| GT5 conductive & abrasive gel (K212787) | Wuhan Greentek Pty , Ltd. | 2021-11-08 |
| FDR Cross (DR-XD 3000) (K212956) | Fujifilm Corporation | 2021-11-08 |
| Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F (K203067) | Qura S.R.L | 2021-11-08 |
| Highspeed Airturbine Handpiece (K202371) | Beijing Dongbo Dental Handpiece Co., Ltd. | 2021-11-08 |
| Medical Examination Gloves (Tested for Use with Chemotherapy) (K212506) | Guangdong Gymda Medical Technology Co.,Ltd | 2021-11-07 |
| Isolation Gown AAMI Level 3 (K212504) | Kenpax International Limited | 2021-11-07 |
| VFSS Pro Mobile Digital Imaging System (K212523) | Imagexray, LLC | 2021-11-05 |
| Disposable Medical Face Mask (K202676) | Zhejiang Senhong Medical&Instrument Co., Ltd. | 2021-11-05 |
| Nitrile Examination Gloves (K212551) | Anhui Fine Glove Medical Technology Co., Ltd. | 2021-11-05 |
| Visible Patient Suite (K212896) | Visible Patient, Sas | 2021-11-05 |
| Microcurrent device (Model: HBR2-1) (K211055) | Shenzhen DJ Medical Equipment Co., Ltd. | 2021-11-05 |
| NextAR™ Spine Platform (K210859) | Medacta International S.A. | 2021-11-05 |
| SoftFix Balloon Trocar (K211577) | Unimax Medical Systems, Inc. | 2021-11-05 |
| Anterion (K211817) | Heidelberg Engineering GmbH | 2021-11-05 |
| Acuson SC2000 Diagnostic Ultrasound System (K211726) | Siemens Medical Solutions USA, Inc. | 2021-11-05 |
| TrueLok Evo (K212044) | Orthofix Srl | 2021-11-05 |
| Resonic Rapid Acoustic Pulse Device (K212502) | Soliton, Inc. | 2021-11-05 |
| Best Glove-Latex Powder Free Examination Glove (K210253) | Bestsafe Glove Co., Ltd. | 2021-11-05 |
| Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) (K212460) | Guangzhou Zhengkang Medical Equipment Co.,Ltd | 2021-11-05 |
| Disposable Nitrile Examination gloves (K212485) | Fujian Yuanxin Safety Protection Technology Co., Ltd. | 2021-11-05 |
| Cervical Stand-Alone System (K212853) | Eminent Spine, LLC | 2021-11-05 |
| CoolSculpting Elite System (K212707) | Zeltiq Aesthetics, Inc. | 2021-11-05 |
| MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System (K212900) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-11-05 |
| Drug Relief v1 (K211971) | Dyansys, Inc. | 2021-11-05 |
| MStim Drop Model: LGT-233 (K202110) | Guangzhou Longest Science & Technology Co., Ltd. | 2021-11-05 |
| Medical Face Mask (K212471) | Haian Medigauze Co., Ltd. | 2021-11-04 |
| IPL Hair Removal Device, model: AI01 (K212897) | Shenzhen Century Dongyuan Technology CO , Ltd. | 2021-11-04 |
| X-FLO Fluid Management System (K210628) | Thermedx, LLC | 2021-11-04 |
| Powder Free Vinyl Examination Gloves (K211103) | Shanghai Shengda Medical Applications Co., Ltd. | 2021-11-04 |
| Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single (K212019) | Jiangsu Micsafe Medical Technology Co., Ltd. | 2021-11-04 |
| Comprehensive® Convertible Glenoid - Vivacit-E Liner (K211729) | Biomet Manufacturing Corp | 2021-11-04 |
| OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System (K212912) | B-One Ortho, Corp. | 2021-11-04 |
| 7 Series Phototherapy Device (K212510) | Daavlin Distributing Co. | 2021-11-04 |
| CARESCAPE R860 (K210384) | Datex-Ohmeda, Inc. | 2021-11-04 |
| 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110) (K212511) | Stryker | 2021-11-04 |
| Disposable Nitrile Examination Glove (K212467) | Inner Mongolia Boming Medical Supplies Co., Ltd. | 2021-11-04 |
| Ortho Aligner System (K212496) | Ortho Lab Services, LLC | 2021-11-04 |
| Dakota ALIF Plate System (K212937) | Precision Spine, Inc. | 2021-11-04 |
| Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B (K211288) | Microlife Intellectual Property GmbH | 2021-11-04 |
| BD Kiestra IdentifA (K191964) | Becton, Dickinson and Company | 2021-11-03 |
| LELTEK Ultrasound Imaging System (Model: LU700 Series) (K210432) | Leltek, Inc. | 2021-11-03 |
| GlideScope BFlex 2.8 Single-Use Bronchoscope (K211947) | Verathon Medical (Canada) Ulc | 2021-11-03 |
| OMNIgene GUT Dx (DEN200040) | DNA Genotek, Inc. | 2021-11-03 |
| Fetal Doppler (K212084) | Shenzhen Mericonn Technology Co., Ltd. | 2021-11-03 |
| S.I.N. Instrument Kits (K212404) | S.I.N. - Sistema DE Implante Nacional S.A. | 2021-11-03 |
| FLUME catheter (K212151) | The Flume Catheter Company, Ltd. | 2021-11-03 |
| REAL INTELLIGENCE CORI (CORI) (K212537) | Blue Belt Technologies, Inc. | 2021-11-03 |
| MOVIX DReamy (K212515) | Stephanix | 2021-11-03 |
| Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization (K211544) | Brainlab AG | 2021-11-03 |
| Nulife (K210969) | Mrk Healthcare Pvt, Ltd. | 2021-11-03 |
| NuVasive Anterior Cervical Plate Systems (K212446) | Nu Vasive, Incorporated | 2021-11-03 |
| SOL-CARE IV Bag Safety Connector (K202732) | Sol-Millennium Medical Group | 2021-11-03 |
| SyMRI (K203372) | Syntheticmr AB | 2021-11-03 |
| ASAP Aspiration Catheter, ASAPLP Aspiration Catheter (K212199) | Merit Medical Systems, Inc. | 2021-11-03 |
| Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor (K201320) | Qura S.R.L | 2021-11-03 |
| IM007 (K210543) | Implicity, Inc. | 2021-11-03 |
| Disposable Medical Mask (K210222) | Guangdong Lide Medical Technology Co., Ltd. | 2021-11-02 |
| Pediatric Nasogastric Feeding Tubes - Single ENFit Port (K210598) | Cair Lgl | 2021-11-02 |
| TaiChiB (K210921) | Our United Corporation | 2021-11-02 |
| Powder Free Nitrile Patient Examination Gloves, Blue Color (K210777) | Shandong Jieshi Medical Products Co., Ltd. | 2021-11-02 |
| Tapestry Biointegrative Implant (K212306) | Embody, Inc. | 2021-11-02 |
| Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) (K210473) | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 2021-11-02 |
| VisionX 3.0 (K213326) | Durr Dental SE | 2021-11-02 |
| Electronic Blood Pressure Monitor (K212171) | Dongguan Kangweile Electronic Technology Co., Ltd. | 2021-11-01 |
| BioFire COVID-19 Test 2 (K211079) | Biofire Defense, LLC | 2021-11-01 |
| SterileRight sterilization pouch and roll (K212338) | Sterileright Packaging Mfg., Inc. | 2021-11-01 |
| DePuy CONDUIT LLIF Angled Inserters (K212823) | Enztec Limited | 2021-11-01 |
| Nitrile Examination Gloves (Blue, Violet) (K211586) | Lyncmed Medical Technology (Beijing) Co., Ltd. | 2021-11-01 |
| Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I) (K212948) | Guangzhou Xinbo Electronic Co., Ltd. | 2021-11-01 |
| Alpha Dent Implants Dental Implants System (K210499) | Alpha Dent Implants GmbH | 2021-11-01 |
| Black Nitrile Powder Free Patient Examination Glove, Non Sterile (K210588) | Onetexx Sdn Bhd | 2021-10-31 |
| Tracheal Stent System (Y-Shaped) (K212403) | Micro-Tech (Nanjing) Co., Ltd. | 2021-10-30 |
| Phoenix Digital Thermometer (K201032) | Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. | 2021-10-29 |
| CARTO 3 EP Navigation System Version 7.2 (K213264) | Biosense Webster, Inc. | 2021-10-29 |
| SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free (K212308) | Srirungruang Global Co., Ltd. | 2021-10-29 |
| VersaWrap (K213163) | Alafair Biosciences, Inc. | 2021-10-29 |
| N Latex FLC kappa, N Latex FLC lambda (K201496) | Siemens Healthcare Diagnostics Products GmbH | 2021-10-29 |
| ATEC Alignment App (K211987) | Alphatec Spine, Inc. | 2021-10-29 |
| Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF (K212389) | Intelivation, LLC | 2021-10-29 |
| TraumaGuard Intra-abdominal Pressure Sensing System (K210570) | Sentinel Medical Technologies, LLC | 2021-10-29 |
| Critical Care Suite with Endotracheal Tube Positing AI algorithm (K211161) | Ge Medical Systems, LLC | 2021-10-29 |
| ds Head 32ch 3.0T (K213351) | Invivo Corporation (Business Trade Name: Philips) | 2021-10-29 |
| nView s1 with nav option (K211064) | Nview Medical | 2021-10-29 |
| Enbio S (K210279) | Enbio Group AG | 2021-10-29 |
| MectaLIF Extension (K212831) | Medacta International S.A. | 2021-10-29 |
| Balloon BS-3 (K213195) | Fujifilm Corporation | 2021-10-29 |
| APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module (K200839) | Clever Culture Systems | 2021-10-28 |
| Disposable Nitrile Examination Gloves (Powder free, Blue) (K211581) | Leping Shengde Medical Technology Company Limited | 2021-10-28 |
| VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL) (K210287) | bioMerieux, Inc. | 2021-10-28 |
| Disposable Monopolar Laparoscopic Tips and Reusable Handles (K211019) | Dannik, LLC | 2021-10-28 |
| TRACKER Plus Kyphoplasty System (K211797) | GS Medical Co., Ltd. | 2021-10-28 |
| EndoTool SubQ 2.1 (K211160) | Monarch Medical Technologies, LLC | 2021-10-28 |
| BonOs Inject Bone Cement; NEO Pedicle Screw System (K212489) | Neo Medical SA | 2021-10-28 |
| AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers (K212424) | STERIS Corporation | 2021-10-28 |
| Examination gloves -Type C (Nitrile gloves) (K212290) | Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. | 2021-10-28 |
| Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs (K211604) | Shanxi Hongjin Plastic Technology Co., Ltd. | 2021-10-27 |
| The Alma Opus System, Colibri Applicator and Tips (K201520) | Alma Lasers, Inc. | 2021-10-27 |
| V.A.C.ULTA Negative Pressure Wound Therapy System (K203316) | Kci, A Part of 3M Health Care Business Group | 2021-10-27 |
| SPIWay Endonasal Access Guide (K213153) | Spiway, LLC | 2021-10-27 |
| Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 (K210873) | Oxoid Limited (Part of Thermo Fisher Scientific) | 2021-10-27 |