| Servator M SALF Solution (K211842) | S.A.L.F. Spa | 2021-12-20 |
| Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console (K213031) | Zoll Circulation, Inc. | 2021-12-20 |
| Mpact® 3D Metal Implants - DMLS Technology (K202568) | Medacta International S.A. | 2021-12-20 |
| Frax 1940 for Nordlys and Frax Pro (K212492) | Candela Corporation | 2021-12-20 |
| TR BAND Radial Compression Device (K213531) | Terumo Medical Corporation | 2021-12-20 |
| ATOZ Mini-Screw (K210559) | Mk Meditech, Inc. | 2021-12-19 |
| Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) (K213048) | Huayuan Medical Technology(Shangqiu) Co., Ltd. | 2021-12-18 |
| Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) (K211457) | Ammex Corporation | 2021-12-18 |
| Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) (K213051) | Yunnan Huazhiyuan Medical Technology Co., Ltd. | 2021-12-18 |
| Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray (K212932) | Nobel Biocare Services AG | 2021-12-18 |
| USA Gloves Nitrile Powder Free Exam Gloves (K211624) | Usa Gloves | 2021-12-18 |
| Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit (K193081) | Rheonix, Inc. | 2021-12-17 |
| Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition (K213715) | Ge Medical Systems, LLC | 2021-12-17 |
| MED RF 4000 (K210077) | F Care Systems USA, LLC | 2021-12-17 |
| Revitive Medic Coach (Model Number 5575AQ) (K210825) | Actegy , Ltd. | 2021-12-17 |
| Donagamex Blue Performance Protective Gown (K203821) | Dong Nai Garment Corporation (Donagamex) | 2021-12-17 |
| EMBOGUARD Balloon Guide Catheter (K212340) | Neuravi Limited | 2021-12-17 |
| NObreath® (K203695) | Bedfont Scientific, Ltd. | 2021-12-17 |
| Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System (K200943) | Circa Scientific, LLC | 2021-12-17 |
| PDO Max Suture with Dual Needle (K210871) | Pdo Max, Inc. | 2021-12-17 |
| InkSpace Imaging Pediatric Body Array (K213397) | Inkspace Imaging, Inc. | 2021-12-17 |
| Libby IAAA v1.0 (K210931) | Dyad Medical, Inc. | 2021-12-17 |
| Cordless Prophy System, Model: i-Polish (K211531) | Guilin Woodpecker Medical Instrument Co., Ltd. | 2021-12-17 |
| Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2 (K203424) | Qura S.R.L | 2021-12-17 |
| Single Use Electrosurgical Knife with Fluid Pump System (K211172) | Micro-Tech (Nanjing) Co., Ltd. | 2021-12-17 |
| Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves (K211209) | Hycare International Co., Ltd. | 2021-12-17 |
| Surgical Face Mask (K212059) | Zhongshan Saifute Labor Protective Articles Co., Ltd. | 2021-12-17 |
| Avenger Radial Head System (K212872) | In2bones USA, LLC | 2021-12-17 |
| Sterile Syringe for Single Use (K210914) | Jiangsu Suyun Medical Material Co., Ltd. | 2021-12-17 |
| Physica system (K213381) | Lima Corporate S.P.A. | 2021-12-17 |
| Topwide Surgical Face Mask (K210102) | Topwide (Hubei) Medical Products Manufacturer | 2021-12-17 |
| RF Vapor System (K213627) | Aqua Medical, Inc. | 2021-12-17 |
| Arthrex Knotless Mini TightRopes (K213644) | Arthrex, Inc. | 2021-12-17 |
| NightOwl (K213463) | Ectosense NV | 2021-12-16 |
| Theia NPWT Foam Wound Dressing Kit (K211277) | Clear Choice Therapeutics, Inc. | 2021-12-16 |
| IPL hair removal machine (K213020) | Shenzhen Borria Technology Co., Ltd. | 2021-12-16 |
| Voyant Fine Fusion Device (EB230) (K202818) | Applied Medical | 2021-12-16 |
| Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo (K212630) | Ellex Medical Pty, Ltd. | 2021-12-16 |
| Surgical Gown, Model: surgical gown-hp-3 (K210355) | Weihai Dishang Medical Technology Co., Ltd. | 2021-12-16 |
| Ponto 5 SuperPower (K213733) | Oticon Medical AB | 2021-12-16 |
| VBrain (K213628) | Vysioneer, Inc. | 2021-12-16 |
| UltiCare Disposable Pen Needles (K213407) | Ultimed Incorporated | 2021-12-16 |
| ArchForm Orthodontic Software System (K213916) | Archform, Inc. | 2021-12-16 |
| Balanced Knee System Uni (K211471) | Ortho Development Corporation | 2021-12-16 |
| Activmotion S DTO (K202803) | Newclip Technics | 2021-12-16 |
| LM Surgical Mask Level 3, LM Surgical Mask Level 2, (K211378) | Liberty Mask, LLC | 2021-12-16 |
| Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio (K212420) | Brainlab AG | 2021-12-16 |
| Connected OR Hub with Device and Voice Control (K212055) | Stryker Corporation | 2021-12-16 |
| Koios DS (K212616) | Koios Medical, Inc. | 2021-12-16 |
| Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy Drugs (K212898) | Rimba Glove Snd Bhd | 2021-12-16 |
| 6MP Color LCD Monitor CL-S600 (K212985) | Jvckenwood Corporation | 2021-12-16 |
| AT (K212645) | At Glove Engineering Sdn. Bhd | 2021-12-16 |
| MIVI Q Distal Access Catheter (K212402) | Mivi Neuroscience, Inc. | 2021-12-16 |
| Profound Matrix (K211217) | Candela Corporation | 2021-12-16 |
| Surgical Face Mask (Non-sterile) (K212398) | Hubei Kimsoul Industrial Co., Ltd. | 2021-12-15 |
| FREEDOM Integrated Syringe Infusion System (K200176) | Repro-Med Systems, Inc. Dba Koru Medical Systems | 2021-12-15 |
| reVive Light Therapy Essentials (K210965) | Led Technologies, Inc. | 2021-12-15 |
| ProTEC-USA EZDoff Gown (K210405) | Cadillac Products, Inc. | 2021-12-15 |
| Transcutaneous Electrical Nerve Stimulator (K210223) | Top-Rank Health Care Co., Ltd. | 2021-12-15 |
| Insignia™ Anterior Cervical Plate System (K213443) | Alphatec Spine, Inc. | 2021-12-15 |
| Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair (K210212) | Psychemedics Corporation | 2021-12-15 |
| Surgical Gown, Reinforced Surgical Gown (K212861) | Wuhan Zonsen Medical Products Co., Ltd. | 2021-12-15 |
| Revolution Peripheral Atherectomy System (K212351) | Rex Medical, L.P. | 2021-12-15 |
| Chocolate PTA Balloon Catheter (K213631) | Medtronic, Inc. | 2021-12-15 |
| Innomed NPWT Silicone Foam Dressing (K202823) | Zhejiang Longterm Medical Technology Co., Ltd. | 2021-12-15 |
| BIT-Motion (K211039) | Dde Mri Solutions, Ltd. | 2021-12-15 |
| Will3D (K211114) | Hdx Will Corp. | 2021-12-15 |
| SIMPACT Sacroiliac Joint Fixation System (K212903) | Life Spine, Inc. | 2021-12-15 |
| Disposable Surgical Mask (K212944) | Heilongjiang Yinjia Medical Equipment Co., Ltd. | 2021-12-15 |
| HealthPPT (K211803) | Zebra Medical Vision, Ltd. | 2021-12-15 |
| Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) (K212919) | Jiujiang Taixin Technology Co., Ltd. | 2021-12-15 |
| RT-Mind-AI (K213155) | Medmind Technology Co., Ltd. | 2021-12-15 |
| Cellusheet, Cellufil (K213092) | Human Biosciences, Inc. | 2021-12-15 |
| Merit Siege Vascular Plug (K212817) | Merit Medical System, Inc. | 2021-12-15 |
| Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL (K211539) | Thermo Fisher Scientific | 2021-12-15 |
| Serranator PTA Serration Balloon Catheter (K213728) | Cagent Vascular, LLC | 2021-12-15 |
| Helianthus (K202822) | Metaltronica Spa | 2021-12-15 |
| Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate (K212781) | Spinal Simplicity, LLC | 2021-12-15 |
| Surgical Face Mask (K212574) | Xiantao Deming Healthcare Products Co., Ltd. | 2021-12-14 |
| Aspira Peritoneal Drainage System (K212675) | Merit Medical Systems, Inc. | 2021-12-14 |
| S2 Pigment Removal System (K202848) | Lightsense Technologies, Ltd. | 2021-12-14 |
| DESS Dental Implants (K212538) | Terrats Medical SL | 2021-12-14 |
| MRIdian Linac System (K212958) | Viewray, Incorporated | 2021-12-14 |
| Instant 20s Indicator (K210481) | True Indicating, LLC | 2021-12-14 |
| PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System (K203716) | Smith and Nephew Medical Limited | 2021-12-14 |
| Blood Collection Needles (K200932) | Vacutest Kima Srl | 2021-12-14 |
| TimeWaver Frequency (K212832) | Timewaver Production GmbH | 2021-12-14 |
| ZEPTO Precision Capsulotomy System (K210827) | Centricity Vision, Inc. | 2021-12-14 |
| Surgical Mask (K210744) | Chongqing PA Xijia Biotechnology Co., Ltd. | 2021-12-14 |
| Nitrile Examination Gloves (Powder free, Blue) (K213029) | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2021-12-14 |
| EkoSonic Endovascular Device, EKOS+ Endovascular Device (K213422) | Boston Scientific Corporation | 2021-12-14 |
| SeaSpine WaveForm C Interbody System (K212904) | SeaSpine Orthopedics Corporation | 2021-12-14 |
| Aesculap Slim Clip Applier (K211572) | Aesculap, Inc. | 2021-12-13 |
| Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black color (K210388) | Mexpo International, Inc. | 2021-12-13 |
| neXus Ultrasonic Surgical Aspirator System (K212060) | Misonix, Inc. | 2021-12-13 |
| SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard (K212706) | Splintek, Inc. | 2021-12-13 |
| Nitrile Examination Gloves (K212924) | Shanxi Nacosa Medical Technology Co.,Ltd | 2021-12-13 |
| MULTIX Impact, MULTIX Impact C (K213700) | Siemens Medical Solutions USA, Inc. | 2021-12-13 |
| Centerpiece Plate Fixation System (K212428) | Medtronic Sofamor Danek | 2021-12-13 |
| Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) (K211942) | Shenzhen Osto Technology Company Limited | 2021-12-13 |