| Belvedere™ Lateral Plating System (K153097) | Neurostructures, Inc. | 2016-07-15 |
| EPIC ClearView System (DEN150004) | Epic Research & Diagnostics, Inc. | 2016-07-15 |
| FDR Visionary Suite (K152294) | Shimadzu Corporation | 2016-07-15 |
| Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC) (K160031) | Sunrise Medical (Us), LLC | 2016-07-14 |
| LEONI ORION System (K160518) | Leoni Cia Cable System | 2016-07-14 |
| Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device (K160906) | Spineology, Inc. | 2016-07-14 |
| Panpac Disposable Pessary Fitting Set (K153422) | Panpac Medical Corporation | 2016-07-14 |
| PMT Platinum Depthalon Depth Electrode (K151790) | Pmt Corporation | 2016-07-14 |
| Powder Free Grey Vinyl Examination Gloves (K161072) | Zibo Flourish Trading Co., Ltd. | 2016-07-14 |
| Wingman 18 Crossing Catheter (K160848) | Reflow Medical, Inc. | 2016-07-14 |
| ShefaBone SCPC Resorbable Bone Graft (K153230) | The Implantech Inc./Shefabone | 2016-07-14 |
| IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved (K153087) | Ivy Sports Medicine, LLC | 2016-07-14 |
| Soberlink Cellular Device and Sober Sky Web Portal (K160613) | Soberlink Healthcare, LLC | 2016-07-14 |
| Amber Mill Series and Amber Press Series (K160102) | Hass Corp. | 2016-07-14 |
| AmplifEYE (K160846) | Medivators, Inc. | 2016-07-14 |
| Biopor, AOC Porous Polyethylene, Cerepor (K160988) | Ceremed , Inc. | 2016-07-14 |
| t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater (K160482) | Tandem Diabetes Care, Inc. | 2016-07-13 |
| LOOK PTFE Suture (K160744) | Surgical Specialties Corporation | 2016-07-13 |
| E-Cath (K152952) | PAJUNK GmbH Medizintechnologie | 2016-07-13 |
| ActiveCare Home (K160431) | Medical Compression Systems (Dbn) , Ltd. | 2016-07-13 |
| Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens (K160803) | CooperVision, Inc. | 2016-07-13 |
| TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System (K161525) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016-07-13 |
| VALO Grand (K160551) | Ultradent Products, Inc. | 2016-07-13 |
| OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) (K160859) | Contamac, Ltd. | 2016-07-13 |
| PolyDev Soft Contact Lenses (K160977) | Polydev , Ltd. | 2016-07-13 |
| Multi Modality Viewer (K161419) | Vital Images, Inc. | 2016-07-13 |
| EXACTECH GPS (K152764) | Blue Ortho | 2016-07-13 |
| PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory (K161163) | Hitachi , Ltd. | 2016-07-13 |
| SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE (K152803) | Sung Shim Medicare Co., Ltd. | 2016-07-12 |
| Gradia Plus (K153325) | GC America, Inc. | 2016-07-12 |
| E-Pack Procedure Kit (K161726) | ETHICON, Inc. | 2016-07-12 |
| Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 (K161055) | Fuji Dynamics , Ltd. | 2016-07-12 |
| CryoDose H or Similar (K161337) | Nuance Medical, LLC | 2016-07-12 |
| InMode Plus System (K153568) | Inmode MD , Ltd. | 2016-07-12 |
| Apinator (K160123) | Allen J. Moses, Dds, Ltd. | 2016-07-12 |
| Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL (K161175) | Liofilchem s.r.l. | 2016-07-12 |
| RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set (K160077) | Jbw7 Innovations, LLC | 2016-07-12 |
| Penumbra System ACE 68 Reperfusion Catheter (K161640) | Penumbra, Inc. | 2016-07-12 |
| ARTLINE (K160448) | Health Line International Corporation | 2016-07-12 |
| ACE Electrosurgical Resection and Vaporization Electrodes Series (K153055) | Ace Medical Devices Pvt. , Ltd. | 2016-07-11 |
| syngo®.via protoNeo (Version VA10A) (K161685) | Siemens Healthcare GmbH | 2016-07-11 |
| PROW FUSION-V (K153786) | Nlt Spine, Ltd. | 2016-07-11 |
| PASS OCT Spinal System (K161149) | Medicrea International SA | 2016-07-11 |
| Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula (K152511) | Prosurg, Inc. | 2016-07-11 |
| JSM Insulin Pen Needle (K152166) | Jeesung Medical Co., Ltd. | 2016-07-11 |
| MLX™ - Medial Lateral Expandable Lumbar Interbody System (K153105) | Nu Vasive, Incorporated | 2016-07-11 |
| Pulse H20h! (K152628) | Toaster Labs, Inc. | 2016-07-11 |
| Pulse Aloe-ahh (K152671) | Toaster Labs, Inc. | 2016-07-11 |
| PeriCoach OTC (K160758) | Analytica, Ltd. | 2016-07-11 |
| Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating (K160875) | Cardinal Health, Inc. | 2016-07-11 |
| da Vinci Xi Surgical System (K161271) | Intuitive Surgical, Inc. | 2016-07-11 |
| INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set (K153272) | Relievant Medsystems | 2016-07-09 |
| BD U-500 INSULIN SYRINGE (K151870) | Becton, Dickinson and Company | 2016-07-08 |
| AccuLIF TL and PL Cage (K160715) | Stryker Corporation | 2016-07-08 |
| The Time Machine Series Lasers (K152461) | Medical Lasers Manufacturer, Inc. | 2016-07-08 |
| Savannah-T® Pedicle Screw System (K152920) | Amendia, Inc. | 2016-07-08 |
| sensiLight Mini (K161089) | El Global Trade, Ltd. | 2016-07-08 |
| S-scan (K161238) | Esaote, S.p.A. | 2016-07-08 |
| PlasmaBlade TnA Tonsil and Adenoid Dissection Device (K152703) | Medtronic Advanced Energy | 2016-07-08 |
| HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls (K153137) | Instrumentation Laboratory CO | 2016-07-08 |
| Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments (K153700) | Aesculap Implant Systems, LLC | 2016-07-08 |
| Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System (K161192) | Zimmer GmbH | 2016-07-08 |
| TightRail Sub-C Rotating Dilator Sheath (K161333) | Spectranetics, Inc. | 2016-07-08 |
| ULTRASHAPE POWER SYSTEM (K160896) | Syneron Medical, Ltd. | 2016-07-08 |
| AcceleDent Aura (K153048) | Orthoaccel Technologies, Inc. | 2016-07-08 |
| Alta ACDF System (K152622) | Biomet Spine | 2016-07-08 |
| i-STAT Alinity System with i-STAT Sodium test (K153357) | Abbott Point of Care, Inc. | 2016-07-08 |
| LITe BIO Delivery System (K160978) | Stryker Corporation | 2016-07-08 |
| Styrker OrthoMap Express Knee System (K153240) | Stryker Corporate | 2016-07-07 |
| Cydar EV (K160088) | Cydar , Ltd. | 2016-07-07 |
| Habib EUS RFA (K161305) | Emcision , Ltd. | 2016-07-07 |
| AirLife Adult Heated Wire Circuit (K153234) | Carefusion, Inc. | 2016-07-07 |
| Gemini Sterilization Wrap (K152564) | Medline Industries, Inc. | 2016-07-07 |
| CorticaLINK Spinal Fusion Platform (K160722) | Facetlink Dba Linkspine | 2016-07-07 |
| RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR (K161345) | Sedecal., Sa. | 2016-07-06 |
| FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE (K161314) | Flexicare Medical Limited. | 2016-07-06 |
| G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer (K153231) | GC America, Inc. | 2016-07-06 |
| Integra External Fixation System (K160830) | Ascension Orthopedics | 2016-07-06 |
| SPEC Model M13 (K161395) | Source Production and Equipment Co., Inc. | 2016-07-06 |
| V-PRO® 1 Plus and V-PRO® maX Low Temperature (K160433) | STERIS Corporation | 2016-07-06 |
| Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm (K160996) | Dunamis, LLC | 2016-07-06 |
| SunTech CT40 Spot-check Vital Signs Device (K160439) | Suntech Medical | 2016-07-06 |
| GC85A (K160997) | Samsung Electronics Co., Ltd. | 2016-07-06 |
| Full Automatic (NIBP) Blood Pressure Monitor (K160557) | Health & Life Co., Ltd. | 2016-07-06 |
| Easy-Load Lens Delivery System (K161012) | Bausch and Lomb, Inc., | 2016-07-06 |
| BD SafeAssist (K161553) | Becton, Dickinson and Company | 2016-07-06 |
| Voyant Fine Fusion (K153017) | Applied Medical Resources | 2016-07-06 |
| LD-Oxi system (K160956) | Ld Technology, LLC | 2016-07-06 |
| NeuGuide (K160569) | Pop Medical Solutions | 2016-07-06 |
| AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) (K161044) | Assure Tech. (Hangzhou) Co, Ltd. | 2016-07-06 |
| Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal (K153074) | Covidien | 2016-07-06 |
| Cool Renewal (K161296) | Cool Renewal, LLC | 2016-07-06 |
| PicoWay Laser System (K160607) | Syneron Candela Corporation | 2016-07-05 |
| LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System (K160947) | Usa Laser Biotech, Inc. | 2016-07-05 |
| Lumipulse G TP-N Immunoreaction Cartridge Set (K153145) | Fujirebio Diagnostics,Inc. | 2016-07-05 |
| Tearaway Introducer Sheath, MicroSlide Tearaway Introducer (K153533) | Galt Medical Corp. | 2016-07-05 |
| LightStim Professional LED Bed (K153399) | Led Intellectual Properties, LLC | 2016-07-05 |
| Expedium Spine System, VIPER and VIPER 2 Systems (K160904) | Medos International SARL | 2016-07-01 |
| IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800 (K161531) | Philips Medizin Systeme Boeblingen GmbH | 2016-07-01 |
| Sorbact Foam Gentle Border, Sorbact Superabsorbent (K153674) | Abigo Medical AB | 2016-07-01 |