| s-Clean Tapered II RBM Implant System (K160213) | Dentis Co., Ltd. | 2016-06-21 |
| OEC Elite MiniView (K160131) | Ge Hangwei Medical Systems Co., Ltd. | 2016-06-21 |
| Aquarius Stoma Measuring Device (K152246) | Degania Silicone , Ltd. | 2016-06-21 |
| Advanced Medical Imaging Software Suite (KSWVWR) (K160334) | Keosys Sas | 2016-06-21 |
| ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set (K153652) | Teleflex, Inc. | 2016-06-21 |
| Acne Light Therapy Wand (K160691) | Zuko, Inc. | 2016-06-21 |
| Masimo Root Monitoring System and Accessories (K153225) | Masimo Corporation | 2016-06-21 |
| Gold Anchor (K160209) | Naslund Medical AB | 2016-06-21 |
| Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator (K161134) | Bovie Medical Corporation | 2016-06-20 |
| Lehman Manometry Catheter (K160170) | Wilson-Cook Medical, Inc. | 2016-06-20 |
| REBOA Balloon Catheter (K160598) | NuMED, Inc. | 2016-06-20 |
| V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... (K160451) | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2016-06-20 |
| BI IMAGE-X EVOLUTION (K160458) | Radiotecnologia Industrial S.A. DE C.V. | 2016-06-20 |
| RCT700 (K160525) | Ray Co., Ltd. | 2016-06-20 |
| RADspeed Pro (K152244) | Shimadzu Corporation | 2016-06-20 |
| DermaTherapy Bed Linens (K152884) | Precision Fabrics Group, Inc. | 2016-06-20 |
| Kerrison Rongeurs (K152734) | Vitalitec Medizintechnik GmbH | 2016-06-18 |
| CenterCross Ultra Catheter (K160681) | Roxwood Medical, Inc. | 2016-06-17 |
| S698 Symbioz flow (K153367) | Sopro - Acteon Group | 2016-06-17 |
| Withings Thermo (Model SCT01) (K160544) | Withings | 2016-06-17 |
| CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System (K153374) | Orthocare | 2016-06-17 |
| Sol-M Insulin Syringe, Sol-M TB Syringe (K153537) | Sol-Millennium Medical, Inc. | 2016-06-17 |
| Image Navigator by Immuno Concepts (K160265) | Immuno Concepts, N.A. , Ltd. | 2016-06-17 |
| Monoject (K161045) | Covidien | 2016-06-17 |
| EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector (K161003) | Boston Scientific Corporation | 2016-06-17 |
| NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL) (K161039) | Neomed, Inc. | 2016-06-17 |
| SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long (K152771) | Sumitomo Bakelite Co., Ltd. | 2016-06-17 |
| Quantib Brain 1 (K153351) | Quantib B.V. | 2016-06-17 |
| BinaxNOW G6PD Test (K161364) | Alere Scarborough, Inc. | 2016-06-17 |
| Cervical Stand Alone System (K161280) | Orthofix, Inc. | 2016-06-17 |
| Sophono Bone Conduction Systems (S) Configuration and (M) Configuration (K153391) | Sophono, Inc. | 2016-06-16 |
| United Urologics Intermittent Catheter (K160795) | Robling Medical | 2016-06-16 |
| Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit (K160819) | The Binding Site Group , Ltd. | 2016-06-16 |
| PreSep Oligon Oximetry Catheter (K160645) | Edwards Lifesciences, LLC | 2016-06-16 |
| silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL (K153076) | Teleflexmedical, Inc. | 2016-06-16 |
| Endoform Reconstructive Template (K153632) | Aroa Biosurgery Limited (Formerly Mesynthes Limited) | 2016-06-16 |
| ECG CT Gating Device (K160350) | Neocoil, LLC | 2016-06-16 |
| StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis (K160071) | Biomet, Inc. | 2016-06-16 |
| ZUK Select Knee System (K160738) | Smith & Nephew, Inc. | 2016-06-15 |
| Sonic Window (K161342) | Analogic Corporation | 2016-06-15 |
| Tria Sapphire (K160821) | Tria Beauty, Inc. | 2016-06-15 |
| ROMA Calculation Tool Using Elecsys Assays (K153607) | Roche Diagnostics | 2016-06-15 |
| Dentivera Milling Disc (K160498) | Dental Solutions, LLC | 2016-06-15 |
| LightLas Multi-Wavelength Medical Laser System (K152688) | Lightmed Corporation | 2016-06-15 |
| Disposable Surgical Face Mask (K153496) | Xiantao Rayxin Medical Products Co., Ltd. | 2016-06-15 |
| NormaTec PCD-T and PCD-B (K161346) | NormaTec Industries, LP | 2016-06-15 |
| ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control (K153730) | Abbott Laboratories | 2016-06-15 |
| BiZact Open Sealer/Divider (K160539) | Covidien | 2016-06-15 |
| PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter (K151985) | C.R. Bard, Inc. | 2016-06-14 |
| Megapulse III Shortwave Diathermy (K153456) | Accelerated Care Plus | 2016-06-14 |
| Symphion Endoscope and Symphion Cervical Sheath (K160751) | Boston Scientific | 2016-06-14 |
| ASAHI Corsair Armet (K161362) | Asahi Intecc Co., Ltd. | 2016-06-14 |
| ally Warming Liquid Personal Lubricant (K160717) | Private Label Production, LLC | 2016-06-14 |
| Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution (K160627) | Qfix | 2016-06-14 |
| Disposable Hot Biopsy Forceps (K160625) | Micro-Tech (Nanjing) Co., Ltd. | 2016-06-14 |
| Full Automatic (NIBP) Blood Pressure Monitor (K161156) | Health & Life Co., Ltd. | 2016-06-14 |
| ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) (K161366) | Conformis, Inc. | 2016-06-14 |
| Airborne Phototherapy Light (K160238) | International Biomedical | 2016-06-14 |
| M3290B Philips IntelliVue Information Center iX (K153702) | Philips Medical Systems | 2016-06-13 |
| Magnetic Surgical System (DEN150007) | Levita Magnetics International Corp | 2016-06-13 |
| Arrow Quickflash Arterial Catheterization Device (K160018) | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2016-06-13 |
| Medline Singe Patient Use Blood Pressure Cuff (K161035) | Medline Industries, Inc. | 2016-06-13 |
| NR Recorder (K161062) | Norav Medical GmbH | 2016-06-13 |
| Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 (K160729) | Roche Diagnostics | 2016-06-13 |
| illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 (K160829) | Meridian Bioscience, Inc. | 2016-06-13 |
| Cranial COVER (K160739) | Neos Surgery S.L | 2016-06-12 |
| Penumbra System ACE 68 Reperfusion Catheter (K161064) | Penumbra, Inc. | 2016-06-12 |
| NeuroStar TMS Therapy System (K160703) | Neuronetics, Inc. | 2016-06-10 |
| VersaWrap Tendon Protector (K160364) | Alafair Biosciences, Inc. | 2016-06-10 |
| DSG Threaded Drill System (K152747) | Spineguard S.A. | 2016-06-10 |
| BLUEPRINT Patient Specific Instrumentation (K160555) | Tornier S.A.S. | 2016-06-10 |
| Arsenal Spinal Fixation System (K161363) | Alphatec Spine, Inc. | 2016-06-10 |
| Aequalis PerFORM+ Shoulder System (K160975) | Tornier, Inc. | 2016-06-10 |
| DIEGO ELITE DRILL (K152744) | Gyrus Acmi, Inc. | 2016-06-10 |
| Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz (K160095) | Simple Science, LLC | 2016-06-10 |
| MaxO2ME (K153659) | Maxtec, LLC | 2016-06-10 |
| Reprocessed Inquiry Steerable Diagnostic EP Catheter (K160496) | Innovative Health, LLC | 2016-06-10 |
| NEOVIEW Plating System (K160995) | In2bones Sas | 2016-06-10 |
| Endobronchial Tube (K152251) | Henan Tuoren Medical Device Co., Ltd. | 2016-06-10 |
| Pall-Aquasafe Water Filter (K153434) | Pall International Sarl | 2016-06-10 |
| ATTUNE Revision Knee System (K160700) | Depuy(Ireland) | 2016-06-10 |
| Masimo O3 Regional Oximeter System (K160526) | Masimo Corporation | 2016-06-09 |
| Oak Ridge Products Sharps Containers (K161180) | Oak Ridge Products, LLC | 2016-06-09 |
| Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T (K160618) | Ge Medical Systems, LLC | 2016-06-09 |
| HEPATIQ 1.1 (K161188) | Hepatiq, LLC | 2016-06-09 |
| Lucent Intervertebral Body Fusion Device (K152011) | Spinal Elements, Inc. | 2016-06-09 |
| BSD4343 Digital Flat Panel X-ray Detector (K160204) | Bontech, Inc. | 2016-06-09 |
| NuVasive® Reline® System (K160989) | Nu Vasive, Incorporated | 2016-06-09 |
| MAKO 7 (K160510) | Nvision Medical Corporation | 2016-06-09 |
| BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer (K160370) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016-06-09 |
| ATOVEN-Reusable Laser Fiber (K152667) | Diotech CO | 2016-06-09 |
| Aquilion ONE (TSX-305A/3) V7.3 (K160587) | Toshibamedical Systems Corporation | 2016-06-09 |
| 3M Attest Rapid Readout Biological Indicator (K160546) | 3M Company | 2016-06-09 |
| MILAGRO ADVANCE PEEK Interference Screw (K161001) | Medos International SARL | 2016-06-09 |
| Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover (K152342) | St Jude Medical | 2016-06-09 |
| ProteXsure Safety Capsule System (K152597) | Starcap Medical, LLC ( Dba Prism Medical & Design) | 2016-06-08 |
| Miromatrix Biological Mesh (K160400) | Miromatrix Medical, Inc. | 2016-06-08 |
| MAIA (K153181) | Centervue S.P.A. | 2016-06-08 |
| Sony IP Converter NU-IP40S (K161122) | Sony Electronics, Inc. | 2016-06-08 |
| PEDIATRIC VISION SCANNER (DEN130051) | Rebiscan, Inc. | 2016-06-08 |