| MOSAIQ Oncology Information System (K203172) | Elekta Solutions AB | 2020-12-18 |
| LacriJet® (K201606) | Fci (France Chirurgie Instrumentation) Sas | 2020-12-18 |
| SQuEEZ Software (K201250) | Cardiowise, Inc. | 2020-12-18 |
| ClearRT Helical kVCT for the Radixact Treatment Delivery System (K202412) | Accuray Incorporated | 2020-12-18 |
| Fever Garde (K191978) | Hubdic Co., Ltd. | 2020-12-18 |
| microINR System (K201185) | Iline Microsystems, S.L. | 2020-12-18 |
| FlowTriever Retrieval/Aspiration System (K202345) | Inari Medical | 2020-12-18 |
| Blue Sky Bio CAD-CAM Abutments (K202026) | Blue Sky Bio, LLC | 2020-12-18 |
| Aesculap Caiman 12 Seal and Cut Technology System (K203461) | Aesculap, Inc. | 2020-12-18 |
| Invictus™ OCT Spinal Fixation System (K203125) | Alphatec Spine, Inc. | 2020-12-18 |
| UltraSlim Digital, UltraSmooth Digital (K202361) | Ward Photonics, LLC | 2020-12-18 |
| ADAPT for Gamma3 (K202749) | Stryker GmbH | 2020-12-18 |
| S10 Kirra (K203126) | Resmed Pty , Ltd. | 2020-12-18 |
| IdentiTi Cervical Standalone Interbody System (K202812) | Alphatec Spine, Inc. | 2020-12-18 |
| ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System (K202006) | ArthroCare Corporation | 2020-12-18 |
| BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter (K201075) | Becton, Dickinson and Company | 2020-12-18 |
| EchoGo Pro (K201555) | Ultromics, Ltd. | 2020-12-18 |
| Infrared Thermometer (K201980) | Contec Medical Systems Co.,Ltd | 2020-12-18 |
| Advanix Biliary Stent with NaviFlex RX Delivery System (K203162) | Boston Scientific Corporation | 2020-12-18 |
| Alphenix, INFX-8000V/B, /S, V9.1 (K203551) | Canon Medical Systems Corporation | 2020-12-18 |
| ARx Illiac Spinal Screw System (K203163) | Life Spine, Inc. | 2020-12-17 |
| KARL STORZ ICG Imaging System (K202925) | Karl Storz Endoscopy_America, Inc. | 2020-12-17 |
| Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Use Grasping Forceps FG-232L, Single Use Grasping Forceps FG-804L (K200342) | Olympus Medical Systems Corp. | 2020-12-17 |
| Electric wheelchair (Model: S7012) (K200857) | Dongguan Prestige Sporting Goods Co., Ltd. | 2020-12-17 |
| PERLA TL Posterior Osteosynthesis System (K203222) | Spineart | 2020-12-17 |
| Wrist Type Blood Pressure Monitor (K200346) | Avita Corporation | 2020-12-17 |
| Blue Sky Bio TAD (K201919) | Blue Sky Bio, LLC | 2020-12-17 |
| In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath (K201165) | Coloplast Corp. | 2020-12-17 |
| S dispensing line (K192770) | Aea Srl | 2020-12-17 |
| SMR 140° Reverse Humeral Body (K201905) | Lima Corporate S.P.A. | 2020-12-17 |
| ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System (K203004) | Acist Medical Systems, Inc. | 2020-12-17 |
| Primelase Excellence (K201594) | High Technology Products S.L.U | 2020-12-17 |
| Aidite PMMA (K190217) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2020-12-17 |
| pjur WOMAN Nude pjur med SENSITIVE glide (K200730) | Pjur Group Luxembourg S.A. | 2020-12-17 |
| Emprint SX Ablation Platform with Thermosphere Technology (K203303) | Covidien, LLC | 2020-12-17 |
| Exofin High Viscosity Topical Skin Adhesive (K200264) | Chemence Medical, Inc. | 2020-12-17 |
| AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter (K201081) | Philips Medical System Nederland B.V. | 2020-12-17 |
| Disposable Stone Extraction basket (K201509) | Hangzhou AGS MedTech Co., Ltd. | 2020-12-16 |
| BEAR (Bridge-Enhanced ACL Repair) Implant (DEN200035) | Miach Orthopaedics, Inc. | 2020-12-16 |
| DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System (K203414) | DePuy Synthes | 2020-12-16 |
| Arthrex DynaNite Nitinol Staples (K203180) | Arthrex, Inc. | 2020-12-16 |
| NRFit® Caps, Male and Female Neuraxial Tip Caps (K201031) | International Medical Industries, Inc. | 2020-12-16 |
| CREED™ Cannulated Screws (K200291) | Glw Medical, Inc. | 2020-12-16 |
| Medical Surgical Mask (K202029) | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2020-12-16 |
| CreoDent Solidex Customized Abutment and Screw (K202095) | Creodent Prosthetics, Ltd. | 2020-12-16 |
| dermalux Flex MD (K202028) | Aesthetic Technology, Ltd. | 2020-12-16 |
| HydroMARK Breast Biopsy Site Markers (K203097) | Devicor Medical Products, Inc. | 2020-12-16 |
| Pasteur Pipette 3mL, Pasteur Pipette 1mL (K201213) | Hertart Aps | 2020-12-16 |
| Longeviti ClearFit Cranial Implant (K203349) | Longeviti Neuro Solutions, LLC | 2020-12-16 |
| ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) (K202289) | Stryker GmbH | 2020-12-16 |
| Lucero Medical Cervical Cage System (K200549) | Lucero Medical, LLC | 2020-12-16 |
| WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System (K201755) | SeaSpine Orthopedics Corporation | 2020-12-15 |
| Single-use Sterile medical laser fiber (K202601) | Realton (Suzhou) Medical Technology Co., Ltd. | 2020-12-15 |
| Lim Precision Steerable TS, Steerable Sheath, Dilator (K202226) | Keystone Heart, Ltd. | 2020-12-15 |
| Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62 (K203383) | Philips Consumer Lifestyle - Innovation Site Eindhoven | 2020-12-15 |
| 308nm Excimer UV-light Skin Therapy System (K202827) | Shenzhen Gsd Tech Co., Ltd. | 2020-12-15 |
| 308nm Excimer System (K200971) | Xuzhou Kernel Medical Equipment Co., Ltd. | 2020-12-15 |
| NEXXT MATRIXX Stand Alone ALIF System (K202230) | Nexxt Spine, LLC | 2020-12-15 |
| Neocis Guidance System (NGS) with Patient Splints (EPS) (K203401) | Neocis, Inc. | 2020-12-15 |
| Fixone All Suture Anchor (K192709) | Aju Pharm Co., Ltd. | 2020-12-15 |
| Pulsed electromagnetic field wrap (K202337) | Hi-Dow International, Inc. | 2020-12-15 |
| Prefilled Syringe (K202698) | Hangzhou Primecare Medical Co., Ltd. | 2020-12-15 |
| X-Tack Endoscopic HeliX Tacking System (K201808) | Apollo Endosurgery, Inc. | 2020-12-15 |
| Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use (K201284) | Set Medikal Sanayi VE Ticaret Anonim Sirketi | 2020-12-14 |
| DNA/RNA Shield Collection Tube (K202641) | Zymo Research | 2020-12-14 |
| Maxxi Flow Sensor (K201495) | Neurovirtual USA, Inc. | 2020-12-14 |
| Javelin Tailor's Bunion Fixation System (K202657) | Nvision Biomedical Technologies, Inc. | 2020-12-14 |
| Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (K202467) | Fengh Medical Co., Ltd. | 2020-12-14 |
| Physica system (K201084) | Lima Corporate S.P.A. | 2020-12-14 |
| Irrisept Wound Debridement and Cleansing System (K202222) | Irrimax Corporation | 2020-12-14 |
| Columbus Guidewire (K200374) | Rapid-Medical , Ltd. | 2020-12-14 |
| PlaDuo System (K201735) | ShenB Co., Ltd. | 2020-12-14 |
| Medical Face Mask (K201629) | Shandong Shengquan New Material Co., Ltd. | 2020-12-14 |
| Fingertip Pulse Oximeter (K202324) | Shenzhen Bsx Technology Electronics Co., Ltd. | 2020-12-14 |
| Ventrax Delivery System (K202610) | Merit Medical Systems, Inc. | 2020-12-14 |
| ELEOS Limb Salvage System featuring BIOGRIP (K203090) | Onkos Surgical | 2020-12-11 |
| NOVA Lite DAPI dsDNA Crithidia luciliae Kit (K192916) | Inova Diagnostics, Inc. | 2020-12-11 |
| 3M Comply Hydrogen Peroxide Chemical Indicator 1248 (K203458) | 3M Company | 2020-12-11 |
| Automated ankle brachial pressure index measuring device, MESI mTABLET system (K201046) | Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. | 2020-12-11 |
| CorPath GRX System (K202275) | Corindus, Inc. | 2020-12-11 |
| Hamilton-C6 (K201658) | Hamilton Medical AG | 2020-12-11 |
| exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft (K202471) | Peca Labs | 2020-12-11 |
| BeamSite (K200940) | Doseoptics, LLC | 2020-12-11 |
| Drakon and Sequre Microcatheters (K203487) | Accurate Medical Therapeutics, Ltd. | 2020-12-11 |
| TENS & PMS (K201354) | Hong Qiangxing (Shenzhen) Electronics Limited | 2020-12-11 |
| 3M Attest Rapid Readout Biological Indicator (K200996) | 3M Company | 2020-12-11 |
| GMK Total Knee System - TiNbN Coating (K202684) | Medacta International S.A. | 2020-12-11 |
| JADE (K202231) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2020-12-10 |
| AquaPulse Irrigation Tubing (K202560) | Ga Health Company Limited | 2020-12-10 |
| Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration (K200376) | Navbit Pty, Ltd. | 2020-12-10 |
| PROFEMUR® GLADIATOR® Cemented Classic Stem (K201519) | Microport Orthopedics, Inc. | 2020-12-10 |
| Neuronaute (K202334) | Bioserenity Sas | 2020-12-10 |
| da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) (K202834) | Intuitive Surgical, Inc. | 2020-12-10 |
| Triever20 Curve Catheter (K203333) | Inari Medical, Inc. | 2020-12-10 |
| Posterior Fusion Plate, HA Posterior Fusion Plate (K200066) | Spinal Simplicity, LLC | 2020-12-10 |
| MY01 Continuous Compartmental Pressure Monitor (K202635) | MY01, Inc. | 2020-12-10 |
| X-cera Pre-shaded Zirconia Blanks (K202673) | Dongguan Xiangtong Co., Ltd. | 2020-12-10 |
| Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I (K203042) | Canon Medical Systems Corporation | 2020-12-10 |
| Deep Learning Image Reconstruction for Gemstone Spectral Imaging (K201745) | Ge Medical Systems, LLC | 2020-12-10 |
| Zimmer Segmental System (K192798) | Zimmer, Inc. | 2020-12-10 |