| CoLink NeoFuse Plating System (K213069) | In2bones USA, LLC | 2021-12-13 |
| Heat StimPlus (K212918) | Famidoc Technology Co., Ltd. | 2021-12-13 |
| Philips Radiology Smart Assistant (K212186) | Philips Medical Systems Dmc GmbH | 2021-12-13 |
| Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer (K212221) | Diazyme Laboratories, Inc. | 2021-12-13 |
| Disposable Surgical Gown, Disposable Reinforced Surgical Gown (K212869) | Fugou County Shenxiang Manufacturing Co., Ltd. | 2021-12-13 |
| Disposable Nitrile Powder-Free Examination Gloves (K213176) | Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. | 2021-12-13 |
| Surgical face mask: F-Y1-A (K202794) | Jiande Chaomei Daily Chemicals Co., Ltd. | 2021-12-13 |
| Disposable Surgical Gown (K212925) | Henan Robestain Medical Products Co., Ltd. | 2021-12-13 |
| Nyquist.IQ (K212890) | Omega Medical Imaging, LLC | 2021-12-13 |
| Iconic Nitrile Glove (K212182) | Iconic Medicare Sdn Bhd | 2021-12-11 |
| Nitrile Gloves (Model: NE01) (K212840) | Byd Auto Industry Company Limited | 2021-12-11 |
| Disposable Vinyl/Nitrile Blend Medical Examination Gloves (K212899) | Bytech(Dongtai) Co., Ltd. | 2021-12-11 |
| Siam NTD+ Nitrile Powder-Free Examination gloves (K212085) | Siam Ntd Corporation Co., Ltd. | 2021-12-11 |
| Medical Surgical Mask (K212867) | Nanchang Kanghua Health Materials Co., Ltd. | 2021-12-11 |
| Dental Scaler and Air Polisher (K203615) | Guilin Woodpecker Medical Instrument Co., Ltd. | 2021-12-10 |
| VerSys Cemented Revision/Calcar (K210842) | Zimmer, Inc. | 2021-12-10 |
| i8 Tanning Booth (K210004) | Ultrasun International B.V. | 2021-12-10 |
| 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads (K211997) | Intuitive Surgical, Inc. | 2021-12-10 |
| Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28 (K201600) | Kangfu Medical Equipment Factory | 2021-12-10 |
| CINtec Histology (K212176) | Ventana Medical Systems, Inc. | 2021-12-10 |
| Branchor Balloon Guide Catheter (K203723) | Asahi Intecc Co., Ltd. | 2021-12-10 |
| AMG PMP Infant (K202510) | Eurosets S.R.L | 2021-12-10 |
| DESS Dental Smart Solutions (K212577) | Terrats Medical SL | 2021-12-10 |
| Comprehensive Humeral Fracture Positioning Sleeves (K212435) | Biomet, Inc. | 2021-12-10 |
| Vy Spine™ VySpan™ PCT System (K213394) | Vy Spine, LLC | 2021-12-10 |
| Airvo Nebulizer Adapter (K211560) | Fisher & Paykel Healthcare Limited | 2021-12-10 |
| UltraClear Fractional Laser System (K210847) | Fa International, LP | 2021-12-10 |
| Invictus Spinal Fixation System (K213460) | Alphatec Spine, Inc. | 2021-12-10 |
| ComfortPro Blue Nitrile Examination Gloves Powder Free (K212850) | Thai Rubber Industry Company Limited | 2021-12-10 |
| Medline UNITE REFLEX Dynamic Discs (K211612) | Medline Industries, Inc. | 2021-12-10 |
| EXA (K203743) | Konica Minolta Healthcare Americas, Inc. | 2021-12-10 |
| Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves (K212349) | Medi Legion Sdn.Bhd | 2021-12-10 |
| X-Clever (K212137) | Lg Electronics.Inc | 2021-12-10 |
| Nitrile Examination Gloves (K212922) | Hsk Medical Apparatus Foshan China Co., Ltd. | 2021-12-10 |
| Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003) (K213638) | Argon Medical Devices | 2021-12-10 |
| JAZZ Solo sensor (K213637) | Jazz Imaging, LLC Dba Jazz Imaging | 2021-12-10 |
| Comfort Marker 2.0. (DEN200041) | Medical Precision BV | 2021-12-10 |
| Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE) (K203539) | Unicoglobal, Inc. | 2021-12-10 |
| NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health (K213543) | Neuronetics, Inc. | 2021-12-10 |
| Plasma IQ (K212329) | Neauvia North America, Inc. | 2021-12-09 |
| LOSPA TKR System (K212034) | Corentec Co., Ltd. | 2021-12-09 |
| Infinity Acute Care System (IACS) Monitoring Solution (K201764) | Draeger Medical Systems, Inc. | 2021-12-09 |
| Nextra CH Cannulated Hammertoe System (K213530) | Nextremity Solutions, Inc. | 2021-12-09 |
| VOCO Retraction Paste (K213149) | Voco GmbH | 2021-12-09 |
| LVivo Seamless (K212466) | Dia Imaging Analysis, Ltd. | 2021-12-09 |
| SeaSpine WaveForm, C Interbody System (K213359) | SeaSpine Orthopedics Corporation | 2021-12-09 |
| Disposable Medical Nitrile Examination Gloves (Model:XYS-001) (K213371) | Anhui Xinyisheng Medical Technology Co.,Ltd | 2021-12-09 |
| AirStrip ONE Web Client with Alarm Communication Management (ACM) (K211949) | Airstrip Technologies, Inc. | 2021-12-09 |
| C&B 5.0 Hybrid (K210817) | Arum Dentistry Co., Ltd. | 2021-12-08 |
| Injectable Root Canal Bioceramic Sealer (K212983) | Beijing C-Root Dental Medical Devices Co., Ltd. | 2021-12-08 |
| Disposable Medical Nitrile Examination Gloves (Non sterile) (K212639) | Jiangsu Nanfang Medical Co., Ltd. | 2021-12-08 |
| MAF Guard (K211487) | Maf Clothing Pvt Ltd Unit-3 | 2021-12-08 |
| Infrared forehead thermometer LD-FT-100B (K211629) | Honsun (Nantong) Co., Ltd. | 2021-12-08 |
| PicoLO Premium (K212573) | Laseroptek Co., Ltd. | 2021-12-08 |
| BD Nano 2nd Gen Pen Needle (K213156) | Becton, Dickinson and Company | 2021-12-08 |
| Anteralign Spinal System with Titan nanoLOCK Surface Technology (K212524) | Medtronic Sofamor Danek USA, Inc. | 2021-12-08 |
| ShurFit Lumbar Interbody System (K212075) | Precision Spine, Inc. | 2021-12-08 |
| ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20 (K211898) | Asahi Intecc Co., Ltd. | 2021-12-08 |
| DERMABOND PRINEO Skin Closure System (K213512) | ETHICON, Inc. | 2021-12-07 |
| Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42 (K213303) | Infraredx, Inc. | 2021-12-07 |
| BAYLAB 3-Ply Surgical Mask (BEACON I) (K212302) | Baylab USA, LLC | 2021-12-07 |
| Comfortpro (K212438) | Thai Rubber Industry Company Limited | 2021-12-07 |
| endomina system (K211309) | Endo Tools Therapeutics S.A. | 2021-12-07 |
| Al-Rad Companion (Pulmonary) (K213096) | Siemens Medical Solutions USA, Inc. | 2021-12-06 |
| PMW01 Procedure Mask Level 1 (K211772) | Defender Safety, Inc. | 2021-12-06 |
| Surgical Face Mask (K212235) | Shanghai Yunqing Industrial Co., Ltd. | 2021-12-06 |
| Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs (K212827) | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2021-12-06 |
| 3Delta Crown (K211804) | Deltamed GmbH | 2021-12-06 |
| VersaTap, VersaLat, DueLock, VersaTi, MiniTi (K212381) | Ortho-Design (Pty), Ltd. | 2021-12-06 |
| Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses (K211448) | Pegavision Corporation | 2021-12-06 |
| Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle (K212852) | Micro-Tech (Nanjing) Co., Ltd. | 2021-12-06 |
| LUXEN CL Dental Liquid (K212548) | Dentalmax Co., Ltd. | 2021-12-06 |
| CHENA-C Spacer System (K213115) | Kahtnu Surgical, Inc. | 2021-12-06 |
| INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) (K211561) | Covidien, LLC | 2021-12-05 |
| Nitrile Powder Free Blue Examination Gloves, Non-Sterile (K212535) | Mah Sing Healthcare Sdn. Bhd. | 2021-12-04 |
| Surgical Masks (K212807) | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2021-12-03 |
| 21HQ513D (K212295) | Lg Electronics.Inc | 2021-12-03 |
| Cydar EV (Series B) and Cydar EV Maps (K212442) | Cydar , Ltd. | 2021-12-03 |
| PVmed Contouring Software (K210916) | Perception Vision Medical Technologies Ltd.Co. | 2021-12-03 |
| AHI System (K212219) | Fifth Eye, Inc. | 2021-12-03 |
| ImplaStation (K210241) | Prodigident, Inc. | 2021-12-03 |
| Inspan ScrewLES Fusion System (K213266) | Lespine Innovations, LLC | 2021-12-03 |
| Everyway Incontinence Stimulation System (K213116) | Everyway Medical Instruments Co.,Ltd | 2021-12-03 |
| Medline Cardiovascular Procedure Kit (K212258) | Medline Industries, Inc. | 2021-12-03 |
| Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length (K213580) | Total Joint Othopedics, Inc. | 2021-12-03 |
| ArtiSential Trocar (K212500) | Livsmed, Inc. | 2021-12-03 |
| Klox Biophotonic LumiHeal System (DEN200005) | Klox Technlogies, Inc. | 2021-12-03 |
| Independent Corneal Viewing Chamber (IVC-21) (K211786) | Bausch + Lomb, Incorporated | 2021-12-03 |
| Solero Microwave Tissue Ablation (MTA) System and Accessories (K213067) | AngioDynamics, Inc. | 2021-12-03 |
| Molecular Flow Simulations (K201435) | Therataxis, LLC | 2021-12-03 |
| Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% (K210126) | The Ritedose Corporation | 2021-12-03 |
| AURORA Evacuator +Coag (K203745) | Rebound Therapeutics | 2021-12-02 |
| PS System (K211721) | Inter-Med, Inc. | 2021-12-02 |
| Aimanfun Lumea Comfort, A-2789/A-3588 (K212907) | Kam Yuen Plastic Products , Ltd. | 2021-12-02 |
| powder free nitrile examination glove - white, non-sterile (K212802) | Hong Seng Gloves Sdn Bhd | 2021-12-02 |
| Puravita Medical Fold Flat Surgical Mask (K212740) | Puravita M, LLC | 2021-12-02 |
| Single-use Surgical Mask (K211773) | Taiwan Seafood and Fish Corporation | 2021-12-02 |
| FUJIFILM Video Laparoscope EL-R740M30 (K212950) | Fujifilm Corporaton | 2021-12-02 |
| Nitrile disposable examination gloves (K212578) | Xingyu Medical Tech Co., Ltd. | 2021-12-02 |
| Encevis (K211452) | Austrian Institute of Technology GmbH | 2021-12-02 |