| Silver High Performance Dressing (K183645) | Advanced Medical Solutions, Ltd. | 2019-05-29 |
| IGNITE Bone Void Filler (K190482) | Wrightmedicaltechnologyinc | 2019-05-28 |
| MectaLock PEEK Suture Anchor (K190474) | Medacta International S.A. | 2019-05-28 |
| Optilite IgM CSF Kit (K190686) | The Binding Site Group , Ltd. | 2019-05-28 |
| Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile (K190606) | Kossan International Sdn Bhd | 2019-05-28 |
| Clearlink System Solution Set (K180739) | Baxter Healthcare Corporation | 2019-05-28 |
| AccelFix Spinal Fixation System (K182544) | L&K BIOMED Co., Ltd. | 2019-05-28 |
| Nihon Kohden SVM-7200 Series Vital Signs Monitor (K190468) | Nihon Kohden Corporation | 2019-05-28 |
| Surgical Face Mask (K182515) | Wuhan Dymex Healthcare Co., Ltd. | 2019-05-27 |
| TruDiagnosis System (K183530) | Akonni Biosystems, Inc. | 2019-05-24 |
| Tria Firm Ureteral Stent (K190603) | Boston Scientific Corporation | 2019-05-24 |
| Soliton Acoustic Wave Device (K190542) | Soliton, Inc. | 2019-05-24 |
| Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter (K181979) | Teleflexmedical, Inc. | 2019-05-24 |
| Jaysun Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K182575) | Jiangxi Jaysun Medcare Co., Ltd. | 2019-05-24 |
| InCore® Lapidus Sterile Kits (K190231) | Nextremity Solutions, Inc. | 2019-05-24 |
| Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix (K190378) | Bioncise NV | 2019-05-24 |
| COMPLETE CONTROL System Gen2 (K191083) | Coapt, LLC | 2019-05-24 |
| MobileLink Acetabular Cup System (K182321) | Waldemar Link GmbH & Co. KG | 2019-05-24 |
| Envision ultrasound pad and cover (K190802) | Civco Medical Solutions | 2019-05-24 |
| Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) (K190282) | Spectrum Medical , Ltd. | 2019-05-24 |
| Conical Plus Implant System (K181157) | Osseofuse International, Inc. | 2019-05-24 |
| Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove (K190077) | Molnlycke Health Care Us, LLC | 2019-05-24 |
| LightLas Pattern Scanning System - TruScan Pro (K190448) | Light-Med(Usa), Inc. | 2019-05-24 |
| Mariner Outrigger Revision System (K183639) | SeaSpine Orthopedics Corporation | 2019-05-23 |
| Longterm NPWT Foam Dressing Kit (K182458) | Zhejiang Longterm Medical Technology Co., Ltd. | 2019-05-23 |
| Aptima BV Assay (K190452) | Hologic, Inc. | 2019-05-23 |
| Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit (K190441) | Cepheid | 2019-05-23 |
| Aptima Combo 2 Assay (Panther System) (K190515) | Hologic, Inc. | 2019-05-23 |
| Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit (DEN180032) | Cd Diagnostics, Inc. | 2019-05-23 |
| ERBEFLO 2 Disposable Tubing System (K190469) | Erbe USA, Inc. | 2019-05-23 |
| PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus (K183654) | Pentax of America, Inc. | 2019-05-23 |
| MaxCap Ped and MaxCap Neo (K182362) | Maxtec, LLC | 2019-05-23 |
| Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs (K190018) | Ansell Healthcare Products, LLC | 2019-05-23 |
| IMPEDE-FX Embolization Plug (K182390) | Shape Memory Medical | 2019-05-23 |
| Upstream GoBack Crossing Catheter (K182937) | Upstream Peripheral Technologies, Ltd. | 2019-05-23 |
| Luna 3D GEN2 Interbody Fusion System (K183560) | Benvenue Medical, Inc. | 2019-05-23 |
| ZIKV Detect 2.0 IgM Capture ELISA (DEN180069) | InBios International, Inc. | 2019-05-23 |
| SYNMESH System (K183054) | Depuy Synthes Spine | 2019-05-23 |
| KATANA Zirconia Block (K190436) | Kuraray Noritake Dental, Inc. | 2019-05-23 |
| Rampart One Lumbar Interbody Fusion System (K191091) | Spineology, Inc. | 2019-05-23 |
| Ambu aScope 4 RhinoLaryngo Slim (K191080) | Ambu A/S | 2019-05-22 |
| Bladder Scanner (Models: M2, M2-W, M1, M1-W) (K190769) | Suzhou Lischka Medtech Co., Ltd. | 2019-05-22 |
| Connector System (K190751) | Orthofix, Inc. | 2019-05-22 |
| LIAC S (K182374) | Sit Sordina Iort Technologies Spa | 2019-05-22 |
| Dental Ceramic (K182350) | Baot Biological Technology Co., Ltd. | 2019-05-22 |
| HERA I10 Diagnostic Ultrasound System (K190444) | Samsung Medison Co., Ltd. | 2019-05-22 |
| Erbe ESU Model VIO 3 with Accessories (K190823) | Erbe Elektromedizin GmbH | 2019-05-22 |
| RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope (K190902) | Wenzhou Renhua Instruments Co., Ltd. | 2019-05-22 |
| cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit (K190433) | Roche Molecular Systems, Inc. | 2019-05-22 |
| Soniquence RF Generator and Soniquence Electrodes (K183611) | Soniquence, LLC | 2019-05-22 |
| Stealth-Midas MR8 System (K183644) | Medtronic Powered Surgical Solutions | 2019-05-22 |
| ET IV SA Dental Implants (K183242) | Hiossen, Inc. | 2019-05-21 |
| Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure (K183646) | Edwards Lifeciences, LLC | 2019-05-21 |
| Solax Powered Wheelchair (K182576) | Dongguan Prestige Sporting Goods Co., Ltd. | 2019-05-21 |
| Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) (K182711) | Kelyniam Global, Inc. | 2019-05-21 |
| Smith & Nephew Tablet Application (K190367) | Smith & Nephew | 2019-05-21 |
| MAKO 7 (K182975) | Boston Scientific Corporation | 2019-05-21 |
| IntraLock Lapidus System (K182342) | Fusion Orthopedics, LLC | 2019-05-21 |
| Nerivio Migra (DEN180059) | Theranica Bioelectronics , Ltd. | 2019-05-20 |
| Full Automatic (NIBP) Blood Pressure Monitor-HL158TB (K190134) | Health & Life Co., Ltd. | 2019-05-20 |
| OnSite Waste Sharps Container (K182235) | Bluestone Medical, Inc. | 2019-05-20 |
| VersaCross Transseptal Sheath (K183655) | Baylis Medical Company, Inc. | 2019-05-20 |
| Aperio AT2 DX System (K190332) | Leica Biosystems Imaging, Inc. | 2019-05-20 |
| FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire (K190125) | T.A.G. Medical Products Corporation, Ltd. | 2019-05-19 |
| QIAstat-Dx Respiratory Panel (K183597) | QIAGEN GmbH | 2019-05-18 |
| iRestore Professional 282 (K183417) | Freedom Laser Therapy, Inc. | 2019-05-17 |
| Navigation Enabled Instruments (K183381) | Stryker | 2019-05-17 |
| Dimension EXL High-Sensitivity Troponin I (TNIH) Assay (K190675) | Siemens Healthcare Diagnostics, Inc. | 2019-05-17 |
| DRX-Revolution Mobile X-ray System (K191025) | Carestream Health, Inc. | 2019-05-17 |
| Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle (K183035) | Cook Incorporated | 2019-05-17 |
| Cook Unimpregnated Central Venous Catheter (K182252) | Cook Incorporated | 2019-05-17 |
| CardioGard Emboli Protection Cannula (K182302) | Cardiogard Medical, Ltd. | 2019-05-17 |
| Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurfac (K191029) | Medtronic, Inc. | 2019-05-17 |
| Delta Xtend Reverse Shoulder System (K183077) | Depuy(Ireland) | 2019-05-17 |
| Revolution Radial Head (K183618) | Ignite Orthopedics, Inc. | 2019-05-17 |
| KY Banksy Moisture (K183505) | Rb Health (Us), LLC | 2019-05-17 |
| Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip) (K191015) | Cook Incorporated | 2019-05-17 |
| WiZARD 310/320 Series CPAP Mask (K182394) | Apex Medical Corp. | 2019-05-17 |
| SD Abutment (K173570) | Surgident Co., Ltd. | 2019-05-17 |
| Dolphin/IQ, Dolphin/4D and Dolphin/MAX (K191023) | Viasonix , Ltd. | 2019-05-16 |
| Precision Casting Solutions Total Knee System (K190355) | Precision Casting Solutions, Inc. | 2019-05-16 |
| Aveta System (K190372) | Meditrina, Inc. | 2019-05-16 |
| Carnation Ambulatory Monitor (K191000) | Bardy Diagnostics, Inc. | 2019-05-16 |
| ARGOS (K191051) | Santec Corporation | 2019-05-16 |
| Aptima CV/TV Assay (K190472) | Hologic, Inc. | 2019-05-16 |
| EVOLUTION NitrX Medial-Pivot Knee (K182251) | Mircoport Orthopedics, Inc. | 2019-05-16 |
| VPC (K190345) | PAJUNK GmbH Medizintechnologie | 2019-05-16 |
| Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac (K182734) | Unicon Optical Co., Ltd. | 2019-05-16 |
| Tel-O-Graph (K173895) | I.E.M. Industrielle Entwicklung and Medizintechnik | 2019-05-16 |
| syngo.via (Version VB40A) (K191040) | Siemens Healthcare GmbH | 2019-05-16 |
| Fully Automatic Electronic Blood Pressure Monitor (K183534) | Andon Health Co, Ltd. | 2019-05-16 |
| REMY Medical Therapy Laser System (K190034) | Footdocprenur, LLC | 2019-05-15 |
| Masimo Rad-97 and Accessories (K183697) | Masimo Corporation | 2019-05-15 |
| SOFIA EX Intracranial Support Catheter (K182602) | MicroVention, Inc. | 2019-05-15 |
| CAYMAN LP Plate System (K190584) | K2m, Inc. | 2019-05-15 |
| SpO2 Sensor (K183277) | Shenzhen Upnmed Equipment Co., Ltd. | 2019-05-15 |
| Topaz Mobile DR System (K183292) | DRGEM Corporation | 2019-05-15 |
| Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645 (K182408) | Olympus Medical Systems Corp. | 2019-05-15 |
| APAS Independence with Urine Analysis Module (K183648) | Clever Culture Systems AG | 2019-05-15 |
| Endosee System (K190639) | CooperSurgical, Inc. | 2019-05-15 |