| Arzzt Distal Radius and Ulna System (K182650) | Truemed Group, LLC | 2019-06-10 |
| Insight Essentials DRF Digital Imaging System (K191310) | Imaging Engineering, LLC | 2019-06-10 |
| AccuFill Bone Substitute Material (K190814) | Zimmer Knee Creations | 2019-06-10 |
| Mini Cannulated Headed and Headless Screw Set (K183104) | Stryker GmbH | 2019-06-10 |
| Vista FS, Vista FS Liquid (K190220) | Inter-Med/Vista Dental Products | 2019-06-10 |
| 7410 Ultrasound System (MyLabSigma) (K191072) | Esaote, S.p.A. | 2019-06-10 |
| SPINEART Navigation Instrument System (K183630) | Spineart SA | 2019-06-10 |
| SpaceFlex Knee (K190216) | G21, S.R.L. | 2019-06-09 |
| tün® ultrasonic tips product family (K182145) | Engineered Endodontics | 2019-06-07 |
| RIVAL View Plating Systems and Reduce Fracture Plating Systems (K190388) | Orthofix Srl | 2019-06-07 |
| TD Clip (K190051) | Zephyr Sleep Technologies, Inc. | 2019-06-07 |
| Ivenix Infusion System (IIS) (K183311) | Ivenix, Inc. | 2019-06-07 |
| CeraSeal (K190503) | Meta Biomed Co., Ltd. | 2019-06-07 |
| Miha Bodytec II (K182519) | Miha Bodytec GmbH | 2019-06-07 |
| Ceramic Bracket (K180952) | Mem Dental Technology Co., Ltd. | 2019-06-07 |
| Andorate Auxiliary Water Connector, Andorate Valves Set (K191231) | Smartdata Suzhou Co., Ltd. | 2019-06-07 |
| Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable (K183649) | Baylis Medical Company, Inc. | 2019-06-07 |
| VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 (K190916) | Vitalconnect, Inc. | 2019-06-07 |
| VITROS XT Chemistry Products ALB-TP Slides (K191316) | Ortho-Clinical Diagnostics, Inc. | 2019-06-07 |
| Masimo O3 Regional Oximeter System (K182429) | Masimo Corporation | 2019-06-07 |
| Hailie Sensor (K182573) | Adherium (Nz), Ltd. | 2019-06-07 |
| IB-Stim (DEN180057) | Innovative Health Solutions (Ihs), Inc. | 2019-06-07 |
| Argen Clear Aligner (K183229) | Argen Corporation | 2019-06-07 |
| DJO Acetabular System (K190057) | Encore Medical L.P. | 2019-06-07 |
| Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable (K183632) | Baylis Medical Company, Inc. | 2019-06-07 |
| da Vinci Handheld Camera (K191043) | Intuitive Surgical, Inc. | 2019-06-06 |
| PROSTEP TBC Implant System (K183620) | Wrightmedicaltechnologyinc | 2019-06-06 |
| RIGEL PEEK Anterior Cervical Interbody Fusion System (K190618) | MiRus, LLC | 2019-06-06 |
| Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid (K190827) | Uvision360, Inc. | 2019-06-06 |
| ComPAS2 (Computerized Pulmonary Analysis System) (K190568) | Morgan Scientific, Inc. | 2019-06-06 |
| Pure Vu System (K191220) | Motus GI Medical Technologies , Ltd. | 2019-06-06 |
| VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL) (K190616) | bioMerieux, Inc. | 2019-06-06 |
| Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags (K191335) | Corinth Medtech, Inc. | 2019-06-06 |
| Idys ALIF TiVac (K191263) | Clariance, Sas | 2019-06-06 |
| MINE (K180671) | Rht Co., Ltd. | 2019-06-05 |
| Low Dose Lung Screening Option (K190505) | Canon Medical Systems Corporation | 2019-06-05 |
| Corin BiPolar-i (K183114) | Corin U.S.A. Limited | 2019-06-05 |
| Biocode Gastrointestinal Pathogen Panel (GPP) (K190585) | Applied BioCode, Inc. | 2019-06-05 |
| Palm Bladder Scanner - PBSV5.1 (K191307) | Mianyang Meike Electronic Equipment Co., Ltd. | 2019-06-05 |
| Signature ONE System (K190595) | Orthosoft Inc (D/B/A Zimmer Cas) | 2019-06-05 |
| WatchPAT ONE (K183559) | Itamar Medical , Ltd. | 2019-06-05 |
| Materialise Mimics Enlight (K190874) | Materialise NV | 2019-06-05 |
| WalterLorenz Surgical Assist Arm Scope Holder (K190576) | Biomet Microfixation | 2019-06-05 |
| HydroCision TenJet Device (K190804) | Hydrocision, Inc. | 2019-06-05 |
| MectaScrew PEEK Interference Screw (K190892) | Medacta International S.A. | 2019-06-04 |
| Vanguard XP Knee System (K190068) | Zimmer, Inc. | 2019-06-04 |
| PDS Barbed Suture, PDO MAXX Threads (K190245) | Pdo Max, Inc. | 2019-06-04 |
| Unity Total Knee System (K183533) | Corin U.S.A. Limited | 2019-06-04 |
| Achieva 1.5T, 3.0T and Intera 1.5T MR Systems (K190461) | Philips Medical Systems Nederland B.V. | 2019-06-04 |
| CORTRAK* 2 Equilateral Enteral Access System (K191340) | Avanos Medical, Inc. | 2019-06-04 |
| Fully Automatic Electronic Blood Pressure Monitor (K183535) | Andon Health Co, Ltd. | 2019-06-04 |
| KOWA DR-1a (K190573) | Kowa Company , Ltd. | 2019-06-04 |
| TD-4183 Blood Glucose Monitoring System (K190579) | Taidoc Technology Corporation | 2019-06-04 |
| Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors (K182503) | Physio-Control, Inc. | 2019-06-03 |
| ReWalk Restore (K190337) | Re Walk Robotics , Ltd. | 2019-06-03 |
| Solanas® Posterior OCT Fixation System (K191185) | Alphatec Spine | 2019-06-03 |
| Diapex Plus (K182625) | DiaDent Group International | 2019-06-03 |
| Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB (K190564) | Bionime Corporation | 2019-06-02 |
| Erchonia FX-635 (K190572) | Erchonia Corporation | 2019-06-01 |
| Tiger Sharps Containers (K190240) | International Marketing Specialists, Inc. | 2019-05-31 |
| U Deliver Bolink ENFit Enteral Feeding Sets (K190310) | U Deliver Medical, LLC | 2019-05-31 |
| Cannulated Hemi Implant (K190543) | Vilex IN Tennessee, Inc. | 2019-05-31 |
| BriefCase (K190896) | Aidoc Medical , Ltd. | 2019-05-31 |
| NeuroShield (K190246) | Monarch Bioimplants GmbH | 2019-05-31 |
| E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor (K190831) | Nanjing Jusha Display Technology Co., Ltd. | 2019-05-31 |
| NEXXT MATRIXX Stand Alone Cervical System (K190546) | Nexxt Spine, LLC | 2019-05-31 |
| PALACOS fast R+G (K190766) | Heraeus Medical GmbH | 2019-05-31 |
| C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge (K190194) | Pentax Medical, A Division of Pentax of America, Inc. | 2019-05-31 |
| Cervical Plate (K190565) | Eisertech, LLC | 2019-05-31 |
| Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling (K182678) | Zimmer, Inc. | 2019-05-31 |
| Pristine Hemodialysis Catheter (K182443) | Pristine Access Technologies , Ltd. | 2019-05-31 |
| MAGNETOM Avanto Fit (K190757) | Siemens Medical Solution USA, Inc. | 2019-05-31 |
| Apis (K182725) | Sweetbio, Inc. | 2019-05-31 |
| Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs (K182308) | Sri Trang Gloves (Thailand) Co., Ltd. | 2019-05-30 |
| neXus Ultrasonic Surgical Aspirator System (K190160) | Misonix, Inc. | 2019-05-30 |
| Air Relax (K173158) | Maxstar Industrial Co., Ltd. | 2019-05-30 |
| ASHK100G (K191188) | Lg Electronics | 2019-05-30 |
| PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System (K183205) | Emcyte Corporation | 2019-05-30 |
| GaltTWS (K182660) | Galt Medical Corp. | 2019-05-30 |
| Arc Endocuff Glide AEG110 & AEG120 (K191067) | Boddingtons Plastics, Ltd. | 2019-05-30 |
| Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device (K190623) | Medtronic | 2019-05-30 |
| Qangio XA 3D (K182611) | Medis Medical Imaging Systems BV | 2019-05-30 |
| MasterLoc Extension (K191145) | Medacta International S.A. | 2019-05-30 |
| FlexSeal Introducer Sheath with Hydrophilic Coating (K190628) | Freudenberg Medical Mis, Inc. | 2019-05-30 |
| Swiss LithoClast Trilogy (K191124) | E.M.S Electro Medical Systems S.A | 2019-05-29 |
| Peel-Away Introducer (K182403) | Cook Incorporated | 2019-05-29 |
| uMR 780, uMR 790 (K191157) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-05-29 |
| Brain Perfusion (BP) application (K182716) | Philips Medical Systems Nederland B.V. | 2019-05-29 |
| Manual Wheelchair SIVFH2A102 (K190534) | Jiangsu Horizon Medical Science & Technology Co., Ltd. | 2019-05-29 |
| Entuit PEG, Entuit PEGJ (K183336) | Wilson-Cook Medical, Inc. | 2019-05-29 |
| Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) (K182526) | Vcomin Technology Limited | 2019-05-29 |
| MitraClip G4 Steerable Guide Catheter (K190167) | Abbott | 2019-05-29 |
| GuttaSil (K190510) | Meta Biomed Co., Ltd. | 2019-05-29 |
| Segmented Esophageal Stent System (K182910) | Micro-Tech (Nanjing) Co., Ltd. | 2019-05-29 |
| Fuji Cervical Plate System (K183084) | Altus Partners, LLC | 2019-05-29 |
| LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2 (K183337) | DMG Chemisch-Pharmazeutische Fabrik GmbH | 2019-05-29 |
| Revolution External Plating System (K181630) | New Standard Device Dba Metalogix | 2019-05-29 |
| MTS Doxycycline 0.016 - 256 µg/mL (K190914) | Liofilchem s.r.l. | 2019-05-29 |
| Juliet® Ti LL Lumbar Interbody Device (K190877) | Spineart | 2019-05-29 |
| 3M RelyX Pediatric Resin Modified Glass Ionomer Cement (K191122) | 3M Espe Dental Products | 2019-05-29 |