| Clivia series Diagnostic Ultrasound System (K211886) | Shenzhen Wisonic Medical Technology Co. , Ltd. | 2021-12-02 |
| OxyLight 2.0 (K202175) | Raja Trading Company, Inc. | 2021-12-02 |
| NGM WAVE PLIF Cage (K212050) | NGMedical GmbH | 2021-12-01 |
| Sphincterotome / short-wire compatible, Sterile Sphincterotome (K210934) | Micro-Tech (Nanjing) Co., Ltd. | 2021-12-01 |
| Electric Breast Pump (K211755) | Zhejiang Carebao Co., Ltd. | 2021-12-01 |
| Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR (K213305) | Canon Medical Systems Corporation | 2021-12-01 |
| AC Cream - Conductive paste (K212326) | Spes Medica Srl | 2021-12-01 |
| dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T (K212864) | Philips Healthcare (Suzhou) Co., Ltd. | 2021-12-01 |
| Milli Vaginal Dilator (K211959) | Materna Medical | 2021-12-01 |
| Powder free nitrile examination glove- blue, non-sterile (K212804) | Hong Seng Gloves Sdn Bhd | 2021-12-01 |
| Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) (K212789) | 5r Med Instruments (Chengdu) Co., Ltd. | 2021-12-01 |
| ARROW Short Stem Humeral System (K202024) | FH Industrie | 2021-11-30 |
| KardiaMobile Card (K211668) | AliveCor, Inc. | 2021-11-30 |
| Paltop Narrow Implant (K210117) | Paltop Advanced Dental Solutions, Ltd. | 2021-11-30 |
| InstruSafe Instrument Protection System (K210836) | Summitt Medical, LLC | 2021-11-30 |
| Disposable Surgical Face Mask (K211696) | Anhui Cleanpro Pharmpack Co., Ltd. | 2021-11-30 |
| Sherlock (K212664) | Open Implants, LLC | 2021-11-30 |
| geko W-2 (K212762) | Firstkind Limited | 2021-11-29 |
| C2 CryoBalloon Ablation System (K212814) | Pentax of America, Inc. | 2021-11-29 |
| ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) (K210930) | Johnson & Johnson Vision Care, Inc. | 2021-11-29 |
| 3D-Cut (K212237) | 3D-Side S.A. | 2021-11-29 |
| RCT700 (K213226) | Ray Co., Ltd. | 2021-11-29 |
| SeptiCyte RAPID (K203748) | Immunexpress, Inc. | 2021-11-29 |
| Nitrile Examination Gloves (K212722) | Wuhan Huirui Technology Co., Ltd. | 2021-11-26 |
| Synthetic Nitrile Examination Gloves (K212488) | Shandong Hongxin Chemicals Co., Ltd. | 2021-11-26 |
| Tablo Cartridge (K210782) | Outset Medical, Inc. | 2021-11-26 |
| MammoScreen 2.0 (K211541) | Therapixel | 2021-11-26 |
| ALTMS Magnetic Stimulation Therapy System (K202537) | Remed Co., Ltd. | 2021-11-26 |
| CUBE Air Purifier (K211139) | Samsung Electronics Co., Ltd. | 2021-11-26 |
| Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula (K210833) | Smiths Medical Asd, Inc. | 2021-11-26 |
| Medical surgical mask (K202842) | Henan Huibo Medical Co., Ltd. | 2021-11-26 |
| Trevo Trak 21 Microcatheter (K211594) | Stryker Neurovascular | 2021-11-26 |
| Atellica CH Enzymatic Creatinine_3 (ECre3) (K212223) | Siemens Healthcare Diagnostics, Inc. | 2021-11-24 |
| MicroPen EVO (K212558) | Eclipse Medcorp, LLC | 2021-11-24 |
| Surgical Mask (sterile) (K211295) | Nanjing 3h Medical Products Co., Ltd. | 2021-11-24 |
| Xpert Wrist (K213214) | Newclip Technics | 2021-11-24 |
| Trachealator (K211894) | Disa Medinotec | 2021-11-24 |
| Regulora (K211463) | Metame Health, Inc. | 2021-11-24 |
| AMRA Profiler (K211983) | Amra Medical AB | 2021-11-24 |
| Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue (K212633) | String King Lacrosse, LLC | 2021-11-24 |
| Non-Contact Infrared Thermometer, model HL710H (K211744) | Health & Life Co., Ltd. | 2021-11-24 |
| The Radian MIS Bunion System (K211650) | Nvision Biomedical Technologies, Inc. | 2021-11-24 |
| Guiding Catheter (K210009) | CenterPoint Systems, LLC | 2021-11-24 |
| C-30 Crown Kit (K211345) | Perfect Fit Crowns, LLC | 2021-11-24 |
| ControlRad Select Model Z (K213455) | Controlrad, Inc. | 2021-11-24 |
| Bronchoscope System (K211169) | Shanghai AnQing Medical Instrument Co., Ltd. | 2021-11-24 |
| Uretero1 Ureteroscope System (K211347) | STERIS Corporation | 2021-11-23 |
| Albumin BCG2 (K203248) | Abbott Ireland Diagnostics Division | 2021-11-23 |
| PCEA Syringe Set (K211649) | Baxter Healthcare Corporation | 2021-11-23 |
| Exablate Prostate System (K212150) | Insightec, Inc. | 2021-11-23 |
| da Vinci SP Firefly Imaging System (K212101) | Intuitive Surgical, Inc. | 2021-11-23 |
| MZ Skin LightMAX Supercharged LED Mask 2.0 (K213184) | Mz Skin | 2021-11-23 |
| Hystero-V Hysteroscope (K202445) | Hysterovue, Inc. | 2021-11-23 |
| Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm (K213454) | Medtronic Powered Surgical Solutions | 2021-11-23 |
| Virtue RF (K211562) | ShenB Co., Ltd. | 2021-11-23 |
| Hypotension Decision Assist Model HDA-OR2 (K212529) | Directed Systems, Ltd. | 2021-11-23 |
| Breathe Easy Mobile Respiratory Monitor (MRM) (K211387) | Sound Life Sciences, Inc. | 2021-11-23 |
| Playboy Premium Silicone Lubricant (K210095) | Thai Nippon Rubber Industry Public Company Limited. | 2021-11-23 |
| Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown (K211765) | Cardinal Health, LLC | 2021-11-23 |
| Myomics Q (K211432) | Phantomics, Inc. | 2021-11-23 |
| Sofia 2 Campylobacter FIA (K211342) | Quidel Corporation | 2021-11-23 |
| 039 Surgical Face Mask (K211956) | Aok Tooling Limited | 2021-11-23 |
| Air compression therapy system FO3002 (K212169) | Foshan Hongfeng Co., Ltd. | 2021-11-23 |
| vPatch (DEN210012) | Virility Medical | 2021-11-23 |
| Pre-Formed Extra Support Guidewire (K211741) | Lake Region Medical | 2021-11-22 |
| Spartan MC 0165 (K213451) | Spartan Micro | 2021-11-22 |
| FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) (K210943) | Abbott Diabetes Care, Inc. | 2021-11-22 |
| VS3 Iridium Sytem (K210265) | Visionsense, Ltd. | 2021-11-22 |
| VITA Akzent LC (K211854) | Vita Zahnfabrik GmbH H Rauter & CO | 2021-11-22 |
| Non-sterile Powder Free Nitrile Examination Gloves (K210990) | Rubberex Alliance Sdn Bhd | 2021-11-22 |
| Eclipse PRO (K211651) | Spacelabs Healthcare, Ltd. | 2021-11-22 |
| Low-frequency Stimulator (Model: AST-645, AST-646) (K212989) | Shenzhen Osto Technology Co., Ltd. | 2021-11-22 |
| Philips Incisive CT on Trailer (K211168) | Philips Healthcare (Suzhou) Co., Ltd. | 2021-11-22 |
| Agile Esophageal OTW Stent System (K211960) | Boston Scientific Corporation | 2021-11-22 |
| Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile) (K203074) | Pt. Universal Gloves | 2021-11-19 |
| BD Nano 2nd Gen Pen Needle (K212015) | Becton, Dickinson and Company | 2021-11-19 |
| Disposable Nitrile Examination Glove (K212661) | Inner Mongolia Cureguard Medical Technology Co., Ltd. | 2021-11-19 |
| EkoSonic Endovascular Device (K211080) | Boston Scientific | 2021-11-19 |
| Vector® Hammertoe Correction System (K213421) | Nvision Biomedical Technologies, Inc. | 2021-11-19 |
| Velofix SA Cervical Cage (K210573) | U&I Corporation | 2021-11-19 |
| Leaf Smooth (K212697) | Shenzhen Leaflife Technology Co., Ltd. | 2021-11-19 |
| HALYARD Flexaprene Green Powder-Free Exam Glove (K211063) | O&M Halyard, Inc. | 2021-11-19 |
| Catalyft LS Expandable Interbody System (K212653) | Medtronic Sofamor Danek USA, Inc. | 2021-11-19 |
| MR 5300 (K212673) | Philips Medical Systems Nederland B.V. | 2021-11-19 |
| Arthrex Vortex Threaded Bone Marrow Recovery Needle (K213213) | Arthrex, Inc. | 2021-11-19 |
| Urinary Catheter 12 Fr, Urinary Catheter 16 Fr (K211032) | Urogen Pharma, Ltd. | 2021-11-19 |
| EndoScreener (K211326) | Chengdu Wision Medical Device Co., Ltd. | 2021-11-19 |
| Frontier Series Power Wheelchairs (K213090) | Magic Mobility | 2021-11-19 |
| OnQ Neuro (K210831) | Cortechs Labs, Inc. | 2021-11-19 |
| Finebeam (K202288) | SNJ Co., Ltd. | 2021-11-19 |
| Capiox iCP Centrifugal Pump (K200091) | Terumo Cardiovascular Systems Corporation | 2021-11-18 |
| Desnuda Reflect (K211998) | Good Clean Love, Inc. | 2021-11-18 |
| Disposable Medical Nitrile Examination Gloves (Non-sterile) (K212600) | Suqian Linglian Medical Technology Co., Ltd. | 2021-11-18 |
| Medley (K212000) | Good Clean Love, Inc. | 2021-11-18 |
| FAICO Dental Implant System and CAD/CAM Abutments (K211871) | Faico Medical, LLC | 2021-11-18 |
| SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System (K211937) | Jiangsu Synecoun Medical Technology Co., Ltd. | 2021-11-18 |
| IPL Hair Removal, Model: OBT-02 (K213041) | Glan Electronics Co., Ltd. | 2021-11-18 |
| Gemini 2 810+980 Soft Tissue Laser (K210350) | Azena Medical, LLC | 2021-11-18 |
| VALORY (K213469) | Agfa N.V. | 2021-11-18 |
| Water-soluble Personal Lubricant (K212104) | Foshan Pingchuang Medical Technology Co., Ltd. | 2021-11-18 |