| Oragene Dx (K152556) | DNA Genotek, Inc. | 2016-05-26 |
| G7 Dual Mobility System, Active Articulation System (K161190) | Biomet, Inc. | 2016-05-26 |
| ArcadiusXP C Spinal System (K153629) | Aesculap Implant Systems, Inc. | 2016-05-25 |
| Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement (K153026) | Medtec, Inc. D/B/A Civco Medical Solutions | 2016-05-25 |
| FLEX SCORING CATHETER (K152789) | Venturemed Group | 2016-05-25 |
| PIEZOSURGERY PLUS (K153743) | Mectron S.P.A. | 2016-05-25 |
| Creatine Kinase (K160570) | Roche Diagnostics Operations (Rdo) | 2016-05-25 |
| Prometheus ChitoGauze XR PRO (K153582) | Hem Con Medical Technologies, Inc. | 2016-05-25 |
| Penumbra System, Penumbra Pump MAX (K160449) | Penumbra, Inc. | 2016-05-25 |
| Stryker Orthopaedics Hip Systems Labeling Update (K153345) | Stryker Orthopaedics | 2016-05-25 |
| ActTrust (K151784) | Condor Instruments Ltda. - Epp | 2016-05-25 |
| Smartdop XT6 (K153762) | Koven Technology, Inc. | 2016-05-25 |
| EMMa Electronic Monitoring Management (K153477) | Vitasystems GmbH | 2016-05-25 |
| Hypocore (K153162) | Novocor Medical Systems, Inc. | 2016-05-24 |
| Haemonetics Cell Saver Elite Autotransfusion System (K160197) | Haemonetics Corporation | 2016-05-24 |
| Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) (K160533) | Penumbra, Inc. | 2016-05-24 |
| CROSSER CTO Recanalization Catheter (K161208) | Bard Peripheral Vacular, Inc. | 2016-05-24 |
| Agem Ag Mesh Dressing with Silver (K152544) | Shenzhen Yuanxing Nano-Pharma Co., Ltd. | 2016-05-23 |
| PINPOINT Endoscopic Fluorescence Imaging System (K150956) | Novadaq Technologies, Inc. | 2016-05-23 |
| ARTOURA Breast Tissue Expanders with Smooth Surface (K161176) | Mentor Worldwide, LLC | 2016-05-23 |
| INCLUSIVE TAPERED IMPLANT SYSTEM (K153099) | Prismatik Dentalcraft, Inc. | 2016-05-23 |
| Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (K153597) | Healgen Scientific,, LLC | 2016-05-23 |
| Planmeca ProMax 3D Max, Planmeca Maximity (K160506) | Planmeca Oy | 2016-05-20 |
| Temperature Probe, Affinity Temperature Probe (K160091) | Medtronic, Inc. | 2016-05-20 |
| ViZion DR + Wireless (K160810) | Viztek, LLC | 2016-05-20 |
| GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System (K160065) | Gemss Medical Systems Co., Ltd. | 2016-05-20 |
| BIB Stent Placement Catheter (K160889) | NuMED, Inc. | 2016-05-20 |
| everX Posterior (K153127) | GC America, Inc. | 2016-05-20 |
| BardPort®, SlimPort®, and X-Port® Implanted Ports (K153359) | C.R. Bard, Inc. | 2016-05-20 |
| CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes (K160416) | Mauna Kea Technologies | 2016-05-20 |
| Trillium Oval V 5.1 MRI System (K160152) | Hitachi Medical Systems America, Inc. | 2016-05-20 |
| TruAbutment DS (K152559) | Truabutment | 2016-05-20 |
| Microdent Ektos Implant System (K153650) | Implants Microdent System S.L | 2016-05-20 |
| MasterLoc Stem (K160289) | Medacta International | 2016-05-20 |
| United Urologics Closed System Catheter (K160877) | Robling Medical, Inc. | 2016-05-20 |
| Dr. Wolff Vagisan Moisturising Cream (K152507) | Dr. August Wolff GmbH & Co. KG Arzeimittel | 2016-05-20 |
| Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy (K152423) | Sunfire Industries, Inc. | 2016-05-20 |
| Oral-B 5% Sodium Fluoride Varnish (K153334) | Young Dental Manufacturing Co. 1, LLC | 2016-05-20 |
| VITROS Chemistry Products Calibrator Kit 3 (K161140) | Ortho-Clinical Diagnostics, Inc. | 2016-05-20 |
| Baha 5 Power Sound Processor (K161123) | Cochlear Americas | 2016-05-20 |
| Kudu (K151492) | R82 A/S | 2016-05-20 |
| IPS Style Ceram, IPS Style Ceram One, IPS Style Press (K152103) | Ivoclar Vivadent, AG | 2016-05-20 |
| CUR Model 1 (K160052) | Thimble Bioelectronics, Inc. | 2016-05-20 |
| Reliance Lumbar IBF System (K160463) | Reliance Medical Systems, LLC | 2016-05-20 |
| Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System (K153107) | Choicespine, LP | 2016-05-19 |
| Nester Embolization Coils, Tornado Embolization Coils (K153778) | Cook Incorporated | 2016-05-19 |
| WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL (K152842) | Boston Scientific Corporation | 2016-05-19 |
| Navio (K160537) | Blue Belt Technologies, Inc. | 2016-05-19 |
| EMPOWR PS Knee System (K160342) | Encore Medical L.P. | 2016-05-19 |
| Target Detachable Coils (K153658) | Stryker Neurovascular | 2016-05-19 |
| SmartStart Air/Water and Suction Valves (K160403) | Endochoice, Inc. | 2016-05-19 |
| OsteoMed ExtremiLOCK Wrist Plating System (K161041) | Osteomed | 2016-05-19 |
| Filbloc (K150553) | Assut Europe | 2016-05-19 |
| EasyPass Guidewire (K153264) | Medi-Globe Corporation | 2016-05-19 |
| Nanostim Introducer Kit (K161102) | St. Jude Medical, Inc. | 2016-05-19 |
| Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible) (K152466) | Prosurg, Inc. | 2016-05-19 |
| OptiCross X, 40 MHz Coronary Imaging Catheter (K161125) | Boston Scientific Corporation | 2016-05-19 |
| Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200 (K152452) | Medtek Lighting Corp D/B/A Peacock Tanning | 2016-05-19 |
| C2 CryoBalloon Focal Pear Catheter (K160994) | C2 Therapeutics, Inc. | 2016-05-19 |
| Valleylab REM Polyhesive Infant Patient Return Electrode (K160290) | Covidien, LLC | 2016-05-19 |
| Mammo Tomosynthesis (MDMG-5221) (K161229) | Barco N.V. | 2016-05-18 |
| Vario 8/18/ci (K153663) | Medela AG | 2016-05-18 |
| JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector (K160226) | Implanet, S.A. | 2016-05-18 |
| Stryker SDC3 HD Information Management System with Wireless Device Control Capability (K160332) | Stryker Endoscopy | 2016-05-18 |
| SafeCT-29 (K153331) | Medic Vision Imaging Solutions | 2016-05-17 |
| BIOFOAM Bone Wedge (K152062) | Wrightmedicaltechnologyinc | 2016-05-17 |
| PicoSure Workstation (K160480) | Cynosure, Inc. | 2016-05-17 |
| SiO2 Coated syringe 3 ml (K153553) | Sio2 Medical Products | 2016-05-17 |
| GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. (K153716) | Gpc Medical, Ltd. | 2016-05-17 |
| Third Eye Panoramic Auxiliary Endoscopy System - Resposable (K160356) | Avantis Medical Systems, Inc. | 2016-05-17 |
| IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers (K161082) | Immunodiagnostic Systems , Ltd. | 2016-05-17 |
| SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens (K152657) | Smart Performer Corp. , Ltd. | 2016-05-17 |
| Escalade Legend Acetabular Shell (K161080) | Ortho Development Corporation | 2016-05-17 |
| COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS) (K152754) | Biomet Manufacturing Corp | 2016-05-16 |
| Trak Male Fertility Testing System (K153683) | Sandstone Diagnostics, Inc. | 2016-05-16 |
| Aesculap OrthoPilot Next Generation (K153396) | Aesculap Implant Systems, LLC | 2016-05-16 |
| Lumipulse G ROMA (K160090) | Fujirebio Diagnostics,Inc. | 2016-05-16 |
| MagPro R20 (K160280) | Tonica Elektronik A/S | 2016-05-16 |
| SonoSite iViz Ultrasound System (K161119) | FUJIFILM Sonosite, Inc. | 2016-05-13 |
| Diagnostic Imaging Color LCD Monitor (K161057) | Nec Display Solutions , Ltd. | 2016-05-13 |
| Bindex BI-100 (K152020) | Bone Index Finland , Ltd. | 2016-05-13 |
| UltraCor Twirl Breast Tissue Marker (K152510) | Bard Peripheral Vascular, Inc. | 2016-05-13 |
| Astral 100/150 (K152068) | Resmed, Ltd. | 2016-05-13 |
| Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay (K153236) | C.R. Bard, Inc. | 2016-05-13 |
| Cereve Sleep System (DEN140032) | Cereve, Inc. | 2016-05-13 |
| SeraQuest HSV Type 2 Specific IgG (K152353) | Quest International, Inc. | 2016-05-13 |
| EzDent-i / E2 / Prora View (K161117) | Ewoosoft Co., Ltd. | 2016-05-13 |
| ArcCHECK-MR (K160057) | Sun Nuclear Corporation | 2016-05-13 |
| LT-300 HD (K160380) | Lutech Industries, Inc. | 2016-05-13 |
| Perimeter Otis™ 1.0 Optical Coherence Tomography System (K160240) | Perimeter Medical Imaging, Inc. | 2016-05-13 |
| Oasis Lacrimal Intubation Set (K160710) | Anodyne | 2016-05-13 |
| DD medical polymers (K153490) | Dental Direkt GmbH | 2016-05-13 |
| SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator (K153045) | Easy Med Instrument Co., Ltd. | 2016-05-13 |
| AirFit F20 (K153563) | Resmed, Ltd. | 2016-05-13 |
| ALTA Anterior Cervical Interbody Spacer (K160154) | Astura Medical | 2016-05-13 |
| ReNew Sterilization Trays(Catalog #3708 and #3709) (K152745) | Microline Surgical, Inc. | 2016-05-12 |
| GORE DrySeal Flex Introducer Sheath (K160254) | W. L. Gore & Associates, Inc. | 2016-05-12 |
| Guiding Catheter (K153703) | Texasmedical Technologies, Inc. | 2016-05-12 |
| Monoject Enteral Feeding Syringe with ENFit Connector (K160419) | Covidien | 2016-05-12 |
| moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager (K152749) | Moor Instruments, Ltd. | 2016-05-12 |