| PC ECG (K161302) | Edan Instruments, Inc. | 2016-07-01 |
| INDIGO Aspiration System (K161523) | Penumbra, Inc. | 2016-07-01 |
| Cure™ Anterior Cervical Plate (ACP) System (K160604) | Meditech Spine, LLC | 2016-07-01 |
| LIAISON EBV IgM Serum Control Set (K161522) | DiaSorin, Inc. | 2016-06-30 |
| Arthrosurface Bone Screws (K161539) | Arthrosurface, Inc. | 2016-06-30 |
| CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (K161556) | Centers For Disease Control and Prevention (CDC) | 2016-06-30 |
| ViaValve Safety I.V. Catheter (K160235) | Smiths Medical Asd, Inc. | 2016-06-30 |
| RTHawk, HeartVista Cardiac Package (K153740) | Heartvista, Inc. | 2016-06-30 |
| Identic and KromaFaze Alginate Dental Impression Materials (K160441) | Kerr Corporation | 2016-06-30 |
| Initial LiSi Press (K153136) | GC America, Inc. | 2016-06-30 |
| 3 Series Phototherapy Unit (K153749) | Daavlin Distributing Company | 2016-06-30 |
| LIAISON CMV IgM Serum Control Set (K161526) | DiaSorin, Inc. | 2016-06-30 |
| Lelo Hex Natural Rubber Latex Condom (K160644) | Lelo, Inc. | 2016-06-30 |
| Relizorb (K161247) | Alcresta Therapeutics, Inc. | 2016-06-30 |
| VITA ENAMIC Implant Solutions (IS) (K153645) | Vita Zahnfabrik H.Rauter GmbH Co. | 2016-06-30 |
| STERIZONE Sterilizer (K153689) | Tso3, Inc. | 2016-06-30 |
| Repagyn vaginal suppositories (K153372) | Farma-Derma S.R.L. | 2016-06-30 |
| Admira Fusion Flow (K153177) | Voco GmbH | 2016-06-30 |
| ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) (K161495) | Luminex Corporation | 2016-06-30 |
| MySpine Pedicle Screw Placement Guides - LP (K153273) | Medacta International S.A. | 2016-06-29 |
| Lite Touch (K152737) | Focus Medical, LLC | 2016-06-29 |
| BloodSTOP iX Battle Matrix (K160130) | Lifescience Plus, Inc. | 2016-06-29 |
| ADMIRE (K153360) | Siemens Medi Cal Solutions, Inc. | 2016-06-29 |
| HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length (K160752) | Ethicon Endo-Suregery, LLC | 2016-06-29 |
| ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material (K151986) | Siemens Healthcare Diagnostics, Inc. | 2016-06-29 |
| Nustat XR (K160578) | Beeken Biomedical, LLC | 2016-06-29 |
| Ablation Confirmation (K161285) | Neuwave Medical, Inc. | 2016-06-29 |
| Vent-Os Sinus Dilation family (K160770) | Sinusys Corporation | 2016-06-29 |
| OPTIS Metallic Stent Optimization E.4 SW (K160878) | Lightlab Imaging, Inc. | 2016-06-29 |
| ally Liquid Personal Lubricant (K160763) | Private Label Production, LLC | 2016-06-29 |
| Spinal Jaxx Interbody Fusion Device (K152501) | Neuropro Spinaljaxx, Inc. | 2016-06-29 |
| Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter) (K161186) | Fujifilm Medical Systems U.S.A, Inc. | 2016-06-29 |
| Xpert Carba-R (K160901) | Cepheid | 2016-06-29 |
| Jeesung Safety Syringe and Single Use Needles (K152606) | Jeesung Medical Co., Ltd. | 2016-06-28 |
| VIDAS B.R.A.H.M.S. PCT (PCT) (K160911) | bioMerieux, Inc. | 2016-06-28 |
| CoRoent® Ti-C System (K160916) | Nu Vasive, Incorporated | 2016-06-28 |
| SCATTER CORRECTION FOR CXDI SERIES (K153312) | Canon, Inc. | 2016-06-28 |
| MRI Patient Monitor TeslaDUO (K153739) | Mipm Mammendorfer Institut Fur Physik Und Medizin | 2016-06-28 |
| Regular and Special Umbilical Cord Clamp and Cutter (K152350) | Ningbo Feite Medical Device Co., Ltd. | 2016-06-28 |
| PowerMidline Catheter (K153393) | C.R. Bard, Inc. | 2016-06-28 |
| Gibralt® Spine System and Gibralt® Occipital Spine System (K160697) | Exactech, Inc. | 2016-06-28 |
| LED Curing Light GT-2000 (K153078) | Monitex Industrial Co., Ltd. | 2016-06-28 |
| Nanovis Intervertebral Body Fusion System and FortiCore® (K160874) | Nanovis, LLC | 2016-06-28 |
| Surgical Navigation Advanced Platform (SNAP) (K160584) | Surgical Theater, LLC | 2016-06-28 |
| hipEOS (K161479) | Onefit Medical | 2016-06-28 |
| PressON Pro Spinal Fixation System (K160820) | Nexus Spine, LLC | 2016-06-28 |
| F1 MPS Modular Pedicle Screw System (K160926) | Degen Medical | 2016-06-28 |
| Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape (K161024) | Canadian Technical Tape, Ltd. | 2016-06-28 |
| Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode (K151976) | Omnitech Systems, Inc. | 2016-06-27 |
| Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard) (K161214) | Guangzhou Wondfo Biotech Co., Ltd. | 2016-06-27 |
| Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System (K160853) | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2016-06-27 |
| EndoChoice Water Bottle Cap Irrigation System (K161482) | Endochoice, Inc. | 2016-06-27 |
| Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer (K153692) | Infrared Laboratory Systems, LLC (Dba Synermed) | 2016-06-24 |
| Radixact Treatment Delivery System (K161146) | Accuray Incorporated | 2016-06-24 |
| Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) (K152122) | Alfa Scientific Designs, Inc. | 2016-06-24 |
| AnyPlus® Cervical PEEK Cage System (K153517) | GS Medical Co., Ltd. | 2016-06-24 |
| Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System (K160430) | Ascensia Diabetes Care U.S., Inc. | 2016-06-24 |
| SMR Shoulder System (K161476) | Lima Corporate S.P.A. | 2016-06-24 |
| Liger Medical HTU-110 (K152843) | Liger Medical, LLC | 2016-06-24 |
| Naya Breast Pump System (K160511) | Naya Health, Inc. | 2016-06-24 |
| CareEvent inclusive of the CareEvent Mobile Application accessory (K161164) | Philips Medical Systems | 2016-06-24 |
| Unifine Pentips/ Unifine Pentips Plus (K152339) | Owen Mumford, Ltd. | 2016-06-24 |
| Digital Blood Pressure Monitor (K153033) | Suzhou Sunspiri Co., Ltd. | 2016-06-24 |
| ClariFix Device (K160669) | Arrinex, Inc. | 2016-06-24 |
| SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System (K153201) | Sd Biosensor | 2016-06-24 |
| Precision Treatment Planning System (K161136) | Accuray Incorporated | 2016-06-24 |
| BrightMatter Guide with BrightMatter Pointer (K160523) | Synaptive Medical, Inc. | 2016-06-24 |
| Single Use Surgical Suction Irrigator (K161421) | Jiangsu Haize Medical Scientific Development Co., Ltd. | 2016-06-24 |
| Ultrathane Endoureterotomy Stent Set (K160891) | Cook Incorporated | 2016-06-24 |
| iDMS Data Management System (K161144) | Accuray Incorporated | 2016-06-24 |
| Resmon PRO FULL (K152585) | Medical Graphics Corp. | 2016-06-24 |
| The Life Spine Subtalar Implant System (K160169) | Life Spine | 2016-06-23 |
| FitRite™ Total Hip Arthroplasty System (K153057) | Excera Orthopedics, Inc. | 2016-06-23 |
| NC Quantum Apex PTCA Dilatation Catheter (K160823) | Boston Scientific Corporation | 2016-06-23 |
| NIO-P (K160805) | Waismed, Ltd. | 2016-06-23 |
| Kuvia3D (K161559) | 4qimaging, LLC Dba Qmetrics | 2016-06-23 |
| QiF Blood and Fluid Warmer (K150404) | Quality IN Flow , Ltd. | 2016-06-23 |
| Synthetic Vinyl Examination Gloves, Powder-Free, Yellow (K160468) | Inpro Technology Device Factory | 2016-06-23 |
| CELALUX 3 (K153018) | Voco GmbH | 2016-06-23 |
| Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter (K153006) | Sterilmed, Inc. | 2016-06-23 |
| SANDMAN ELITE (K153353) | Embla Systems | 2016-06-23 |
| Collagen Dental Wound Dressings (K152600) | Collagen Matrix, Inc. | 2016-06-23 |
| EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented (K152937) | Eco Medi Glove Sdn. Bhd. | 2016-06-23 |
| FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM (K160540) | Flexicare Medical Limited. | 2016-06-23 |
| Quiver Laparoscopic Extendable (K153472) | Itl Corporation Pty, Ltd. | 2016-06-23 |
| JustRight Surgical Vessel Sealing System (K160602) | Justright Surgical | 2016-06-23 |
| StatStrip Xpress Blood Glucose Monitoring System (K160156) | Nova Biomedical Corporation | 2016-06-23 |
| Latera Absorbable Nasal Implant (K161191) | Spirox, Inc. | 2016-06-23 |
| Chocolate XD PTCA Balloon Catheter (K153682) | Trireme Medical, LLC | 2016-06-23 |
| Portable Slit Lamp (K153545) | Shanghai Bolan Optical-Electric Co., Ltd. | 2016-06-22 |
| Portable ECG Monitor (K152863) | Contec Medical Systems Co.,Ltd | 2016-06-22 |
| Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml (K153569) | Liofilchem s.r.l. | 2016-06-22 |
| NERBRIDGE (K152967) | Toyobo Co., Ltd. | 2016-06-22 |
| PolypVac Microdebrider (3.3mm and 4.0mm) (K161101) | Laurimed, LLC | 2016-06-22 |
| IMPAX Volume Viewing 4.0 (K161061) | Agfa Healthcare N.V. | 2016-06-22 |
| Target Detachable Coils (K161429) | Stryker Neurovascular | 2016-06-22 |
| OptiCross 18, 30 MHz Peripheral Imaging Catheter (K160514) | Boston Scientific Corporation | 2016-06-22 |
| CliniCloud Non-contact Thermometer, Model SPL1024 (K161325) | Stethocloud Pty.Ltd (Clinicloud) | 2016-06-22 |
| ASAHI Fielder XT-A, ASAHI Fielder XT-R (K153106) | Asahi Intecc Co., Ltd. | 2016-06-21 |
| DBSWIN and VistaEasy Imaging Software (K161444) | Duerr Dental AG | 2016-06-21 |