| MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System (K200001) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-04-09 |
| hyperion X5, NewTom GO, X-RADiUS COMPACT (K200688) | Cefla S.C. | 2020-04-09 |
| Arrow FiberOptix Intra-Aortic Balloon Catheter Kit (K200634) | Arrow International, Inc. | 2020-04-09 |
| ATLAS Plating System (K191867) | MiRus, LLC | 2020-04-09 |
| Standard Trocar (K200517) | Standard Bariatrics | 2020-04-09 |
| CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System (K200052) | Orthofix, Inc. | 2020-04-09 |
| Unified Arrhythmia Diagnostic System PocketECG IV (K193104) | Medicalgorithmics S.A. | 2020-04-09 |
| Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags (K200630) | Medtronic, Inc. | 2020-04-09 |
| Nautilus Smart ECMO Module (K191935) | Mc3 Incorporated | 2020-04-09 |
| PreXion3D Explorer EX (K193329) | Prexion Corporation | 2020-04-09 |
| ClearCalc (K193640) | Radformation, Inc. | 2020-04-09 |
| OxSAT 100 (K191574) | S.L.P. , Ltd. | 2020-04-09 |
| Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (K200539) | Sri Trang Gloves (Thailand) Public Company Limited | 2020-04-09 |
| Powder Free Nitrile Examination Glove (Aqua Green) (K200326) | Riverstone Resources Sdn Bhd | 2020-04-09 |
| EchoNavigator (K200713) | Philips Medical Systems Nederland B.V. | 2020-04-09 |
| Standard Bougie (K191885) | Standard Bariatrics | 2020-04-08 |
| Panthera Dental Milled Bars (K192108) | Panthera Dental, Inc. | 2020-04-08 |
| AIMI-Triage CXR PTX (K193300) | Radlogics, Inc. | 2020-04-08 |
| HI-TORQUE Steelcore Bare Guide Wire (K200144) | Abbott Vascular | 2020-04-08 |
| Voyant Maryland Fusion Device (K200598) | Applied Medical Resources Corp. | 2020-04-08 |
| Orfit Aerial Couchtop (K200282) | Orfit Industries NV | 2020-04-08 |
| TCAT TKA Instrument Tray Set (K200632) | THINK Surgical, Inc. | 2020-04-08 |
| Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System (K200411) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-04-08 |
| TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large) (K192636) | Medtronic, Inc. | 2020-04-08 |
| Go2Wire Guide Wire (K193571) | Merit Medical System, Inc. | 2020-04-08 |
| Flex Body Speeder (K200477) | Quality Electrodynamics, LLC | 2020-04-08 |
| BD Centro Vena Acute Central Line (7 French Dual Lumen) (K200266) | Bard Access Systems, Inc. (Bard Has Joined Bd) | 2020-04-07 |
| BlueStar Rx (K193654) | Welldoc, Inc. | 2020-04-07 |
| The Optimotion Blue Total Knee System (K191084) | Optimotion Implants, LLC | 2020-04-07 |
| Innovision Audio (K193218) | Innovere Medical, Inc. | 2020-04-07 |
| HS40 Diagnostic Ultrasound System (K200339) | Samsung Medison Co., Ltd. | 2020-04-07 |
| VERTICALE® Cervical System (K192013) | Silony Medical GmbH | 2020-04-07 |
| Stat Profile Prime Plus Analyzer System (K200204) | Nova Biomedical Corporation | 2020-04-06 |
| Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit (K200023) | Gold Standard Diagnostics | 2020-04-06 |
| Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black) (K200019) | Hartalega NGC Sdn. Bhd. | 2020-04-06 |
| Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter (K192558) | Mivi Neurovascular | 2020-04-06 |
| Irrigation Tubing with CO2 or Air (K193250) | Keymed (Medical and Industrial Equipment) , Ltd. | 2020-04-06 |
| Origin™ Anterior Cervical Plate System (K193494) | Orthopaedic & Spine Development | 2020-04-06 |
| Diode Laser Hair Removal System (K191970) | Beijing Sano Laser S&T Development Co.,Ltd | 2020-04-06 |
| ClearMask Transparent Surgical Face Mask (K200576) | Clearmask, LLC | 2020-04-06 |
| Tryptik Ti (K200312) | Spineart | 2020-04-06 |
| Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit (K200025) | Gold Standard Diagnostics | 2020-04-06 |
| Akros Scruture Anchor LisFranc Repair Kit (K200361) | Akros Medical | 2020-04-06 |
| Straumann Screw-Retained Abutments (K192401) | Straumann USA, LLC | 2020-04-06 |
| SensiCare PI and SensiCare PI Micro Surgical Gloves (K193217) | Medline Industries, Inc. | 2020-04-06 |
| Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer (K192500) | Honsun (Nantong) Co., Ltd. | 2020-04-06 |
| Neural Navigator (K191422) | Soterix Medical, Inc. | 2020-04-06 |
| Eko CORE (K200776) | Eko Devices, Inc. | 2020-04-06 |
| MTS Lefamulin 0.016- 256 µg/mL (K200308) | Liofilchem S. R. 1. | 2020-04-06 |
| ADVIA Centaur CA 125II (K200199) | Siemens Healthcare Diagnostics, Inc. | 2020-04-06 |
| FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System (K200022) | Livermoretech, Inc. | 2020-04-03 |
| LAP-iX Suction Irrigation (K200638) | Sejong Medical Co., Ltd. | 2020-04-03 |
| RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector (K200577) | STERIS Corporation | 2020-04-03 |
| Visera Elite II Video System Center, Visera Elite II Endoeye 3D (K193026) | Olympus Medical Systems Corp. | 2020-04-03 |
| ADAPT Tissue (K200566) | Admedus Regen Pty, Ltd. | 2020-04-03 |
| Faico Dental Implant System (K192015) | Faico Medical, LLC | 2020-04-03 |
| Aria System (K200564) | Inova Labs | 2020-04-03 |
| Eclipse Treatment Planning System v16.0 (K200608) | Varian Medical Systems, Inc. | 2020-04-03 |
| Diode Laser Hair Removal Machine (K192735) | Beijing Lead Beauty S & T Co., Ltd. | 2020-04-03 |
| Osom Ultra Plus Flu A&B Test Kit (K192719) | SEKISUI Diagnostics, LLC | 2020-04-03 |
| Medone Ultra, Medextra (K192101) | Medax Srl Unipersonale | 2020-04-02 |
| IntelePACS (K192176) | Intelerad Medical Systems Incorporated | 2020-04-02 |
| Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System (K200251) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-04-02 |
| NovaCross CTO Microcatheter (K193322) | Nitiloop , Ltd. | 2020-04-02 |
| CS Model+ (K193390) | Trophy | 2020-04-02 |
| FIREBIRD SI Fusion System (K200696) | Orthofix, Inc. | 2020-04-02 |
| FilmArray BCID2 Control Panel M416 (K200010) | Maine Molecular Quality Controls, Inc. | 2020-04-02 |
| ARC 400 (K193591) | Bowa-Electronics GmbH & Co. KG | 2020-04-02 |
| MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System (K192099) | Medax Srl Unipersonale | 2020-04-02 |
| EVOS Lumbar Interbody System (K200552) | Cutting Edge Spine, LLC | 2020-04-02 |
| TwitchView System (K192958) | Blink Device Company | 2020-04-02 |
| Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French (K193027) | Deroyal Industries, Inc. | 2020-04-02 |
| SIRION Lateral Lumbar Interbody System (K192006) | Astura Medical, LLC | 2020-04-02 |
| HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable (K200319) | Deroyal Industries, Inc. | 2020-04-02 |
| SYMPHONY™ OCT System (K192646) | Medos International SARL | 2020-04-02 |
| QwikCheck Chemical Indicators (K192445) | Serim Research Corporation | 2020-04-02 |
| Patient Monitor (K192514) | Edan Instruments, Inc. | 2020-04-02 |
| Ambu aScope 4 Cysto (K193095) | Ambu A/S | 2020-04-02 |
| Magnetic Surgical System (K191762) | Levita Magnetics International Corp | 2020-04-01 |
| CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant (K192228) | Cs Medical, LLC | 2020-04-01 |
| Introcan Safety 2 IV Catheter 18-24 gauge (K192676) | B.Braun Medical, Inc. | 2020-04-01 |
| Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use (K192988) | Medline Industries, Inc. | 2020-04-01 |
| LOGIQ E10s (K200119) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-04-01 |
| VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left (K193580) | Orthosensor, Inc. | 2020-04-01 |
| Venus VivaTM (K191065) | Venus Concept USA, Inc. | 2020-04-01 |
| SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GO (K200524) | Siemens Medical Solutions USA, Inc. | 2020-04-01 |
| DSI Dental Implant System (K200188) | Dsi Dental Solutions, Ltd. | 2020-04-01 |
| Focus 43C detector, TRIMAX 43C detector (K200622) | Iray Technology Taicang , Ltd. | 2020-04-01 |
| Manual Wheelchair (K192658) | Jerry Medical Instrument (Shanghai) Co., Ltd. | 2020-04-01 |
| Sectra Digital Pathology Module (K193054) | Sectra AB | 2020-03-31 |
| Tablo Hemodialysis System (K200741) | Outset Medical, Inc. | 2020-03-31 |
| Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential (K191860) | Semperit Technische Produkte Gesellchaft M.B.H. | 2020-03-31 |
| CytoCore (K200278) | Praxis Medical, LLC | 2020-03-31 |
| Trigger Switch and Cord (K200455) | New Deantronics Taiwan , Ltd. | 2020-03-31 |
| Rapid ICH (K193087) | Ischemaview Incorporated | 2020-03-31 |
| AquaFlate Pre-Filled Sterile Water Syringe 10mL (K200556) | H R Pharmaceuticals, Inc. | 2020-03-31 |
| SiteSeal Femoral Compression Device (K192413) | Ensite Vacular, LLC | 2020-03-31 |
| iCEWav Neuromonitoring Platform (K191868) | Ice Neurosystems, Inc. | 2020-03-31 |
| The Gecko Spinal System (K200281) | Ortho Development Corporation | 2020-03-31 |
| Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System (K192818) | Stryker Corporation | 2020-03-31 |