| TiUltra Implants and Xeal Abutments (K202344) | Nobel Biocare AB | 2020-11-16 |
| Freeprint denture (K200461) | Detax GmbH & Co. KG | 2020-11-16 |
| Circular Fixation with Balanced Cable Transport (K202762) | Smith & Nephew, Inc. | 2020-11-16 |
| Nd: YAG Laser Therapy Systems HM-YL900 (K202758) | Shangdong Huamei Technology Co., Ltd. | 2020-11-16 |
| Ion Endoluminal System (K202370) | Intuitive Surgical, Inc. | 2020-11-16 |
| Cordiana Dx16 (K201060) | Cordiana Medical Informatics AG | 2020-11-16 |
| Avid CT2 (K202490) | Vision Quest Industries Inc./Dba VQ Orthocare | 2020-11-16 |
| MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL ) (K202343) | Beckman Coulter, Inc. | 2020-11-16 |
| Sientra OPUS Silicone Gel Breast Implant Sizer (K200706) | Sientra, Inc. | 2020-11-16 |
| M.U.S.T. MINI Posterior Cervical Screws System (K203149) | Medacta International S.A. | 2020-11-16 |
| EVOS Large Fragment Plating System (K201918) | Smith & Nephew, Inc. | 2020-11-16 |
| Telio CAD Abutment Solutions- extra systems (K193193) | Ivoclar Vivadent, AG | 2020-11-16 |
| Apogee (K200401) | Incoba Ltd D/B/A Dynaris | 2020-11-14 |
| Stryker Omega PEEK Knotless Anchor System (K202355) | Stryker | 2020-11-13 |
| Astroglide Organix Gel (K200239) | Biofilm, Inc. | 2020-11-13 |
| Acumen Assisted Fluid Management (AFM) Software Feature (DEN190029) | Edwards Lifesciences | 2020-11-13 |
| Kerecis Gingiva Graft (K192612) | Kerecis Limited | 2020-11-13 |
| CoroFlow Cardiovascular System (K201881) | Coroventis Research AB | 2020-11-13 |
| Monster Screw System (K203011) | Paragon 28, Inc. | 2020-11-13 |
| Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 (K202317) | Everyway Medical Instruments Co.,Ltd | 2020-11-13 |
| FlexCath Advance Steerable Sheath and Dilator (K202620) | Medtronic Cryocath, LP | 2020-11-13 |
| Ceramir Restore QuikCap (K201937) | Doxa Dental AB | 2020-11-13 |
| APEX 3D Total Ankle Replacement System (K202373) | Paragon 28, Inc. | 2020-11-13 |
| Venue (K202132) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-11-13 |
| VersaLoop Anchor System (K202178) | T.A.G. Medical Products Corporation, Ltd. | 2020-11-13 |
| SpeediCath Compact Set (K200820) | Coloplast | 2020-11-13 |
| NEUWAVE Microwave Ablation System and Accessories (K200081) | Neuwave Medical, Inc. | 2020-11-13 |
| SIGNA Architect (K202966) | Ge Healthcare (Ge Medical Systems, LLC) | 2020-11-13 |
| TSolution One Total Knee Application (K203040) | THINK Surgical, Inc. | 2020-11-13 |
| SINGLE USE MANOMETER (K201666) | Flexicare Medical Limited. | 2020-11-13 |
| Insight Infrared Video Goggles (K203082) | Vestibular First | 2020-11-12 |
| da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories (K202571) | Intuitive Surgical, Inc. | 2020-11-12 |
| TP Orthodontics Clear Aligner System (K193385) | Tp Orthodontics, Inc. | 2020-11-12 |
| EOGas 4 Ethylene Oxide Gas Sterilizer (K192978) | Andersen Sterilizers, Inc. | 2020-11-12 |
| AGILON® XO Shoulder Replacement System (K191433) | Implantcast GmbH | 2020-11-12 |
| Apache Ultrasound System (Model C62) (K202074) | Compal Electronics, Inc. | 2020-11-12 |
| NOVA Patient Warming System (K203085) | Encompass Group, LLC | 2020-11-12 |
| AN1036 Dosimeter (K200334) | Andersen Sterilizers, Inc. | 2020-11-12 |
| FastStroke, CT Perfusion 4D (K193289) | GE Medical Systems SCS | 2020-11-12 |
| Calvary Spine Pedicle Screw System (K201568) | Calvary Spine, LLC | 2020-11-12 |
| ExacTrac Dynamic (K203173) | Brainlab AG | 2020-11-12 |
| EOGas 4 Endo-SteriTest (K192980) | Andersen Sterilizers, Inc. | 2020-11-12 |
| KardiaAI (K201985) | AliveCor, Inc. | 2020-11-12 |
| Tyvek Sterilization Pouches with Chevron Seal (K200336) | Andersen Sterilizers, Inc. | 2020-11-12 |
| Sterisheet Sterilization Wrap (K200335) | Andersen Sterilizers, Inc. | 2020-11-12 |
| O2asis Personal Oxygen Humidifier (K193411) | Perma Pure, LLC | 2020-11-12 |
| Sharps container (K201523) | Zhejiang Gongdong Medical Technology Co., Ltd. | 2020-11-12 |
| Route 92 Medical 070 Access System (K203043) | Route 92 Medical, Inc. | 2020-11-11 |
| StimSite (K200886) | Allotrope Medical, Inc. | 2020-11-10 |
| SnapshotNIR (K201976) | Kent Imaging | 2020-11-10 |
| Nio Fusion 12MP (MDNC-12130) (K203106) | Barco N.V. | 2020-11-10 |
| VagiVital Aktivgel (K200098) | Peptonic Medical AB | 2020-11-10 |
| WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws (K193214) | Biomet, Inc. | 2020-11-10 |
| Multi-Drive Interference Screw System (K200428) | Nvision Biomedical Technologies, Inc. | 2020-11-10 |
| JTK Dental Implant System (K183044) | Jiangyin Jintech Biotech Co., Ltd. | 2020-11-10 |
| Accula Strep A Test (K201269) | Mesa Biotech, Inc. | 2020-11-09 |
| DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound System (K201990) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-11-09 |
| iFuse Implant System - iFuse Navigation (K203110) | SI-BONE, Inc. | 2020-11-09 |
| EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS (K203128) | Olympus Medical Systems Corp. | 2020-11-09 |
| BD PureHub Disinfecting Cap (K193190) | Becton, Dickinson and Company | 2020-11-09 |
| Vantage PSI System (K193432) | 3D Systems | 2020-11-09 |
| Concinnity Aligners (K200005) | Drake Precision Dental Laboratory, Inc. | 2020-11-09 |
| Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits (K202274) | Boston Scientific Neuromodulation | 2020-11-09 |
| OGYILI TENS/NMES Stimulator (K201431) | Gongguan Tutamen Metalwork Co., Ltd. | 2020-11-09 |
| Medical RF (K192621) | Triworks Group Srl | 2020-11-06 |
| cobas u 701 microscopy analyzer (K200811) | Roche Diagnostics | 2020-11-06 |
| V-Print splint (K201091) | Voco GmbH | 2020-11-06 |
| Aqueduct 100 Plus Cervical Dilation Balloon Catheter (K202427) | Gtimd, LLC | 2020-11-06 |
| BioShield biopsy valve EUS - Linear (K202583) | STERIS Corporation | 2020-11-06 |
| Neuro.Al Algorithm (K200750) | Terarecon,Inc. | 2020-11-06 |
| APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System (K202589) | Medartis AG | 2020-11-06 |
| Mecta-C Stand Alone Extension (K203076) | Medacta International S.A. | 2020-11-06 |
| ATEC Lateral Interbody System (K202587) | Alphatec Spine, Inc. | 2020-11-06 |
| Clio Prime and Clio Pedo (K202664) | Sota Precision Optics, Inc. Dba Sota Imaging | 2020-11-06 |
| BioMin Restore Plus (K200077) | Dr. Collins, Inc. | 2020-11-06 |
| Durex Penck Standard, Durex Penck XL (K200672) | Rb Health (Us), LLC | 2020-11-06 |
| NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable (DEN200033) | Nightware, Inc. | 2020-11-06 |
| SimpleSENSE (K201669) | Nanowear, Inc. | 2020-11-06 |
| AI-Rad Companion Organs RT (K193562) | Siemens Medical Solutions USA, Inc. | 2020-11-06 |
| Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-600 and HC-1500),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-800 and HC-1000),Evolution Automated Loading and Unloading System (ALUS) (K203061) | STERIS Corporation | 2020-11-06 |
| KASILOF Cervical Plate System (K203154) | Kahtnu Surgical, Inc. | 2020-11-05 |
| Salvo® Spine System (K202476) | Spine Wave, Inc. | 2020-11-05 |
| Eclipse DermaFlex Cannula (K200017) | Eclipse Medcorp, LLC | 2020-11-05 |
| Gabriel 3 Way EnFit Valve (K201741) | Syncro Medical Innovations, Inc. | 2020-11-05 |
| LOBO Vascular Occlusion System (model LOBO-5) (K203025) | Okami Medical | 2020-11-05 |
| MammaPrint (K201902) | Agendia, Inc. | 2020-11-05 |
| GR-17 Resin System (K201827) | Pro3Dure Medical GmbH | 2020-11-05 |
| SPY-PHI System with SPY-PHI Fluorescence Assessment Software (K202244) | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2020-11-05 |
| OtoSet- Ear Cleaning System (K201877) | Safkan, Inc. | 2020-11-05 |
| Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) (K201840) | Rebound Therapeutics | 2020-11-04 |
| Sweden & Martina Surgical Tray (Model ZSHORTY-INT) (K182084) | Sweden & Martina S.P.A. | 2020-11-04 |
| Z-Span Plate System (K202624) | Zavation Medical Products, LLC | 2020-11-04 |
| Monitor B125, Monitor B105 (K201941) | Ge Medical Systems Information Technologies, Inc. | 2020-11-04 |
| DigiGuide System (K193499) | Protomed, Inc. | 2020-11-04 |
| MyHip Planner & Verifier (K200350) | Medacta International S.A. | 2020-11-04 |
| Arthrex TightRope II (K202581) | Arthrex, Inc. | 2020-11-04 |
| Arietta 65 (K202422) | Hitachi Healthcare Americas | 2020-11-04 |
| FlareHawk Interbody Fusion System (K202198) | Integrity Implants, Inc. | 2020-11-03 |
| PMMA Block (K201683) | Huge Dental Material Co., Ltd. | 2020-11-03 |
| Palm NRG cellulite and muscle toning body device (K191940) | Heat IN A Click | 2020-11-03 |