| Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey) (K201530) | Hartalega NGC Sdn. Bhd. | 2020-08-05 |
| Aurora® Anterior Lumbar Plate Sytstem (K201079) | Prism Surgical Design Pty , Ltd. | 2020-08-05 |
| Adaptive Biotechnologies clonoSEQ Assay (K200009) | Adaptive Biotechnologies Corporation | 2020-08-05 |
| PlasmaFlight (K200351) | Manamed, Inc. | 2020-08-05 |
| CarboClear Navigated Instruments (K201251) | CarboFix Orthopedics , Ltd. | 2020-08-05 |
| Enhanced External Counter Pulsation Device Plus Omay-A (K191955) | Omay(Guangzhou)Med Technologies Co., Ltd. | 2020-08-05 |
| Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) (K201531) | Hartalega Sdn Bhd | 2020-08-05 |
| Mariner Cap System (K201240) | SeaSpine Orthopedics Corporation | 2020-08-05 |
| ECG Monitor App (K201168) | Samsung Electronics Co., Ltd. | 2020-08-04 |
| CureOs TCP (K191670) | Linacol Muh Dan Kim Cev Tek Med Ith Ihr San VE Tic | 2020-08-04 |
| Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer (K201500) | Life Spine, Inc. | 2020-08-04 |
| ETD Family of Electrotherapy Devices (K201958) | Therasigma, LLC | 2020-08-04 |
| Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) – Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff (K193666) | Medline Industries, Inc. | 2020-08-04 |
| HemoCue Hb 301 System (K201217) | Hemocue AB | 2020-08-04 |
| Corin Optimized Positioning System (OPS) Femoral (K193545) | Corin USA | 2020-08-04 |
| CoFix System (K201704) | Paradigm Spine GmbH | 2020-08-04 |
| HYPER DLR (K193210) | Shanghai United Imaging Healthcare Co., Ltd. | 2020-08-04 |
| Vector Hammertoe Correction System (K201850) | Nvision Biomedical Technologies, Inc. | 2020-08-04 |
| Glaucoma Module (K200954) | Topcon Healthcare Solutions, Inc. | 2020-08-03 |
| Vesco Medical Extension Feeding Set (K192991) | Vesco Medical, LLC | 2020-08-03 |
| Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter (K192712) | Medtronic, Inc. | 2020-08-03 |
| Electrodes Handpieces for Mygen V-1000 RF System (K193355) | RF Medical Co., Ltd. | 2020-08-03 |
| EyeArt (K200667) | Eyenuk, Inc. | 2020-08-03 |
| Arm-Type Fully Automatic Digital Blood Pressure Monitor (K200649) | Joytech Healthcare Co. , Ltd. | 2020-08-03 |
| Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers (K201442) | Diatron Group | 2020-07-31 |
| P pro Crown & Bridge (K200039) | Deltamed GmbH | 2020-07-31 |
| xPORT 304 (miCOR) System Lens Fragmentation System (K200584) | Carl Zeiss Meditec Cataract Technology, Inc. | 2020-07-31 |
| BiPad Hand Activated, Disposable Bipolar Electrocautery Cords (K201833) | Bipad Surgical, Inc. | 2020-07-31 |
| Reprocessed Endoscopic Trocars and Sleeves (K201511) | Stryker Sustainability Solutions | 2020-07-31 |
| Flex Fit (K190790) | Dk Mungyo Corporation | 2020-07-31 |
| Navigation Enabled Intruments (K200791) | Medos International SARL | 2020-07-31 |
| CORBEL Spacers (K201087) | Globus Medical, Inc. | 2020-07-31 |
| Kendall NPWT Incision Management Dressing Kit (K191101) | Cardinalhealth | 2020-07-31 |
| VibrantVue Scleral Saline (K201069) | Dry Eye Innovations, LLC | 2020-07-31 |
| BEAR and BEAR mini (K200803) | Foreo, Inc. | 2020-07-31 |
| Liver Incytes, Model 1005 (K201597) | Sonic Incytes | 2020-07-31 |
| Clear Guide SCENERGY (K201898) | Clear Guide Medical | 2020-07-31 |
| UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge (K201837) | Neotract, Inc. | 2020-07-31 |
| Cyber Blade (K192499) | SIDAM S.r.l. | 2020-07-31 |
| Carto Octaray Mapping Catheter with Trueref Technology (K193237) | Biosense Webster, Inc. | 2020-07-31 |
| Cemented Origin Hip Stem (K201951) | Signature Orthopaedics Pty, Ltd. | 2020-07-31 |
| I Do (K192294) | I DO Biotech Co., Ltd. | 2020-07-31 |
| AI-Rad Companion Prostate MR (K193283) | Siemens Medical Solutions USA, Inc. | 2020-07-30 |
| MAGEC® System (K201543) | Nuvasive Specialized Orthopedics, Inc. | 2020-07-30 |
| BD Univia RightFit Enteral Extension Sets and Transitional Adapters (K200082) | Mps Medical, Inc. | 2020-07-30 |
| S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System (K201059) | Sonoscape Medical Corp. | 2020-07-30 |
| MEDRAD Imaging Bulk Package Transfer Spike (K200280) | Bayer Medical Care, Inc. | 2020-07-30 |
| Sterispine™ PS (K201648) | Safe Orthopaedics | 2020-07-30 |
| Joimax Intracs System (K192663) | Joimax GmbH | 2020-07-30 |
| KY Grosz Jelly (K201186) | Rb Health (Us), LLC | 2020-07-30 |
| SpeediCath Soft (K200142) | Coloplast | 2020-07-30 |
| MY01 Continuous Compartmental Pressure Monitor (K193321) | MY01, Inc. | 2020-07-30 |
| cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit (DEN200015) | Roche Molecular Systems, Inc. | 2020-07-30 |
| Safey Pocket Spirometer (K201002) | Safey Medical Devices Pvt, Ltd. | 2020-07-30 |
| OSSIOfiber™ Compression Screws (K193660) | OSSIO , Ltd. | 2020-07-30 |
| EXULT Femoral component trial - Left, EXULT Femoral component trial - Right (K201851) | Corentec Co., Ltd. | 2020-07-30 |
| Arthrex Mini Hip PushLock (K201786) | Arthrex, Inc. | 2020-07-30 |
| HI-TORQUE PROCEED Guide Wire Family (K201834) | Abbott Vascular | 2020-07-30 |
| Safey Peak Flow Meter (K200832) | Safey Medical Devices Pvt, Ltd. | 2020-07-30 |
| Reprocessed NRG Transseptal Needle (K200060) | Innovative Health, LLC | 2020-07-30 |
| FractureDetect (FX) (K193417) | Imagen Technologies, Inc. | 2020-07-30 |
| PENTAX Medical Video Bronchoscope EB-J10 Series (K200678) | Pentax of America, Inc. | 2020-07-30 |
| Pitkar External Fixation System - Rail Mechanism (K200518) | S.H.Pitkar Orthotools Pvt. , Ltd. | 2020-07-29 |
| Symphony (K200413) | Aroa Biosurgery , Ltd. | 2020-07-29 |
| Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling (K200959) | Biomet UK, Ltd. | 2020-07-29 |
| BoniPlus Dental G-Mesh System (K182759) | Montjade Engineering Co., Ltd. | 2020-07-29 |
| Bioflux Software II (K201040) | Biotricity | 2020-07-29 |
| Superpipe Angiographic Catheter (K193647) | Suzhou Hengrui Disheng Medical Co., Ltd. | 2020-07-29 |
| PNEUMOCLEAR (K201361) | W.O.M. World of Medicine GmbH | 2020-07-29 |
| Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown (K200824) | Cardinal Health200, LLC | 2020-07-29 |
| Zoom 14 Guidewire (K201760) | Scientia Vascular, LLC | 2020-07-29 |
| BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote (K200504) | Med-El Elektromedizinische Geraete GmbH | 2020-07-29 |
| Jade (K201794) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2020-07-28 |
| TRUSELECT Microcatheter (K201792) | Boston Scientific Corporation | 2020-07-28 |
| Connected OR Hub with Voice Control, Connected OR Hub with Device Control (K201434) | Stryker | 2020-07-28 |
| SyMRI (K201616) | Syntheticmr AB | 2020-07-28 |
| AccelFix Lumbar Plate System (K192481) | L&K BIOMED Co., Ltd. | 2020-07-28 |
| Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type) (K192681) | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2020-07-28 |
| Quantisal Oral Fluid Collection Device (K200801) | Immunalysis Corporation | 2020-07-28 |
| Neocis Guidance System (NGS) with Patient Splints (K200805) | Neocis, Inc. | 2020-07-28 |
| Arthrex Compression Screws (K201132) | Arthrex, Inc. | 2020-07-27 |
| StaClear Syringe (K200242) | Tribofilm Research, Inc. | 2020-07-27 |
| Stratum™ Reduced Size Foot Plating System (K200785) | Nextremity Solutions, Inc. | 2020-07-27 |
| Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed (K201280) | Ethicon Endo-Surgery, LLC | 2020-07-27 |
| Vitalograph Model 2120 In2itive eDiary (K200550) | Vitalograph Ireland, Ltd. | 2020-07-27 |
| Aer X (K200496) | 3B Medical, Inc. | 2020-07-24 |
| Extremely Thin 003, ZERO ZERO THREE (K192669) | Okamoto USA, Inc. | 2020-07-24 |
| Arthrex SutureTape (K193575) | Arthrex, Inc. | 2020-07-24 |
| Ureterorenoscope System (K201293) | Shanghai AnQing Medical Instrument Co., Ltd. | 2020-07-24 |
| Disposable Temperature Probe (K193625) | Shenzhen Changke Connect Electronics Co., Ltd. | 2020-07-24 |
| Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous (K200643) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-07-24 |
| DemeMASK (K201479) | Demetech Corporation | 2020-07-24 |
| Tempus LS - Manual (K200849) | Remote Diagnostic Technologies, Ltd. A Philips Company | 2020-07-24 |
| JUSHA-CP610 LCD Monitor (K200742) | Nanjing Jusha Display Technology Co., Ltd. | 2020-07-24 |
| Single Use Electrosurgical Knife (K193601) | Micro-Tech (Nanjing) Co., Ltd. | 2020-07-24 |
| DePuy Synthes 2.7mm VA LCP Clavicle Plate System (K201321) | DePuy Synthes | 2020-07-24 |
| Transept Cervical Plate System (K200927) | Neurostructures, Inc. | 2020-07-24 |
| 1717SCV, 1717SGV (K201796) | Rayence Co., Ltd. | 2020-07-23 |
| AVVIGO Guidance System (K201713) | Boston Scientific Corporation | 2020-07-23 |
| Canon non-mydriatic retinal camera CR series (K201122) | Canon, Inc. | 2020-07-23 |