| PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology (K213125) | Synovis Life Technologies. Inc. (A Subsidiary of Baxter | 2021-10-27 |
| Vydence Zye and Vydence One (K202998) | Vydence Medical Industria E Comercio Ltda | 2021-10-26 |
| EndSnorZ Sleep Appliance (K211069) | Prismatik Dentalcraft, Inc. | 2021-10-26 |
| QuickAligners (K211537) | Oral Image, Inc. | 2021-10-26 |
| Avaira Vitality (K213164) | CooperVision, Inc. | 2021-10-26 |
| Medical Diode Laser Systems (K211977) | Wuhan Dimed Laser Technology Co., Ltd. | 2021-10-26 |
| CLISIS SYSTEMS, Discovery RF180 (K213081) | General Medical Merate S.P.A | 2021-10-26 |
| Disposable Medical Nitrile Examination Gloves (K212363) | Lanhuo Medical Technology (Jiangsu) Co.,Ltd | 2021-10-26 |
| Thrombuster II Aspiration Catheter (K213166) | Kaneka Medical America, LLC | 2021-10-26 |
| Tomier Perform™ Reversed Glenoid Cannulated Glenospheres (K213124) | Tornier, Inc. | 2021-10-26 |
| Best Glove-Nitrile Powder Free Examination Glove (K210249) | Bestsafe Glove Co., Ltd. | 2021-10-25 |
| Introcan Safety 3 Closed IV Catheter (K213085) | B.Braun Medical, Inc. | 2021-10-25 |
| Laser Treatment System, Model: Hera, Armo (K212793) | Canadian Pioneer Medical Technology Corporation | 2021-10-25 |
| Arthrex LoopLoc Knotless Suture (K212146) | Arthrex, Inc. | 2021-10-25 |
| Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A) (K212293) | Jiangmen Ningrui Medical Supplies Co., Ltd. | 2021-10-25 |
| Titan Manufacturing Bipolar Forceps (K213386) | Titan Manufacturing, Inc. | 2021-10-25 |
| Advanced Algorithms for Treatment Management Applications (AATMA) (K212218) | Elekta Solutions AB | 2021-10-25 |
| Ultrasonic Surgical & Electrosurgical Generator (K210488) | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2021-10-25 |
| Disposable Nitrile Examination Glove (K212401) | Inner Mongolia Cureguard Medical Technology Co., Ltd. | 2021-10-25 |
| Surgical Gown (K211509) | Hubei Wanli Protective Products Co., Ltd. | 2021-10-24 |
| Vinyl Examination Gloves(Yellow) (K211698) | Liuping Trading Co., Ltd. | 2021-10-24 |
| Surgical Face Mask (K212368) | Anhui Tiankang Medical Technology Co., Ltd. | 2021-10-24 |
| Disposable Medical Surgical Mask (K210348) | Weihai Dishang Medical Technology Co., Ltd. | 2021-10-24 |
| DiLumen C2 and Tool Mount (K211819) | Lumendi, LLC | 2021-10-22 |
| P300 Attachment (K202120) | Nakanishi, Inc. | 2021-10-22 |
| Cohitech Organic Cotton Non-Applicator Cottonlock Tampons (K211775) | Cotton High Tech S.L. | 2021-10-22 |
| EnSite X EP System (K212061) | Abbott | 2021-10-22 |
| Erchonia XLR8 (K211186) | Erchonia Corporation | 2021-10-22 |
| CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit (K210310) | Nuance Medical, LLC | 2021-10-22 |
| Quantum Anterior Cervical Plate (K210424) | Nvision Biomedical Technologies, Inc. | 2021-10-22 |
| FlightPlan for Liver (K210807) | GE Medical Systems SCS | 2021-10-22 |
| Tyvek(R) Roll with CI for STERLINKTM Sterilizer (K212198) | Plasmapp Co,., Ltd. | 2021-10-22 |
| Aveli (K212399) | Nc8, Inc. | 2021-10-22 |
| UroLift System Rigid Retrieval Kit Sterilization Tray (K212396) | Neotract, Inc. | 2021-10-22 |
| STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette (K212200) | Plasmapp Co,., Ltd. | 2021-10-22 |
| IRNF App (K212516) | Apple, Inc. | 2021-10-22 |
| Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) (K212193) | Plasmapp Co,., Ltd. | 2021-10-22 |
| Neuromark System (K212666) | Neurent Medical | 2021-10-22 |
| CO2 Laser Machine, Model: BW-203B (K211735) | Zhengzhou Bestview ST Co., Ltd. | 2021-10-22 |
| Legend Pro DMA (K200545) | Pollogen, Ltd. | 2021-10-21 |
| IPL Hair Removal Device (K212314) | Zhongshan Bisen Plastic Electronic Products Co., Ltd. | 2021-10-21 |
| Tenax Laser Resistant Endotracheal Tube (K213028) | Bryan Medical, Inc. | 2021-10-21 |
| Orthoscan Tau Mini C-Arm (K213113) | Orthoscan, Inc. | 2021-10-21 |
| Treace Medical Concepts (TMC) Screw Fixation System (K213036) | Treace Medical Concepts, Inc. | 2021-10-21 |
| PENTAX Medical Video Bronchoscope EB11-J10 (K210928) | Pentax of America, Inc. | 2021-10-21 |
| CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories (K211171) | GE Healthcare Finland Oy | 2021-10-21 |
| Portable Scalp Cooling System (K211526) | Cooler Heads Care, Inc. | 2021-10-21 |
| GR Splint Resin System (K211415) | Pro3Dure Medical GmbH | 2021-10-21 |
| Medical Examination Gloves (K212311) | Guangzhou Junda Gloves Co., Ltd. | 2021-10-21 |
| Belun Ring BLR-100X (K211407) | Belun Technology Company Limited | 2021-10-21 |
| DEKA LipoAI (K212270) | El.En Electronic Engineering Spa | 2021-10-21 |
| XO Cross Support Catheter (K210322) | Transit Scientific, LLC | 2021-10-21 |
| Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series (K210618) | Chongqing Jinshan Science & Technology Co., Ltd. | 2021-10-20 |
| InTray GC (K210511) | Biomed Diagnostics Incorporated | 2021-10-20 |
| AVVIGO Guidance System II (K212490) | Boston Scientific Corporation | 2021-10-20 |
| Piccolo Potassium Test System (K200865) | Abaxis, Inc. | 2021-10-20 |
| S.I.N. Dental Implant System (K211921) | S.I.N. - Sistema DE Implante Nacional S.A. | 2021-10-20 |
| EQ-PEX (K210789) | Meta Systems Co., Ltd. | 2021-10-20 |
| iRAD (K212470) | Claritas Healthtech Pte, Ltd. | 2021-10-20 |
| Contour ProtegeAI (K210632) | Mim Software, Inc. | 2021-10-20 |
| MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL (K211672) | Liofilchem s.r.l. | 2021-10-20 |
| PENTAX Medical Video Upper GI Scopes EG17-J10 (K210177) | Pentax of America, Inc. | 2021-10-20 |
| cobas Cdiff nucleic acid test for use on the cobas Liat System (K212427) | Roche Molecular Systems, Inc. | 2021-10-20 |
| Luminopia One (DEN210005) | Luminopia, Inc. | 2021-10-20 |
| Multi-unit Abutment, Multi-unit Angled Abutment (K203808) | Megagen Implant Co., Ltd. | 2021-10-20 |
| PICOHI (K201773) | Hironic Co., Ltd. | 2021-10-19 |
| Sterile High-pressure Angiographic Syringes for Single-use (K211564) | Shenzhen Boon Medical Supply Co., Ltd. | 2021-10-19 |
| Nitrile Examination Gloves (K210706) | Niujian Technology Co., Ltd. | 2021-10-19 |
| Surgical 3D Mask (K203565) | Inno Lifecare | 2021-10-19 |
| Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) (K202982) | Winner Medical Co., Ltd. | 2021-10-19 |
| Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope (K211084) | Shanghai Caremate Medical Device Co., Ltd. | 2021-10-19 |
| MyoWorx TM20 (K192746) | Myoworx, Inc. | 2021-10-19 |
| Single Use Irrigation bipolar cable (K211170) | Modern Medical Equipment Manufacturing, Ltd. | 2021-10-19 |
| WOLF Thrombectomy System, 14F (K210911) | Devoro Medical, Inc. | 2021-10-19 |
| U9000 Plus Ultrafilter (K211035) | Baxter Healthcare Corporation | 2021-10-19 |
| Synergy Gold (SG) Portable (Models MM011450 and MM011460) (K210124) | Uzinmedicare Co. | 2021-10-19 |
| Capsule Vitals Plus Patient Monitoring System (K210204) | Capsule Technologie Sas | 2021-10-19 |
| DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) (K212254) | Hdx Will Corp. | 2021-10-19 |
| AcuPulse CO2 Laser System, Delivery Devices and Accessories (K212703) | Lumenis, Ltd. | 2021-10-19 |
| LOQTEQ Proximal Humerus Plate 3.5 System (K211582) | Aap Implantate AG | 2021-10-18 |
| ClotTriever Thrombectomy System (K212632) | Inari Medical, Inc. | 2021-10-18 |
| Change Healthcare Cardiology (K212528) | Change Healthcare Israel , Ltd. | 2021-10-18 |
| Surgical Gown (K211809) | Wuhan Dymex Healthcare Co., Ltd. | 2021-10-18 |
| BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit (K201017) | Geneohm Sciences Canada, Inc. (Bd Life Sciences) | 2021-10-18 |
| 0909FCB, 1212FCA (K212753) | Rayence Co., Ltd. | 2021-10-18 |
| Allergen-Specific IgE Assay 12 Allergen Bundle (K193613) | Hitachi Chemical Diagnostics, Inc. | 2021-10-18 |
| Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe (K211555) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2021-10-18 |
| Magicore System (K212517) | Innobiosurg Co., Ltd. | 2021-10-15 |
| MultiSure GK Link Blood Glucose and Ketone Monitoring System (K201880) | Apex BioTechnology Corp. | 2021-10-15 |
| AxTiHA Stand-Alone ALIF System (K212967) | Innovasis, Inc. | 2021-10-15 |
| HIVOX OTC Electrical Stimulator, FT610-B (K211403) | Hivox Biotek, Inc. | 2021-10-15 |
| Arm Blood Pressure Monitor (K210563) | Alicn Medical Shenzhen, Inc. | 2021-10-15 |
| CORUS Spinal System-X (K212636) | Providence Medical Technology, Inc. | 2021-10-15 |
| Ortho MI System (K211992) | Osteonic Co., Ltd. | 2021-10-15 |
| RM4 Control Unit (K211224) | Institut Georges Lopez | 2021-10-15 |
| Deka Tiac II (K211091) | El.En Electronic Engineering Spa | 2021-10-15 |
| ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter (K212959) | Siemens Medical Solutions USA, Inc. | 2021-10-15 |
| ViaCath, AcQRate Dx Steerable Catheter (K212593) | Biotronick, Inc. | 2021-10-15 |
| Aqueduct 200 Cervical Dilation Balloon Catheter (K202433) | Gtimd, LLC | 2021-10-15 |
| Sterile Hypodermic Needles for Single Use (K211214) | Azur Medical Company, Inc. | 2021-10-14 |