| Microcyn Plus Wound Care Solution (K161034) | Oculus Innovative Sciences | 2016-08-19 |
| 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle (K162030) | Sol-Millennium Medical, Inc. | 2016-08-19 |
| Wireless Smart Gluco-Monitoring System (K153278) | Andon Health Co, Ltd. | 2016-08-19 |
| DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak (K161287) | Medtronic Vascular | 2016-08-19 |
| Streamline 6495 Bipolar Temporary Myocardial Pacing Lead (K161249) | Medtronic | 2016-08-19 |
| Sentinella 102, Sentinella 102 Horus (K162052) | General Equipment For Medical Imaging (Oncovision- | 2016-08-18 |
| Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems (K153651) | Beckman Coulter, Inc. | 2016-08-18 |
| Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit (K161375) | Alere Scarborough, Inc. | 2016-08-18 |
| Fingertip Pulse Oximeter (K152091) | Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd. | 2016-08-18 |
| PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set (K153440) | C.R. Bard, Inc. | 2016-08-18 |
| Medke Oximetry Finger Sensor (K152390) | Shenzhen Medke Technology Co., Ltd. | 2016-08-18 |
| S-Wire Guidewire System (K153397) | Concert Medical, LLC | 2016-08-18 |
| SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System (K162045) | FUJIFILM Sonosite, Inc. | 2016-08-18 |
| Reprocessed Compression Garments (K161105) | Covidien | 2016-08-18 |
| Vein Clamps, Artery Clamps (K161315) | Aros Surgical Instruments Corporation | 2016-08-18 |
| Bullfrog Micro-Infusion Device (K161402) | Mercator Medsystems, Inc. | 2016-08-18 |
| Uroview FD (K161019) | Pausch Medical GmbH | 2016-08-17 |
| Just Like Me Personal Lubricant (K161385) | Wtfn-Dba Classic Erotica/Holiday Products | 2016-08-17 |
| Accent XL (K160075) | Alma Lasers, Inc. | 2016-08-17 |
| Alians Elbow Locking Plating System (K152289) | Newclip Technics | 2016-08-17 |
| SPEC Model M23 (K161396) | Source Production and Equipment Co., Inc. | 2016-08-17 |
| LUOFUCON Silicone Ag foam dressing (K160022) | Huizhou Foryou Medical Devices Co., Ltd. | 2016-08-17 |
| Sumitomo Proton Therapy System (K160612) | Sumitomo Heavy Industries, Ltd. | 2016-08-17 |
| UST-5550-R; UST-5536-R; L43K (K152126) | Hitachi Aloka Medical America, Inc. | 2016-08-17 |
| Ambu USR, Ambu M (K160766) | Ambu A/S | 2016-08-17 |
| Wrist Pulse Oximeter (K152089) | Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd. | 2016-08-17 |
| PACS CORE/ENCORE (K161518) | Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. | 2016-08-17 |
| SUPRIA w/guideShot Option (K161748) | Hitachi Medical Systems America, Inc. | 2016-08-17 |
| First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline) (K160793) | W.H.P.M., Inc. | 2016-08-17 |
| WebPAX (K152949) | Heart Imaging Technologies, LLC | 2016-08-17 |
| A.R.C. Laser Surgical Fibers and Probes (K161403) | A.R.C Laser GmbH | 2016-08-16 |
| The Braun ThermoScan® 3 High Speed Compact Ear Thermometer (K161933) | Kaz USA, Inc., A Helen of Troy Company | 2016-08-16 |
| PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C (K161445) | Adapta Medical, Inc. | 2016-08-16 |
| MC1 Plus (K161502) | General Project S.R.L. | 2016-08-16 |
| Sydney IVF Gamete Buffer (K153478) | William A. Cook Australia Pty. , Ltd. | 2016-08-15 |
| Oral Surgery System and Accessories (K152125) | Bonart Co., Ltd. | 2016-08-15 |
| PressureWire X Guidewire (K161171) | St. Jude Medical, Inc. | 2016-08-15 |
| Dell UP3216Q with QUBYX PerfectLum bundle (K162196) | Qubyx Software Technologies, Inc. | 2016-08-15 |
| Tarsa-Link Stand-Alone Wedge Fixation System (K161037) | Life Spine, Inc. | 2016-08-15 |
| Solana Trichomonas Assay (K161182) | Quidel Corporation | 2016-08-15 |
| Distal Radius Plating System (K161292) | Miami Device Solutions, LLC | 2016-08-15 |
| EMS-200 (K153285) | Meta Systems Co., Ltd. | 2016-08-12 |
| LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp (K160331) | Covidien | 2016-08-12 |
| Raycell Mk2 (K161324) | Best Theratronics Limited | 2016-08-12 |
| ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls (K153375) | Abbott Laboratories | 2016-08-12 |
| EUROIMMUN Anti-West Nile Virus ELISA (IgM) (K153308) | Euroimmun Us, Inc. | 2016-08-12 |
| ECG100+, ECG200+ (K160840) | Cardioline S.P.A | 2016-08-12 |
| Perifix and Contiplex Catheter (K153297) | B.Braun Medical, Inc. | 2016-08-12 |
| Thermi RF Accessories (K161661) | Thermi | 2016-08-12 |
| RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems (K161210) | Medtronic Sofamor Danek | 2016-08-12 |
| SUPERCATH 6 (K160592) | Togo Medikit Co., Ltd. | 2016-08-12 |
| CELTRA Press (K161269) | Dentsply Sirona | 2016-08-12 |
| 'cottony' II TAPE, PLEDGETS (K153089) | Teleflexmedical, Inc. | 2016-08-12 |
| Aer-O-Scope Colonoscope System (K161791) | Gi View , Ltd. | 2016-08-11 |
| Athena Breast Pump (K161266) | Exploramed Nc7, Inc. | 2016-08-11 |
| Laparoscopic Spray Applicator with Spinning Luers (K162077) | Micromedics, Inc. (D/B/A Nordson Medical) | 2016-08-11 |
| VSI StraitSet micro-introducer kit (K161336) | Vascular Solutions, Inc. | 2016-08-11 |
| Discovery MI (K161574) | Ge Medical Systems, LLC | 2016-08-11 |
| Salto XT, Salto Talaris (K153452) | Tornier S.A.S. | 2016-08-11 |
| Adhesive Electrodes (K160138) | Gmdasz Manufacturing Co., Ltd. | 2016-08-11 |
| NICO TRIOwand (K162075) | Nico Corporation | 2016-08-11 |
| Converge (K153573) | Biomedical Enterprises, Inc. | 2016-08-11 |
| OT EQUATOR (K160382) | Rhein'83 Srl | 2016-08-11 |
| VivoSight Dx Topical OCT System (K153283) | Michelson Diagnostics, Ltd. | 2016-08-11 |
| SACCADOMETER PLUS, SACCADOMETER ADVANCED (K152890) | Ober Consulting Sp. Z.O.O. | 2016-08-11 |
| Response BandLoc Spinal Fixation (K161267) | OrthoPediatrics Corp. | 2016-08-11 |
| LensGiene Sterile Saline Solution (K161622) | Optics Laboratory, Inc. | 2016-08-11 |
| Rhythm View Workstation (non-streaming) (K161240) | Abbott Electrophysiology | 2016-08-10 |
| CT TrueView (K160147) | Philips Medical Systems Nederland B.V. | 2016-08-10 |
| EUROIMMUN Anti-West Nile Virus ELISA (IgG) (K153303) | Euroimmun Us, Inc. | 2016-08-10 |
| TAP 3, TAP 1 (K160239) | Airway Management, Inc. | 2016-08-10 |
| Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengths (K160516) | Varian Medical Systems, Inc. | 2016-08-10 |
| Fully Automatic Electronic Blood Pressure Monitor (K160565) | Andon Health Co, Ltd. | 2016-08-10 |
| SpotLight CT (K161066) | Arineta , Ltd. | 2016-08-10 |
| Audit MicroControls Linearity DROP LQ Blood Glucose (K161874) | Aalto Scientific, Ltd. | 2016-08-10 |
| 5D Viewer (K161955) | Samsung Medison Co., Ltd. | 2016-08-10 |
| Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses (K161100) | Contamac, Ltd. | 2016-08-10 |
| MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® (K160648) | Unomedical A/S | 2016-08-10 |
| Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 (K152834) | Colonplus Equipments & Speculums, S.L. | 2016-08-10 |
| Hidrocor, Hidrocharme, and Natural Colors (K160472) | Solotica | 2016-08-10 |
| Affirm Lateral Arm Upright Biopsy Accessory (K161575) | Hologic | 2016-08-10 |
| SnoreRx (K153200) | Apnea Sciences Corporation | 2016-08-09 |
| ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control (K153596) | Ark Diagnostics, Inc. | 2016-08-09 |
| icobrain (K161148) | Icometrix | 2016-08-09 |
| Quantitative Electrocardiographic Detector (QED 2000) (K152135) | Acme Portable Machines, Inc. | 2016-08-09 |
| Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet (K160787) | Syncro Medical Innovations, Inc. | 2016-08-09 |
| Genesys Spine TiLock Cortical Spinal System (K161914) | Genesys Spine | 2016-08-09 |
| Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) (K152224) | Ion Beam Application S.A. | 2016-08-09 |
| NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm) (K161026) | Marvao Medical Devices, Ltd. | 2016-08-09 |
| P-ARTIS (K160611) | P-Cure, Ltd. | 2016-08-08 |
| WoundClot9 (K160679) | Core Scientific Creation , Ltd. | 2016-08-08 |
| PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove (K153678) | Permeaderm, Inc. | 2016-08-08 |
| Cerafix Dura Substitute (K161278) | Acera Surgical, Inc. | 2016-08-08 |
| Philips Ingenuity CT (K160743) | Philips Medical Systems (Cleveland), Inc. | 2016-08-08 |
| BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial (K161306) | Becton Dickinson | 2016-08-08 |
| Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet (K153709) | Devicor Medical Products, Inc. | 2016-08-08 |
| Apollo Balloon Dilatation Catheter (K153742) | Brosmed Medical Co., Ltd. | 2016-08-08 |
| Steerable Guide Catheter (K161985) | Abbott Vascular | 2016-08-07 |
| da Vinci Xi Surgical System (K153276) | Intuitive Surgical, Inc. | 2016-08-07 |
| Verza Guidance System (K160806) | CIVCO Medical Instruments Co., Inc. | 2016-08-05 |