| Spinal Elements' Spinous Process Plate System (K160465) | Spinal Elements, Inc. | 2016-07-28 |
| Angel Catheter (K160747) | Bio2 Medical, Inc. | 2016-07-28 |
| Elecsys Syphilis (K160910) | Roche Diagnostics | 2016-07-28 |
| XSTAT-12, 3-Pack, XSTAT-12, 1-Pack (K161020) | Revmedx, Inc. | 2016-07-28 |
| Zeramex P6 Dental Implant System (K152385) | Dentalpoint AG | 2016-07-27 |
| SinuBand (K160101) | Bioinspire Technologies, Incorporated | 2016-07-27 |
| Tina-quant Cystatin C Gen.2 (K161817) | Roche Diagnostics Operations (Rdo) | 2016-07-27 |
| BEAUTIFIL II LS (K160596) | Shofu Dental Corporation | 2016-07-27 |
| The Progressive Orthopaedic Total Hip System (K151424) | The Progressive Orthopaedic Company, LLC | 2016-07-27 |
| Permaseal (DEN150029) | Micro Interventional Devices,Inc. | 2016-07-27 |
| Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress (K153067) | Sybron Dental Specialties | 2016-07-27 |
| Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap (K160755) | Ahlstrom Nonwovens, LLC | 2016-07-27 |
| HANAROCare ReJu (K160893) | M.I.Tech Co., Ltd. | 2016-07-27 |
| Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (K160367) | Nissin-Metec China Co., Ltd. | 2016-07-27 |
| Dillard Airway Dilatation System (K153484) | Intuit Medical Products, LLC | 2016-07-27 |
| Precision Screw (K160385) | Cryptych Pty, Ltd. | 2016-07-27 |
| Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 (K161198) | Usa Laser Biotech, Inc. | 2016-07-26 |
| Conventus Orthopaedics Ulna Fixation System (K161048) | Conventus Orthopaedics, Inc. | 2016-07-26 |
| DuraLazeTM HoLEP Laser Fiber (K153124) | Medkey, LLC | 2016-07-26 |
| Watch-PAT200U (K153070) | Itamar Medical , Ltd. | 2016-07-26 |
| ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) (K160757) | Axis-Shield Diagnostics Limited | 2016-07-26 |
| Atteris No-Sting Skin Protectant (K160684) | Rochal Industries, LLC | 2016-07-26 |
| Red2Green Reusable Sharps Container (K153363) | Triumvirate Environmental, Inc. | 2016-07-26 |
| Cook Intraosseous Infusion Needles (K160887) | Cook Incorporated | 2016-07-26 |
| truFreeze System (K161557) | CSA Medical, Inc. | 2016-07-26 |
| InPen (K160629) | Companion Medical, Inc. | 2016-07-26 |
| EasyStep (K160813) | Stryker GmbH | 2016-07-26 |
| VITRUVIAN ULTIMATE ASPIRATOR (K161722) | Black & Black Surgical, Inc. | 2016-07-26 |
| Hudson RCI AquaPak Sterile Prefilled Nebulizers (K153010) | Teleflexmedical, Inc. | 2016-07-26 |
| BostonSight PD Prosthetic Device (K161461) | Bostonsight | 2016-07-25 |
| Skyn Original Polyisoprene Lubricated Male Condom (K160399) | Ansell Healthcare Products, LLC | 2016-07-25 |
| cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System (K153544) | Iquum, Inc. | 2016-07-25 |
| Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating (K160411) | Cardinal Health, Inc. | 2016-07-25 |
| PacEndo Chlorhexidine (K160577) | Pac-Dent International, Inc. | 2016-07-25 |
| t:slim Insulin Delivery System (K160056) | Tandem Diabetes Care, Inc. | 2016-07-25 |
| NobelProcera HT ML FCZ Implant Bridge and Framework (K160158) | Nobel Biocare AB | 2016-07-25 |
| Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs (K161154) | Spr Therapeutics, LLC | 2016-07-23 |
| ReWalk(TM) (K160987) | Rewalk Robotics, Inc. | 2016-07-22 |
| Quantidex qPCR BCR-ABL IS Kit (DEN160003) | Asuragen, Inc. | 2016-07-22 |
| URITEK TC-201 URINE CHEMISTRY TEST SYSTEM (K160372) | Teco Diagnostics, Inc. | 2016-07-22 |
| Sheath Introducer (K150932) | Bioteque Corp. | 2016-07-22 |
| Gianturco-Roehm Bird’s Nest Vena Cava Filter (K161218) | Cook Incorporated | 2016-07-22 |
| Braemar Telemetry Patch System (K153473) | Braemar Manufacturing, LLC | 2016-07-22 |
| ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash (K153267) | Origio A/S | 2016-07-22 |
| ELAN 4 Motor System (K152960) | Aesculap, Inc. | 2016-07-22 |
| K2M Growing Spine System (K161028) | K2m, Inc. | 2016-07-22 |
| ST Internal Fixture System (K152787) | T-Plus Implant Tech. Co., Ltd. | 2016-07-22 |
| Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4 (K161009) | Toshibamedical Systems Corporation | 2016-07-22 |
| KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay (K161951) | Kronus, Inc. | 2016-07-22 |
| Vis-U-All Low Temperature Sterilization Pouch/Tubing (K160908) | STERIS Corporation | 2016-07-22 |
| LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set (K161139) | DiaSorin, Inc. | 2016-07-22 |
| Tritanium® PL Cage (K160955) | Stryker | 2016-07-21 |
| MectaLIF Anterior Stand-Alone (K160605) | Medacta International | 2016-07-21 |
| ET III Bio-SA Fixture System (K151626) | Hiossen, Inc. | 2016-07-21 |
| Dakin's Skin and Wound Cleanser (K150208) | Century Pharmaceuticals, Inc. | 2016-07-21 |
| EVEREST Spinal System (K161369) | K2m, Incorporated | 2016-07-21 |
| rainbow LS Block (K160144) | Genoss Co., Ltd. | 2016-07-21 |
| PathLoc-C Posterior Cervical Fixation System (K153439) | L&K BIOMED Co., Ltd. | 2016-07-21 |
| Genesys Spine Apache® Lateral Lumbar Interbody Fusion System (K161404) | Genesys Spine | 2016-07-21 |
| INTRAcel Premium Fractional RF Micro Needle (FRM) System (K153727) | Jeisys Medical, Inc. | 2016-07-21 |
| SHOFU Enamel Conditioner (K160086) | Shofu Dental Corporation | 2016-07-21 |
| BioHPP - breCAM.BioHPP (K152113) | Bredent GmbH & Co. KG | 2016-07-21 |
| SculpSure (K160470) | Cynosure, Inc. | 2016-07-21 |
| GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle (K152913) | Creganna Medical Aslo Business AS Cregganna Tactx Medical | 2016-07-21 |
| XP1100 RF (K152731) | BTL Industries, Inc. | 2016-07-20 |
| VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) (K161227) | bioMerieux, Inc. | 2016-07-20 |
| EVOTECH ECR (K152189) | Advanced Sterilization Products (Asp) | 2016-07-20 |
| NR Line Implant System (K153268) | Dentium Co., Ltd. | 2016-07-20 |
| MultiScan G-Arm System (K160984) | Beijing East Whale Imaging Technology Co., Ltd. | 2016-07-20 |
| OsteoFab Patient Specific Facial Device (K161052) | Oxford Performance Materials, Inc. | 2016-07-20 |
| PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System (K152599) | Ok Biotech Co., Ltd. | 2016-07-20 |
| SUNCO Mechanical Wheelchair, model SKW-9003 (K153328) | Danyang Sunco Machinery Co., Ltd. | 2016-07-20 |
| Operio (K153498) | Toul Meditech AB | 2016-07-20 |
| Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider (K160333) | Surgical Instrument Service and Savings, Inc. | 2016-07-20 |
| St. Louis Band (K161138) | Orthomerica Products, Inc. | 2016-07-20 |
| Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload (K161137) | Cardica, Inc. | 2016-07-20 |
| ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer (K152905) | Arc Devices Limited | 2016-07-20 |
| ABPM 7100, Hypertension Management Software (K153557) | I.E.M. GmbH | 2016-07-19 |
| Origin Coxa Vara Hip Stem (K161155) | Signature Orthopaedics Pty, Ltd. | 2016-07-19 |
| Ekso™ (version 1.1) and Ekso GT™ (version 1.2) (K161443) | Ekso Bionics, Inc. | 2016-07-19 |
| EnCor MRI Introducer Set, EnCor Probe Introducer (K161805) | Senorx, Inc. | 2016-07-19 |
| 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System (K161359) | Esaote, S.p.A. | 2016-07-19 |
| DePuy Actis DuoFix Hip Prosthesis (K160907) | Depuy(Ireland) | 2016-07-19 |
| INTRAFIX(TM) Advance Tibial Fastener System (K160804) | Medos International SARL | 2016-07-19 |
| RI Witness Embryology Heated Plate (K160504) | Research Instruments Limited | 2016-07-18 |
| Comfort Cover (K161920) | Precision Dynamics Corporation | 2016-07-15 |
| EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control (K151978) | Edan Instruments, Inc. | 2016-07-15 |
| myPatch-s (K160704) | Dms-Service, LLC | 2016-07-15 |
| TransContinental® M Spacers and InterContinental® Plate-Spacers (K161223) | Globus Medical, Inc. | 2016-07-15 |
| Threshold™ Pedicular Fixation System (K161694) | Spineology, Inc. | 2016-07-15 |
| NuVasive® VersaTie System (K161265) | Nu Vasive, Incorporated | 2016-07-15 |
| Ascential IBD PEEKc Spacer (K161407) | Stryker Spine | 2016-07-15 |
| Steth IO (K160016) | Stratoscientific, Inc. | 2016-07-15 |
| Keos Lumbar IBFD (K160631) | Keos | 2016-07-15 |
| FlexSeal Introducer Sheath with Hydrophilic Coating (K161659) | Libramedical, Inc. | 2016-07-15 |
| ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) (K161668) | Conformis, Inc. | 2016-07-15 |
| Juliet® Ti (K153621) | Spineart | 2016-07-15 |
| N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 (K160271) | San-M Package Co., Ltd. | 2016-07-15 |
| CAD/CAMouflage Milling Bock (K160425) | Prismatik Dentalcraft, Inc. | 2016-07-15 |
| Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) (K160308) | Fudakang Industrial Co., Ltd. | 2016-07-15 |