| AEROCURE-MD (K203189) | Aerobiotix, Inc. | 2021-01-21 |
| Overlapped Compression Therapy (K202839) | Jkh Health Co., Ltd. | 2021-01-21 |
| Precision Delivery Infusion Set (K202672) | Quest Medical, Inc. | 2021-01-21 |
| pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5 (K200731) | Pjur Group Luxembourg S.A. | 2021-01-21 |
| Dentsply Sirona Universal Spray Glazes (K202629) | Dentsply Sirona | 2021-01-20 |
| CREO Stabilization System, Navigation Instruments, ExcelsiusGPS (K203153) | Globus Medical, Inc. | 2021-01-19 |
| Biocore9 Femoral Head Resurfacing Component (K201219) | Biocore9, LLC | 2021-01-19 |
| Sequel External Fixation Device (K202833) | Sequel Medical, Inc. | 2021-01-19 |
| R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose (K192913) | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 2021-01-19 |
| ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter (K203726) | Siemens Medical Solutions USA, Inc. | 2021-01-19 |
| HBP7 Settable Hemostatic Bone Putty (K202363) | Orthocon, Inc. | 2021-01-19 |
| IntraSight Mobile (K203719) | Volcano Corporation | 2021-01-19 |
| SnugFit All-Suture Anchor (K203485) | Medacta International S.A. | 2021-01-19 |
| Potenza (K201685) | Jeisys Medical, Inc. | 2021-01-19 |
| Ava Fertility Tracker (K200163) | Ava AG | 2021-01-19 |
| Nanum Syringe (K201930) | Nanum Company Co., Ltd. | 2021-01-17 |
| Galapogos (K200565) | Resmed Corp | 2021-01-17 |
| IMMULITE® 2000 Cortisol (K202826) | Siemens Healthcare Diagnostics Products, Ltd. | 2021-01-15 |
| ViewPoint 6 (K203677) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2021-01-15 |
| EBERLE Shaver System C3 and Accessories (K193608) | Eberle GmbH & Co. KG | 2021-01-15 |
| Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525 (K201897) | Richard Wolf Medical Instruments Corporation | 2021-01-15 |
| AccuBrain (K202847) | Brainnow Medical Technology Limited | 2021-01-15 |
| VMCore Biopsy Needle (K201650) | Uro-1, Inc. | 2021-01-15 |
| CD HORIZON™ Spinal System (K203678) | Medtronic Sofamor Danek USA, Inc. | 2021-01-15 |
| NeVa PV Thrombectomy Device (K201085) | Vesalio | 2021-01-15 |
| Gymform Total ABS (K202653) | Well Brain International , Ltd. | 2021-01-15 |
| CarboClear Lumbar Cage System (K203683) | Carbofix Orthpedics , Ltd. | 2021-01-15 |
| Dynanail Mini Hybrid (K203381) | MedShape, Inc. | 2021-01-15 |
| AirPhysio Positive Expiratory Pressure (PEP) Device (K203209) | Airphysio Pty, Ltd. | 2021-01-15 |
| IMMULITE/IMMULITE® 1000 Cortisol (K203270) | Siemens Healthcare Diagnostics Products, Ltd. | 2021-01-15 |
| PERLA® TL posterior osteosynthesis system (K203506) | Spineart | 2021-01-15 |
| Non-contact Electronic Forehead Infrared Thermometer (K201582) | Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. | 2021-01-15 |
| Ali Interbody Fusion System (K203308) | Raed M. Ali, M.D., Inc. | 2021-01-15 |
| Veuron-Brain-pAb (K203142) | Heuron Co., Ltd. | 2021-01-15 |
| Medical Protective Mask (K202107) | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2021-01-15 |
| Vantage Orian 1.5T, MRT-1550, V6.0 (K202767) | Canon Medical Systems Corporation | 2021-01-15 |
| uAI EasyTriage-Rib (K193271) | Shanghai United Imaging Intelligence Co., Ltd. | 2021-01-15 |
| Infrared Thermometer (K201579) | Shenzhen Xunwei Industrial Co., Ltd. | 2021-01-15 |
| Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set (K202141) | Argon Medical Devices, Inc. | 2021-01-15 |
| OmniGuide BeamPath OTO-U Fiber (K203241) | Omniguide, Inc. | 2021-01-14 |
| VELYS™ Robotic-Assisted Solution (K202769) | Depuy Ireland UC | 2021-01-14 |
| Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”) (K202694) | Vycor Medical, Inc. | 2021-01-14 |
| Lockado Repositionable Hemostasis Clip (K202333) | Micro-Tech (Nanjing) Co., Ltd. | 2021-01-14 |
| Trophikos Vaginal Moisturizer (K201922) | Trophikos, LLC | 2021-01-14 |
| EasyPath RF Introducer Sheath (K200702) | Broncus Medical, Inc. | 2021-01-14 |
| Vital Sleep (K201719) | The Snore Reliever Company, LLC | 2021-01-14 |
| ART-Plan (K202700) | Therapanacea | 2021-01-14 |
| Mobius3D (K203669) | Varian Medical Systems, Inc. | 2021-01-14 |
| BioGuard EUS Air/Water and Suction Valves (K202104) | STERIS Corporation | 2021-01-14 |
| Maven Patient-Specific Instrumentation (K202019) | Paragon 28, Inc. | 2021-01-14 |
| M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System (K203671) | Medacta International S.A. | 2021-01-13 |
| ENTity WiFi Video Nasopharyngoscope System (K200609) | Optim, LLC | 2021-01-13 |
| Inion CompressOn Screw (K203105) | Inion OY | 2021-01-13 |
| Procedure face mask (Model: KKF-2A) (K202314) | Han Zhaoqing Sporting Goods Company Limited | 2021-01-13 |
| MyOnyx System (K201014) | Thought Technology , Ltd. | 2021-01-13 |
| StealthStation Cranial Software v1.3.2 (K203639) | Medtronic Navigation, Inc. | 2021-01-13 |
| Polyisoprene Powder Free, Black Colour Surgical Gloves (K192933) | Emerson & Co. Srl | 2021-01-13 |
| BEGO Semados® RS/RSX Implant System (K201700) | Bego Implant Systems GmbH & Co. KG | 2021-01-13 |
| Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i (K201836) | Canon Medical Systems Corporation | 2021-01-12 |
| Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) (K202843) | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | 2021-01-12 |
| NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System (K203129) | Precision Spine, Inc. | 2021-01-12 |
| NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, Modulus ALIF System (K203201) | Nu Vasive, Incorporated | 2021-01-12 |
| Disposable Medical Surgical Mask (K201625) | Tianjin Saiyuan Technology Co., Ltd. | 2021-01-12 |
| Hepatica v1 (Hepatica v1.0.0) (K203280) | Perspectum, Ltd. | 2021-01-12 |
| Micro C Medical Imaging System, M01 (K203658) | Oxos Medical, Inc. | 2021-01-12 |
| C Scope Visualization System (K203526) | Cit Ortho | 2021-01-12 |
| Medical Surgical Mask-Model MP002-5, MP002-6 (K202577) | Jiangmen Sure&Me Medical Product Co., Ltd. | 2021-01-11 |
| Switched Internal Paddles (K203231) | Philips North America, LLC | 2021-01-11 |
| Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm (K203397) | Biopsybell S.R.L. | 2021-01-11 |
| GetSet Surgical GoPLF! Posterior Lateral Fusion System (K202505) | Getset Surgical, SA | 2021-01-11 |
| Striate+™ (K201241) | Orthocell, Ltd. | 2021-01-11 |
| ICE COMPRESSION FIRST, DUO, & MOOVE Systems (K193079) | Mks Paris | 2021-01-11 |
| M-Vizion Femoral Revision System Extension (K201471) | Medacta International S.A. | 2021-01-11 |
| Puritan Bennett Cuff Pressure Manager (K202874) | Covidien, LLC | 2021-01-09 |
| CLEWICU System (ClewICUServer and ClewICUnitor) (K200717) | Clew Medical , Ltd. | 2021-01-09 |
| Button Loop (K202291) | Yunyi (Beijing) Medical Device Co., Ltd. | 2021-01-08 |
| LOGIQ P10, LOGIQ P9, LOGIQ P8 (K203114) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2021-01-08 |
| ACS LD Uni FB Knee System (K203341) | Implantcast GmbH | 2021-01-08 |
| HeartFlow Analysis (K203329) | HeartFlow, Inc. | 2021-01-08 |
| ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System (K201259) | Wrightmedicaltechnologyinc | 2021-01-08 |
| Celerity 20 Steam Biological Indicator for IUSS (K202721) | STERIS Corporation | 2021-01-08 |
| OBS Anchorage Screw, Biokey Anchorage Screw (K202278) | Bomei Co, Ltd. | 2021-01-08 |
| BioGuard Air/Water and Suction Valves (K203630) | Steris Corporations | 2021-01-08 |
| Passion Natural Water Based Lubricant (K202017) | Xr, LLC | 2021-01-08 |
| i-STAT TBI Plasma cartridge with the i-STAT Alinity System (K201778) | Abbott Laboratories | 2021-01-08 |
| SurgiWrap FROST (K200918) | Mast Biosurgery | 2021-01-07 |
| ZSFab Cervical Interbody System (K202488) | Zsfab, Inc. | 2021-01-07 |
| BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1 (K202405) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-01-07 |
| Instylla Delivery Kit (K202544) | Instylla, Inc. | 2021-01-07 |
| TissueTak device (K203117) | Via Surgical , Ltd. | 2021-01-07 |
| BrainInsight (K202414) | Hyperfine Research, Inc. | 2021-01-07 |
| MULTIX Impact (K203345) | Siemens Medical Solutions USA, Inc. | 2021-01-07 |
| MatriDerm (K201577) | Medskin Solutions Dr. Suwelack AG | 2021-01-07 |
| Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate (K202622) | O&M Halyard, Inc. | 2021-01-07 |
| Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B (K200769) | Wilson Instruments (Sha) Co., Ltd. | 2021-01-06 |
| BTL-703-2 (K200382) | Btl | 2021-01-06 |
| InBody (K200560) | Inbody Co., Ltd. | 2021-01-06 |
| OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design (K203465) | OSSIO , Ltd. | 2021-01-06 |
| MULTIX Impact C (K203340) | Siemens Medical Solutions USA, Inc. | 2021-01-06 |
| Thermidas IR System (ThIR-A615) (K200999) | Thermidas Americas, Inc. | 2021-01-06 |