Medical Technologies Co., Ltd. | 2021-02-26 |
| FLARE Single-Use Surgical Laser Fiber (K202702) | Realton (Suzhou) Medical Technology Co., Ltd. | 2021-02-26 |
| Cuptimize (K203651) | Cuptimize, Inc. | 2021-02-26 |
| Erisma LP Navigated Instruments (K202956) | Clariance, Sas | 2021-02-26 |
| imani i1 (K202045) | Imani Co. | 2021-02-26 |
| SubtleMR (K203182) | Subtle Medical, Inc. | 2021-02-26 |
| Bladder Scanner (Model: M3, M3-HD, M4, M4-HD) (K201316) | Suzhou Peaksonic Medical Technology Co., Ltd. | 2021-02-26 |
| Spectral CT (K203020) | Philips Medical Systems Nederland B.V. | 2021-02-26 |
| Brite Tip Radianz Guiding Sheath (K202167) | Cordis Corporation | 2021-02-26 |
| IPL Hair removal (K203510) | Shenzhen Weikai Technology Co.,Ltd | 2021-02-26 |
| Disposable Vinyl Examination Gloves (K203439) | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2021-02-26 |
| Hominis Surgical System (DEN190022) | Momentis Surgical , Ltd. | 2021-02-26 |
| Archworx (K173738) | Utah Medical Products and Services | 2021-02-26 |
| SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System (K201971) | CHISON Medical Technologies Co., Ltd. | 2021-02-25 |
| Tixel System (K202988) | Novoxel , Ltd. | 2021-02-25 |
| Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C (K203332) | Hetaida Technology Co., Ltd. | 2021-02-25 |
| Classic (K203477) | Orthoapnea S.L. | 2021-02-25 |
| Disposable Surgical Mask/Fluid Resistant Procedure Mask (K202240) | Lhm Medical Technology (Hong Kong) Limited | 2021-02-25 |
| Surgical Masks (K203524) | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2021-02-25 |
| KARL STORZ UDEL Sterilization Trays (K201945) | Karl Storz Endoscopy America, Inc. | 2021-02-25 |
| Phenom Catheters (K210230) | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | 2021-02-25 |
| SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System (K201969) | CHISON Medical Technologies Co., Ltd. | 2021-02-25 |
| STOP U Model UXV Device (K203665) | Pollogen, Ltd. | 2021-02-25 |
| Infrared Forehead Thermometer (K202420) | Conmo Electronic Company Limited | 2021-02-25 |
| iFuse-TORQ™ Implant System (K203247) | SI-BONE, Inc. | 2021-02-25 |
| EchoS Family (K202514) | Echolight S.P.A | 2021-02-25 |
| OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System (K203578) | Perimeter Medical Imaging Ai, Inc. | 2021-02-25 |
| Vortek Single Loop Ureteral Stent (K201436) | Coloplast Corp. | 2021-02-25 |
| NinesMeasure (K202990) | Nines, Inc. | 2021-02-25 |
| TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set (K201142) | Simplivia Healthcare , Ltd. | 2021-02-25 |
| 4K UHD Laparoscope (K203255) | Scivita Medical Technology Co., Ltd. | 2021-02-24 |
| CITRESPLINE and CITRELOCK ACL Implants (K210239) | Acuitive Technologies, Inc. | 2021-02-24 |
| Trinity ELE Plus and Trinity ELE Plus Pro (K201906) | Carol Cole Company Dba Nuface | 2021-02-24 |
| Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim (K202003) | Gmp Medicare Sdn. Bhd. | 2021-02-24 |
| Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit (K200734) | Sirius Medical Systems B.V. | 2021-02-24 |
| ExtremiLOCK Lateral Ankle Fusion Plates (K203479) | Osteomed | 2021-02-24 |
| Practical Navigation Surgical Guidance System (PNSGS) (K202184) | Practical Navigation, LLC | 2021-02-24 |
| Triever Catheters (K210195) | Inari Medical | 2021-02-24 |
| BioWaveGO RX (K210202) | Biowave Corporation | 2021-02-24 |
| PROXEO Twist Cordless Polishing System PL-40 H (K201703) | W&H Dentalwerk Buermoos GmbH | 2021-02-24 |
| Lumenis Stellar M22 (DEN200028) | Lumenis, Ltd. | 2021-02-23 |
| Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App (K202048) | Cochlear Americas | 2021-02-23 |
| Nissha Medical Technologies Neutral Electrodes (K203494) | Nissha Medical Technologies, Ltd. | 2021-02-23 |
| Molekule Air Mini, Molekule Air Mini + (K202339) | Molekule, Inc. | 2021-02-23 |
| Velano ExT Extension Set (K200439) | Velano Vascular | 2021-02-23 |
| Veolity (K201501) | MeVis Medical Solutions AG | 2021-02-23 |
| ClotTriever Thrombectomy System (K210190) | Irani Medical, Inc. | 2021-02-23 |
| ClarifEye R1.0, ClarifEye Needle (K201743) | Philips Medical Systems Nederlands B.V. | 2021-02-23 |
| PreXion3D Explorer PRO (K203784) | Prexion Corporation | 2021-02-23 |
| Global Med Systems Milesman Compact Laser (K203804) | Global Med Systems SL | 2021-02-23 |
| Lumify Diagnostic Ultrasound System (K203406) | Philips Ultrasound, Inc. | 2021-02-23 |
| Monaco Rtp System (K202789) | Elekta Solutions AB | 2021-02-23 |
| StitchKit COMBO (K202950) | Origami Surgical | 2021-02-23 |
| GenesisZr 4Y+ (ST1100) Zirconia (K201915) | United Dental Resources Corporation | 2021-02-23 |
| PowerDot PD-01MT2 Muscle Stimulator (K210269) | Smartmissimo Technologies Pte, Ltd. | 2021-02-23 |
| Parcus Titanium Interference Screws (K202662) | Parcus Medical, LLC | 2021-02-22 |
| Foot and Ankle System (K200062) | Leith Medical, LLC | 2021-02-22 |
| Phyziofit Medical Surgical Mask (K201868) | Wellpower Sporting Goods Co., Ltd. | 2021-02-22 |
| Surn5 Electrosurgical Argon Beam Generator and Accessories (K203522) | Surnic Corporation | 2021-02-22 |
| Air Compression Therapy Device, model HW6007 (K210240) | Konliking Tech & Dev. Limited | 2021-02-22 |
| MectaLock Extension (K203493) | Medacta International S.A. | 2021-02-22 |
| COBRA-OS Kit (K201652) | Front Line Medical Technologies, Inc. | 2021-02-22 |
| Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece (K202112) | Storz Medical AG | 2021-02-21 |
| Disposable Intraoperative Probe (DIOP8) (K201425) | Huntleigh Healthcare Limited | 2021-02-19 |
| MyPAO Planning Report (K200589) | Medacta International S.A. | 2021-02-19 |
| NuFACE Mini Plus (K201680) | Carole Cole Company | 2021-02-19 |
| Safety Blood Collection Sets for Single Use (K202188) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2021-02-19 |
| ClearCap Distal Attachment (K202616) | Finemedix Co., Ltd. | 2021-02-19 |
| SPiN Vision Video Bronchoscope System (K202346) | Veran Medical Technologies, Inc. | 2021-02-19 |
| A.L.P.S. Clavicle Plating System (K210192) | Biomet, Inc. | 2021-02-19 |
| Eustachi Ear Pressure Relief Device (K203754) | Exercore, LLC | 2021-02-19 |
| DELTA XTEND Reverse Shoulder System (K210167) | DePuy Orthopaedics, Inc. | 2021-02-19 |
| Ultrasonic Osteotomy Surgical System (K201274) | Smtp Technology Co., Ltd. | 2021-02-19 |
| TruPlan (K202212) | Circle Cardiovascular Imaging, Inc. | 2021-02-19 |
| X-ray Flat Panel Detectors/CareView 3600RF (K202995) | Careray Digital Medical System Co., Ltd. | 2021-02-19 |
| emField (K203488) | Zimmer Medizinsysteme GmbH | 2021-02-19 |
| MiniLoad Syringe (K202432) | Ocuject, LLC | 2021-02-19 |
| Inbrace Orthodontic System (K203442) | Swift Health Systems, Inc. | 2021-02-19 |
| pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med Moisturising glide,pjur med NATURAL glide, We-Vibe Lube made by pjur (K200527) | Pjur Group Luxembourg S.A. | 2021-02-19 |
| Comprehensive Vault Reconstruction System (K202232) | Biomet Manufacturing Corp | 2021-02-19 |
| iMask Disposable Surgical Face Mask (K201182) | Pac-Dent, Inc. | 2021-02-19 |
| Artemis Proximal Femoral Nail System (K201379) | Glw, Inc. | 2021-02-19 |
| CORE E3 Suction/irrigator (K202303) | Conmed Corporation | 2021-02-19 |
| Duo Expandable Interbody Fusion System (K210155) | Spineology, Inc. | 2021-02-19 |
| Advanced Dental Appliance (K203462) | Dasoft Partners | 2021-02-19 |
| Born PT-LIF Cage HA (K202380) | Spineworxx AG | 2021-02-19 |
| Elos Accurate Hybrid Base (K201860) | Elos Medtech Pinol A/S | 2021-02-19 |
| BEGO SEMADOS Tr 58350; BEGO SEMADOS RS/RSX-Line Tray Plus, BEGO Semados Tr 58349; BEGO Semados Tr 58348, BEGO Semados DSTr 58356; Drill Stop Tray Plus (RS/RSX-Line), BEGO SEMADOS PKTr 58357; Prosthetic Kit (K201412) | Bego Implant Systems GmbH & Co. KG | 2021-02-18 |
| LiPPS Analyzer, LiPPS Wire Pressure Guide Wire (K201720) | Beijing Bywave Sensing Medical Technology Co., Ltd. | 2021-02-18 |
| Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60 (K202687) | Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. | 2021-02-18 |
| Green X 18(Model : PHT-75CHS) (K210329) | VATECH Co., Ltd. | 2021-02-18 |
| Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape (K201863) | Somatex Medical Technologies GmbH | 2021-02-18 |
| 3D Accuitomo 150N (K201378) | J. Morita USA, Inc. | 2021-02-18 |
| Demetra Analytics Toolkit (K201408) | Barco N.V. | 2021-02-18 |
| Surgical Face Mask (non-sterile) (K203426) | Nantong Taiweishi Medical Technology Co., Ltd. | 2021-02-18 |
| EsoCheck Cell Collection Device (K210137) | Lucid Diagnostics, Inc. | 2021-02-18 |
| LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus (K202573) | DiaSorin, Inc. | 2021-02-18 |
| PhantomMSK Hip (K210136) | OrthoGrid Systems, Inc. | 2021-02-18 |
| 4CIS SARA Spine System, 4CIS VERTU Spine System (K202498) | Solco Biomedical Company India Private Limited | 2021-02-18 |