| Koya Ripple (K193288) | Koya, Inc. | 2020-06-16 |
| Pump In Style (K200508) | Medela, LLC | 2020-06-15 |
| CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ) (K201313) | Aziyo Biologics, Inc. | 2020-06-15 |
| F3D Cervical Stand-Alone Interbody Fusion System (K200087) | Corelink, LLC | 2020-06-15 |
| EndeavorRx (DEN200026) | Akili Interactive Labs, Inc. | 2020-06-15 |
| Visalis V500, Visalis S500 (K193376) | Carl Zeiss Meditec, AG | 2020-06-15 |
| Abiomed 23 Fr Sheath (K201116) | Abiomed, Inc. | 2020-06-15 |
| Centurion POCT System (K201481) | Orthofix, Inc. | 2020-06-15 |
| Quantib AI Node (K200899) | Quantib B.V. | 2020-06-15 |
| STERIS Patient Warming System (K200446) | STERIS Corporation | 2020-06-13 |
| Kubtec Mozart Supra (K200756) | Kub Technologies, Inc. | 2020-06-12 |
| Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe (K193379) | Edwards Lifesciences, LLC | 2020-06-12 |
| Full Automatic(NIBP) Blood Pressure Monitor (K200521) | Health & Life Co., Ltd. | 2020-06-12 |
| MAMMOMAT Revelation (K193166) | Siemens Medical Solutions USA, Inc. | 2020-06-12 |
| REAL INTELLIGENCE CORI (CORI) (K201022) | Blue Belt Technologies, Inc. | 2020-06-12 |
| ExpanSure Large Access Transseptal Dilator (K201288) | Baylis Medical Company, Inc. | 2020-06-12 |
| Electrical Stimulator System (K192201) | Gymmax Technology Shenzen Co., Ltd. | 2020-06-12 |
| Hemo Control (optional Add Pack Hemo Control DM) (K200909) | Ekf-Diagnostic GmbH | 2020-06-12 |
| FreeStyle Libre 2 Flash Glucose Monitoring System (K193371) | Abbott Diabetes Care, Inc. | 2020-06-12 |
| INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir (K200683) | Sorin Group Italia S.R.L. | 2020-06-12 |
| physIQ Heart Rhythm and Respiration Module (K193415) | Physiq, Inc. | 2020-06-11 |
| Versana Active (K200998) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-06-11 |
| RIGEL 3DR Anterior Cervical Interbody Fusion System (K200685) | MiRus, LLC | 2020-06-11 |
| MEDO ARIA (K200356) | Medo.Ai | 2020-06-11 |
| Gold Anchor (K201117) | Naslund Medical AB | 2020-06-11 |
| E>EyeC (K200616) | E-Swin | 2020-06-11 |
| In-Ka Ureteral Balloon Dilatation Catheter (K201007) | Coloplast Corp. | 2020-06-11 |
| uWS-MI (K192630) | Shanghai United Imaging Healthcare Co., Ltd. | 2020-06-11 |
| Benchmark BMX96 Access System (K201271) | Penumbra, Inc. | 2020-06-11 |
| Auto 3D Bladder Volume Tool (K200980) | Butterfly Network, Inc. | 2020-06-11 |
| BruxZir Steel (K200131) | Prismatik Dentalcraft, Inc. | 2020-06-10 |
| Hemospray Endoscopic Hemostat (K200972) | Wilson-Cook Medical, Inc. | 2020-06-10 |
| TSolution® One Total Knee Application (K201255) | THINK Surgical, Inc. | 2020-06-10 |
| Auxein Nailing System (K192003) | Auxein Medical Private Limited | 2020-06-10 |
| SR-8230, SR-8230S Portable X-ray Unit (K200976) | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2020-06-10 |
| Naviswiss Hip Navigation System (K193094) | Naviswiss AG | 2020-06-10 |
| RayCare 3.1 (K200487) | RaySearch Laboratories AB (PUBL) | 2020-06-10 |
| SeaSpine Meridian System, SeaSpine Regatta Lateral System (K200879) | SeaSpine Orthopedics Corporation | 2020-06-10 |
| Intraoral Sensor (K201247) | Dentium Co., Ltd (Ict Branch) | 2020-06-10 |
| ImmersiveView Surgical Plan (IVSP®) (K181813) | Immersivetouch | 2020-06-09 |
| Venus Epileve (K200786) | Venus Concept USA, Inc. | 2020-06-09 |
| IBS Implant System II (K200753) | Innobiosurg Co., Ltd. | 2020-06-09 |
| DANNIK Disposable Monopolar Laparoscopic Instrument (K201063) | Dannik | 2020-06-09 |
| CO2 Laser System (K200042) | Beijing Superlaser Technology Co., Ltd. | 2020-06-09 |
| Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip (K192033) | Bennett Jacoby, Dds, Ms, Inc. | 2020-06-09 |
| Osteo3 ZP Putty (K193075) | Sirakoss , Ltd. | 2020-06-09 |
| ePM Series Patient monitors (K200015) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-06-08 |
| Air Compression Therapy Device (K193354) | Shenzhen Dongjilian Electronics Co., Ltd. | 2020-06-08 |
| The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System (K193067) | Wrightmedicaltechnologyinc | 2020-06-08 |
| mCare(R) Powder Free Nitrile Orange Examination Gloves (K200967) | Mercator Medical (Thailand), Ltd. | 2020-06-06 |
| Exofin Fusion Skin Closure System (K191461) | Chemence Medical, Inc. | 2020-06-05 |
| Voyant Open Fusion Device (K201212) | Applied Medical Resources Corp. | 2020-06-05 |
| NemoCast (K193003) | Software Nemotec S.L. | 2020-06-05 |
| 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H (K192550) | 3M Company | 2020-06-05 |
| UroLift Advanced Tissue Control (ATC) System (K200441) | Neotract, Inc. | 2020-06-05 |
| epoc Blood Analysis System (K200107) | Epocal, Inc. | 2020-06-05 |
| AxSOS 3 AF System and AxSOS 3 Ti System (K200398) | Stryker GmbH | 2020-06-05 |
| Hummingbird Tympanostomy Tube System (K200952) | Preceptis Medical, Inc. | 2020-06-05 |
| Signature ONE System (K200615) | Orthosoft Inc (D/B/A Zimmer Cas) | 2020-06-05 |
| VivaChek Blood Glucose and B-Ketone Monitoring System (K192957) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2020-06-05 |
| Latex Examination Powder Free Glove, Aloe Vera (K193150) | Top Glove Sdn. Bhd. | 2020-06-05 |
| EZ-Cover (K191491) | Medxpress.Pro | 2020-06-05 |
| Spire Health Remote Patient Monitoring System (K192952) | Spire, Inc. D/B/A Spire Health | 2020-06-05 |
| CarboClear® Cervical Plate System (K200883) | CarboFix Orthopedics , Ltd. | 2020-06-04 |
| bioli lOL Delivery System (K200057) | Ast Products, Inc. | 2020-06-04 |
| LZI Tramadol Enzyme Immunoassay (K201223) | Lin-Zhi International, Inc. | 2020-06-04 |
| Livongo Blood Glucose Monitoring System (BG1000) (K200277) | Livongo Health, Inc. | 2020-06-04 |
| HEALIX ADVANCE Anchor with DYNATAPE Suture (K200949) | Medos International SARL | 2020-06-04 |
| Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate (K193555) | Ever Global (Vietnam) Enterprise Corp | 2020-06-04 |
| Oxylight (K200104) | Raja Trading Company, Inc. | 2020-06-04 |
| Journey II XR Knee Instrument (K200227) | Smith & Nephew, Inc. | 2020-06-04 |
| t:slim X2 Insulin Pump with Interoperable Technology (K201214) | Tandem Diabetes Care, Inc. | 2020-06-04 |
| Halo™ Single-Loop Snare Kit (K200268) | Argon Medical Devices, Inc. | 2020-06-03 |
| Flap Fixator, Burr Hole Cover (K192310) | Ossaware Biotech Co., Ltd. | 2020-06-03 |
| QLAB Advanced Quantification Software (K200974) | Philips Health Care | 2020-06-03 |
| AltiVate Anatomic Canal-Sparing (CS) Shoulder (K193226) | Encore Medical L.P. | 2020-06-03 |
| Agilis HisPro Steerable Catheter With Electrodes (K200721) | Abbott (St. Jude Medical) | 2020-06-03 |
| Cardioblate Gemini-s Surgical Ablation Device (K200514) | Medtronic | 2020-06-03 |
| pREBOA-PRO Catheter (K200459) | Prytime Medical Devices, Inc. | 2020-06-03 |
| Hair Growth System (K200929) | Xuzhou Kernel Medical Equipment Co., Ltd. | 2020-06-03 |
| Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant (K200602) | CC Wellness, LLC | 2020-06-03 |
| DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader (K200506) | Chembio Diagnostic Systems | 2020-06-03 |
| StealthStation Cranial Software v1.3.0 (K201175) | Medtronic Navigation, Inc. | 2020-06-03 |
| Vantage Orian 1.5T, MRT-1550, V6.0 (K193021) | Canon Medical Systems Corporation | 2020-06-03 |
| Thales 3D Mr Scanner (K200907) | Lap GmbH Laser Applikationen | 2020-06-03 |
| StarPore (K200532) | Anatomics Pty, Ltd. | 2020-06-02 |
| Bunny Wax Personal Lubricant (K192779) | Reoxcyn, LLC | 2020-06-02 |
| 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil (K201101) | Neocoil, LLC | 2020-06-02 |
| iMac 27 & PL 4.0 (K200889) | Quantum-Spectra, LLC | 2020-06-02 |
| MIRA Adapter (K200911) | Phakos | 2020-06-02 |
| HIP7 (K193307) | Brainlab AG | 2020-06-02 |
| Altus Spine Pedicle Screw System (K200322) | Altus Partners, LLC | 2020-06-02 |
| MI View&GO (K201202) | Siemens Medical Solutions USA, Inc. | 2020-06-02 |
| gastroduodenal FTRD Set (K200684) | Ovesco Endoscopy AG | 2020-06-02 |
| Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism (K200528) | Bausch + Lomb, Incorporated | 2020-06-02 |
| F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model (K200089) | Fisher & Paykel Healthcare, Ltd. | 2020-06-02 |
| DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) (K193438) | Pro Med Instruments GmbH | 2020-06-02 |
| Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) (K200897) | Hartalega Sdn Bhd | 2020-06-01 |
| Skeletal Dynamics Forearm Plating System (K200538) | Skeletal Dynamics, Inc. | 2020-06-01 |
| Vitls Platform (K191620) | Vitls, Inc. | 2020-06-01 |