| EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories (K171307) | Endogastric Solutions, Inc. | 2017-06-22 |
| VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL) (K162737) | bioMerieux, Inc. | 2017-06-21 |
| Terrace™ Anterior Cervical Plate System (K163104) | Corelink, LLC | 2017-06-21 |
| VALIDATE D-Dimer Calibration Verification / Linearity Test Kit (K170864) | Maine Standards Company, LLC | 2017-06-21 |
| GOLNIT Non-Absorbable PTFE Surgical Suture (K163049) | Antarma Dba Golnit Sutures | 2017-06-21 |
| Biodesign Fistula Plug (K170016) | Cook Biotech Incorporated | 2017-06-21 |
| Retina Workplace (K170638) | Carl Zeiss Meditec, AG | 2017-06-21 |
| TVC Imaging System, TVC Catheter (K163345) | Infraredx, Inc. | 2017-06-21 |
| Venue (K170714) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2017-06-21 |
| BSD4343R Digital Flat Panel X-ray Detector (K171485) | Bontech, Inc. | 2017-06-21 |
| Embosphere Microspheres (DEN160040) | Biosphere Medical, S.A. | 2017-06-21 |
| DRX-Revolution Nano Mobile X-ray System (K170755) | Carestream Health, Inc. | 2017-06-21 |
| PRIMUS (K163195) | Carl Zeiss Suzhou Co., Ltd. | 2017-06-21 |
| ImPACT Quick Test (K170551) | Impact Applications, Inc. | 2017-06-21 |
| Solution Set with 1.2 Micron Air Eliminating Filter (K161808) | Baxter Healthcare Corporation | 2017-06-21 |
| Additive Orthopaedics Bunion System (K163593) | Additive Orthopaedics, LLC | 2017-06-20 |
| Compex Sport Elite (K170918) | Djo, LLC | 2017-06-20 |
| Summit Spine Channel Cervical Interbody Fusion System (K163494) | Summit Spine | 2017-06-20 |
| Corin MetaFix Hip Stem (K162942) | Corin U.S.A. Limited | 2017-06-20 |
| Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw (K170571) | Tyber Medical, LLC | 2017-06-20 |
| STERRAD VELOCITY Biological Indictator and Reader (K170039) | Advanced Sterilization Products (Asp) | 2017-06-20 |
| Stryker SonicPin System (K170418) | Stryker Trauma GmbH | 2017-06-20 |
| COSMED K5 Wearable Metabolic Technology (K162515) | Cosmed Srl | 2017-06-20 |
| Premium Plus Disposable Barrier Sleeve (K163447) | Premium Plus International Limited | 2017-06-20 |
| Materialise Glenoid Positioning System (K170893) | Materialise NV | 2017-06-19 |
| DEKA MOTUS AX (K162886) | El.En Electronic Engineering Spa | 2017-06-19 |
| Insulia Diabetes Management Companion (K170669) | Voluntis Sa. | 2017-06-19 |
| Compex Wireless USA (K170903) | Djo, LLC | 2017-06-19 |
| ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA (K162788) | Immco Diagnostics, Inc. | 2017-06-19 |
| Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System (K163506) | Vertera, Inc. | 2017-06-19 |
| Möller Medical Biopsy Needles and Systems (K162588) | Moller Medical GmbH | 2017-06-19 |
| Phantom Small Bone Intramedullary Nail System (K170693) | Paragon 28, Inc. | 2017-06-19 |
| Hydris™ Oral Rinse (K163029) | Biopharm Consult, LLC | 2017-06-19 |
| Smith & Nephew, Inc. R3™ Constrained Liner (K162641) | Smith & Nephew, Inc. | 2017-06-19 |
| Diode Laser Hair Removal System (K162659) | Shandong Huamei Technology Co., Ltd. | 2017-06-16 |
| Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae (K162215) | Sorin Group Italia S.R.L. | 2017-06-16 |
| A1C EZ Glycohemoglobin Analysis System (K161533) | Biohermes Co., Ltd. | 2017-06-16 |
| Cure™ Lumbar Plate System (K171538) | Meditech Spine, LLC | 2017-06-16 |
| DORA Tubing Sets for Hemodialysis (K161582) | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2017-06-16 |
| Silhouette InstaLift (K163676) | Silhouette Lift, Inc. | 2017-06-16 |
| MagVita TMS Therapy System (K171481) | Tonica Elektronik A/S | 2017-06-16 |
| Quantum TTC Biliary Balloon Dilator (K171223) | Wilson-Cook Medical, Inc. | 2017-06-16 |
| BioPro Foot Plating Systems (K162674) | Biopro, Inc. | 2017-06-16 |
| Green16/Green18 (Model: PHT-65LHS) (K170066) | VATECH Co., Ltd. | 2017-06-16 |
| Alians Fragment Specific (K170843) | Newclip Technics | 2017-06-16 |
| Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter (K170474) | Innovative Health, LLC | 2017-06-16 |
| Infinix INFX-8000V, V6.40 (K170909) | Toshiba Medical Systems Coroporation | 2017-06-16 |
| SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System (K170191) | Medtronic Vascular, Inc. | 2017-06-16 |
| AcuNav V 10F Ultrasound Catheter (K170992) | Siemens Medical Solutions USA, Inc. | 2017-06-15 |
| Encore Neutral (K162826) | Rymed Technologies, LLC | 2017-06-15 |
| SIMPLANT Guide (K170849) | Dentsply Sirona | 2017-06-15 |
| TroClose1200, TroClose1200 Cannula (K171494) | Gordian Surgical, Ltd. | 2017-06-15 |
| FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR (K162749) | Fujifilm Medical Systems U.S.A, Inc. | 2017-06-15 |
| Aptima Herpes Simplex Viruses 1 & 2 Assay (K162673) | Hologic, Inc. | 2017-06-15 |
| Merit Coronary Control Syringe (K163084) | Merit Medical Systems, Inc. | 2017-06-15 |
| Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White) (K170198) | Cardinal Health, Inc. | 2017-06-15 |
| SeaSpine Shoreline ACS - Anterior Cervical Standalone System (K170569) | SeaSpine Orthopedics Corporation | 2017-06-15 |
| sensiLift (K170499) | El Global Trade, Ltd. | 2017-06-15 |
| Katalyst Cyclophotocoagulation Probe (K163632) | Katalyst Surgical, LLC | 2017-06-15 |
| ATTUNE Cemented Tibial Base, Fixed Bearing (K170806) | Depuy(Ireland) | 2017-06-15 |
| Alma Q (K170850) | Alma Lasers , Ltd. | 2017-06-15 |
| AccuPoint Electrode (K162459) | Microprobes For Life Science, Inc. Dba Neuron | 2017-06-15 |
| Axiom PX (K161177) | Anthogyr Sas | 2017-06-15 |
| AcuNav Diagnostic Ultrasound Catheter 8F,10F (K170263) | Siemens Medical Solutions USA, Inc. | 2017-06-15 |
| HydroMARK Breast Biopsy Site Markers (K170803) | Devicor Medical Products, Inc. | 2017-06-15 |
| BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell (K170288) | Microport Orthopedics, Inc. | 2017-06-15 |
| EchoPAC Software Only, EchoPAC Plug-in (K170847) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2017-06-14 |
| iTotal® Hip Replacement System (K162719) | Conformis, Inc. | 2017-06-14 |
| UltraScore Focused Force PTA Balloon (K163420) | Bard Peripheral Vascular, Inc. | 2017-06-14 |
| MAGNETOM Vida (K170396) | Siemens Medical Solutions USA, Inc. | 2017-06-14 |
| Alzair Allergy Blocker (K170848) | Nasaleze International, Ltd. | 2017-06-14 |
| EVOS Small Fragment Lower Extremity Plates (K170457) | Smith & Nephew, Inc. | 2017-06-14 |
| BodyTom Elite (K170238) | Neurologica Corporation, A Subsidiary of Samsung Electronics | 2017-06-14 |
| TONOPORT VI (K170966) | Par Medizintechnik GmbH & Co. KG | 2017-06-14 |
| Follicle Aspiration Set (K161970) | Vitrolife Sweden AB | 2017-06-14 |
| Endoform Topical Matrix (K171231) | Aroa Biosurgery | 2017-06-14 |
| C-Line Orthodontic Ceramic Bracket (K163467) | Biocetec Co., Ltd. | 2017-06-14 |
| Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators (K161216) | Immunalysis Corporation | 2017-06-14 |
| Howell Biliary Introducer Needle (K160890) | Wilson-Cook Medical, Inc. | 2017-06-14 |
| hema-screen SPECIFIC Gold (K171484) | Immunostics Inc., | 2017-06-14 |
| Vivid S60N, Vivid S70N (K170878) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2017-06-14 |
| Sculpsure (K171111) | Cynosure, Inc. | 2017-06-13 |
| Deep Conical (DC) Implants and Accessories (K163060) | Southern Implants (Pty), Ltd. | 2017-06-13 |
| FUSE Spinal System (K171468) | Medtronic Sofamor Danek | 2017-06-13 |
| da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree (K171426) | Intuitive Surgical, Inc. | 2017-06-13 |
| HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System (K163079) | Healthlight, LLC | 2017-06-13 |
| COOK Vacuum Pump (K160753) | William A. Cook Australia Pty. , Ltd. | 2017-06-13 |
| SECRET RF (K170325) | Ilooda Co,., Ltd. | 2017-06-13 |
| Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette (K171427) | Medtronic Vascular, Inc. | 2017-06-13 |
| da Vinci Xi Surgical System (K170713) | Intuitive Surgical, Inc. | 2017-06-13 |
| SonoSite X-Porte Ultrasound System (K171437) | FUJIFILM Sonosite, Inc. | 2017-06-12 |
| Iliad® Pedicle Screw System and Zenius® Pedicle Screw System (K171509) | Medyssey USA, Inc. | 2017-06-12 |
| SPIRA Open Matrix ALIF (K162986) | Camber Spine Technologies | 2017-06-12 |
| 1417WCC_127um and1417WCC_140um (K171418) | Rayence Co., Ltd. | 2017-06-12 |
| Vivid E80, Vivid E90, Vivid E95 (K170823) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2017-06-12 |
| 1417WGC_127um and 1417WGC_140um (K171417) | Rayence Co., Ltd. | 2017-06-12 |
| SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters (K162625) | B. Braun Interventional Systems, Inc. | 2017-06-12 |
| MELODY, Remote Control System for Ultrasound Probe (K161354) | Adecho Tech | 2017-06-12 |
| Picocare (K162755) | Wontech Co., Ltd. | 2017-06-12 |
| 1717SGC_127um and 1717SGC_140um (K171419) | Rayence Co., Ltd. | 2017-06-09 |