| eMurmur ID (K181988) | Csd Labs GmbH | 2019-04-17 |
| VersaCross Steerable Sheath, VersaCross Transseptal Dilator (K190688) | Baylis Medical Company, Inc. | 2019-04-17 |
| SEKURE Creatine Kinase Assay (K182702) | Sekisui Diagnostics P.E.I., Inc. | 2019-04-17 |
| Andorate Auxiliary Water Connector (K182998) | Smartdata Suzhou Co., Ltd. | 2019-04-17 |
| SmartLinx Vitals Plus Patient Monitoring System (K183638) | Capsule Technologie | 2019-04-17 |
| Ultra OTC Facial Toning System (K183189) | Micro Current Technology, Inc. | 2019-04-17 |
| Arthrex SwiveLock Anchors (K190728) | Arthrex, Inc. | 2019-04-17 |
| M-Y Sheath (K190369) | Ram Medical Innovations, Inc. | 2019-04-17 |
| Dr. Amplatz Micro Plug (K182944) | Ka Medical, LLC | 2019-04-17 |
| Stasis Monitoring System (K183634) | Stasis Labs, Inc. | 2019-04-17 |
| Avulsion Forceps (K183428) | STERIS Corporation | 2019-04-16 |
| Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use (K182217) | Ezisurg (Suzhou) Medical Co., Ltd. | 2019-04-16 |
| Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device (K183619) | Boston Scientific Corporation | 2019-04-16 |
| KY Banksy Aloe (K183302) | Rb Health (Us), LLC | 2019-04-16 |
| “BRAXX” Esophageal Brachytherapy Applicator (K183332) | Braxx Biotech Co., Ltd. | 2019-04-16 |
| MIST IC (K182246) | Imagine Milling Technologies, LLC | 2019-04-16 |
| General Cutting Contra Handpiece (K182999) | Nakanishi, Inc. | 2019-04-16 |
| Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK (K181541) | Andon Health Co, Ltd. | 2019-04-16 |
| Elecsys TSH (K190773) | Roche Diagnostics | 2019-04-16 |
| WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream (K190705) | Wholepower Biotech Co., Ltd. | 2019-04-15 |
| Diode Laser Treatment System (K182924) | Weifang KM Electronics Co., Ltd. | 2019-04-15 |
| Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis (K182272) | Sterilmed, Inc. | 2019-04-15 |
| Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer (K182828) | Surgical Instrument Service and Savings, Inc. | 2019-04-15 |
| One Touch (K181844) | Thai Nippon Rubber Industry Public Company, Ltd. | 2019-04-15 |
| Rigi10 Malleable Penile Prosthesis (K181673) | Rigicon, Inc. | 2019-04-15 |
| BriefCase (K190072) | Aidoc Medical , Ltd. | 2019-04-15 |
| SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16 (K183548) | Siemens Medical Solutions USA, Inc. | 2019-04-15 |
| NDOHD High Definition Imaging System (NDOHD) (K190420) | Altaravision, Inc. | 2019-04-15 |
| PreXion3D Explorer (K190320) | Prexion Corporation | 2019-04-15 |
| INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir (K190690) | Sorin Group Italia S.R.L. | 2019-04-13 |
| ArgenZ HT+ (K190079) | The Argen Corporation | 2019-04-12 |
| Ascent Cardiorespiratory Diagnostic Software (K181912) | Medical Graphics Corporation | 2019-04-12 |
| D-Clip; D-Clip Applier (K180757) | Peter Lazic GmbH | 2019-04-12 |
| ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel (K182619) | Genmark Diagnostics, Incorporated | 2019-04-12 |
| TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants (K182891) | Cs Medical, LLC | 2019-04-12 |
| KardiaMobile, KardiaStation (K182396) | AliveCor, Inc. | 2019-04-12 |
| PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit (K181915) | Ixensor Co, Ltd. | 2019-04-12 |
| Baby Gorilla/Gorilla Plating System (K190365) | Paragon 28, Inc. | 2019-04-12 |
| RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review (K190664) | Brainlab AG | 2019-04-12 |
| Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface (K183490) | Medtronic, Inc. | 2019-04-12 |
| 3T 32 Channel Head Coil (K182737) | Nova Medical, Inc. | 2019-04-12 |
| MIS Bunion Plating System (K190658) | Crossroads Extremity Systems, LLC | 2019-04-12 |
| Plenity (DEN180060) | Gelesis, Inc. | 2019-04-12 |
| Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter (K183599) | Infraredx, Inc. | 2019-04-12 |
| PuraSinus (K183015) | 3-D Matrix, Inc. | 2019-04-12 |
| Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue) (K182640) | Shandong Hengya Packaging Printing Co.,Ltd | 2019-04-12 |
| InstaRISPACS / InstaZFP / InstaMobi v5.0 (K182572) | Meddiff Technologies Pvt. , Ltd. | 2019-04-12 |
| Deep Learning Image Reconstruction (K183202) | Ge Medical Systems, LLC | 2019-04-12 |
| SyncVision System (K190626) | Volcano Corporation | 2019-04-12 |
| PureSleep (OTC use) (K190058) | Sleep Science Partners, Inc. | 2019-04-11 |
| Codman Electrosurgical Generator, Foot Pedal (K183526) | Kls Martin GmbH + Co. KG | 2019-04-11 |
| Syntec Femoral Nail System (K181296) | Syntec Scientific Corporation | 2019-04-11 |
| Zavation Spinal System (K190317) | Zavation Medical Products, LLC | 2019-04-11 |
| Endoform Restella (K183398) | Aroa Biosurgery , Ltd. | 2019-04-11 |
| Brux Night Guard (K181361) | Brux Night Guard | 2019-04-11 |
| Eye Prime (K190786) | Ellex Medical Pty, Ltd. | 2019-04-11 |
| VisCalor bulk (K190453) | Voco GmbH | 2019-04-11 |
| Sonopet iQ Ultrasonic Aspirator System (K190070) | Stryker Corporation | 2019-04-11 |
| ELRA Electrode (K181758) | Starmed Co., Ltd. | 2019-04-11 |
| S-MAK XL (K190175) | Merit Medical Systems, Inc. | 2019-04-10 |
| NAV PAK Needle, NIM NAV PAK Needle (K182662) | Boston Endo Surgical Tech, | 2019-04-10 |
| PUMA-G System (K183057) | Coaptech, LLC | 2019-04-10 |
| GLUCOCARD® W onyx Blood Glucose Monitoring System (K183306) | Arkray Factory, Inc. | 2019-04-10 |
| M.U.S.T. MINI Posterior Cervical Screws System (K190631) | Medacta International S.A. | 2019-04-10 |
| PROPHYflex 4 (K181110) | Kaltenbach & Voigt GmbH | 2019-04-10 |
| Oryum and Ovem Epidermal Deri Prick Test Applicator (K182582) | Allergy & Applicator Depot, LLC | 2019-04-10 |
| Confirm Rx Insertable Cardiac Monitor (K190295) | Abbott (St. Jude Medical) | 2019-04-10 |
| DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System (K183660) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-04-09 |
| Adult Intraosseous Infusion Device (K182770) | Einstein Works, LLC | 2019-04-09 |
| Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device (K181832) | Guangdong Transtek Medical Electronics Co., Ltd. | 2019-04-09 |
| ENConnect 40 mm Screw Cap to ENPlus Adapter (K190327) | Cedic S.R.L. | 2019-04-09 |
| ExcelsiusGPS (K190653) | Globus Medical, Inc. | 2019-04-09 |
| Vera (K182333) | Reflexion Health, Inc. | 2019-04-09 |
| Pantheris SV (K182341) | Avinger, Inc. | 2019-04-09 |
| CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS® (K182375) | Globus Medical, Inc. | 2019-04-08 |
| OIC External Fixation System (K183682) | Orthopaedic Implant Company | 2019-04-08 |
| Bone VCAR (BVCAR) (K183204) | GE Medical Systems SCS | 2019-04-08 |
| Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) (K183606) | Scandidos AB | 2019-04-08 |
| VIVIX-S 1751S (K190611) | Vieworks Co., Ltd. | 2019-04-08 |
| Straumann BLX Line Extension - New Abutments (K190040) | Institut Straumann AG | 2019-04-08 |
| Vitality® Spinal Fixation System (K183550) | Zimmer Biomet Spine, Inc. | 2019-04-08 |
| Ergoline Sunrise 7200 Hybrid Technology (K183539) | Jk-Holding GmbH | 2019-04-08 |
| JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor (K183496) | Nanjing Jusha Display Technology Co., Ltd. | 2019-04-08 |
| MEDINAUT Plus (K182287) | Imedicom Co., Ltd. | 2019-04-06 |
| OJR215 Pressure Relief Manifold (K173770) | Fisher & Paykel Healthcare Limited | 2019-04-05 |
| TCD-X (K182175) | Atys | 2019-04-05 |
| Patient Monitor (K181919) | Guangdong Biolight Meditech Co., Ltd. | 2019-04-05 |
| Xbody Newave USA (K190038) | Xbody Hungary Kft. | 2019-04-05 |
| CROSSWAY Spinal Access System (K190598) | Globus Medical, Inc. | 2019-04-05 |
| R190/R191 LCD Monitor (K183494) | Nanjing Jusha Display Technology Co., Ltd. | 2019-04-05 |
| Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K183287) | Kossan International Sdn Bhd | 2019-04-05 |
| Amplatzer Trevisio Intravascular Delivery System (K190581) | ABBOTT MEDICAL | 2019-04-05 |
| V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System (K190103) | STERIS Corporation | 2019-04-05 |
| EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit) (K182268) | Flat Medical Co., Ltd. | 2019-04-05 |
| EkoSonic Endovascular Device with Control Unit 4.0 (K183361) | Btg International, Inc. | 2019-04-05 |
| HIgH-Flo Super26 Subcutaneous Needle Sets (K180843) | Repro-Med Systems, Inc. Dba Rms Medical Products | 2019-04-04 |
| VERTEX Nitinol Staple System (K182943) | Nvision Biomedical Technologies, LLC | 2019-04-04 |
| Park Blade Septostomy Catheter (K182399) | Cook Incorporated | 2019-04-04 |
| Prettau, ICE, Z-White zirconia blanks (K183304) | Zirkonzahn Srl | 2019-04-04 |
| ToxCO (K173238) | Bedfont Scientific, Ltd. | 2019-04-04 |