| Triglycerides (K150819) | Randox Laboratories Limited | 2015-08-06 |
| CAPSTONE Spinal System, CLYDESDALE Spinal System (K151128) | Medtronic Sofamor Danek USA, Inc. | 2015-08-06 |
| O-Arm O2 Imaging System (K151000) | Medtronic, Inc. | 2015-08-06 |
| MultiFIX® P Knotless Fixation Device (K151897) | ArthroCare Corporation | 2015-08-06 |
| ABL80 FLEX CO-OX with AQURE connectivity (K151856) | Sendx Medical, Inc. | 2015-08-06 |
| CPAP Cannulaide (K143700) | Salter Labs | 2015-08-05 |
| Titan (K150086) | Tzora Active Systems , Ltd. | 2015-08-05 |
| COMPACT PIEZO LED (K151023) | Mectron S.P.A. | 2015-08-05 |
| SImmetry Sacroiliac Joint Fusion System (K151818) | Zyga Technology, Inc. | 2015-08-05 |
| NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for Bars/Bridges, NNC Straumann Variobase Abutment for Bars/Bridges, RN Straumann Variobase Abutment for Bars/Bridges, WN Straumann Variobase Abutment for Bars/Bridges (K151157) | Straumann USA, LLC | 2015-08-05 |
| SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEM (K132929) | Sd Biosensor, Inc. | 2015-08-05 |
| AXIOS Stent with Electrocautery Enhanced Delivery System (K150692) | Boston Scientific Corp | 2015-08-05 |
| OPTIS Integrated System Mobile Workstation (K151286) | Lightlab Imaging, Inc. | 2015-08-05 |
| TheraCal DC (K143292) | Bisco, Inc. | 2015-08-04 |
| ForeFoot STP System (K150871) | Tornier, Inc. | 2015-08-04 |
| CareView 1500Cw X-ray Flat Panel Detectors (K150929) | Careray Digital Medical System Co., Ltd. | 2015-08-04 |
| Leksell Gamma Knife Icon (K151561) | Elekta Instrument AB | 2015-08-04 |
| Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical Device, Holster, 15-foot (K150735) | Covidien | 2015-08-04 |
| Models 2200DR and 1600DR Digital Stationary Radiographic Systems (K151219) | Beijing Polycon Medical Engineering Company | 2015-08-04 |
| Bovie J-Plasma Handpiece (K151325) | Bovie Medical Corporation | 2015-08-04 |
| NUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free, Tested for Use with Chemotherapy Drugs (K150973) | Terang Nusa Snd Bhd | 2015-08-04 |
| Venus Legacy CX (K143554) | Venus Concept , Ltd. | 2015-08-04 |
| HI-LIGHT, HI-LIGHT PLUS (K140432) | Dentall Corporation | 2015-08-03 |
| Medtronic Confida Brecker Guidewire (K150465) | Medtronic Core Valve, LLC | 2015-08-03 |
| Metallic Locking Bone Plate and Screw (K142943) | Canwell Medical Co., Ltd. | 2015-08-03 |
| Metacross RX PTA Balloon Dilitation Catheter (K150865) | KANEKA Corporation | 2015-08-03 |
| QuantorView (K151687) | 3Disc Americas | 2015-08-03 |
| PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner (K151053) | Sopro - Acteon Group | 2015-07-31 |
| NIRO-200NX (K143219) | Hamamatsu Photonics K.K. | 2015-07-31 |
| Sniper Spine System (K151813) | Spine Wave, Inc. | 2015-07-31 |
| SyncVision System (K151904) | Volcano Corporation | 2015-07-31 |
| Biomet Spine Fusion System (K151483) | Biomet Spine, LLC | 2015-07-31 |
| Unimicro Veress Needle (K150068) | Unimicro Medical Systems (Shenzhen) Co., Ltd. | 2015-07-31 |
| Arthrex OrthoVis Preoperative Plan (K151568) | Custom Orthopaedic Solutions, Inc. | 2015-07-31 |
| B40i Patient Monitor (K143676) | GE Healthcare Finland Oy | 2015-07-31 |
| OneTouch Verio Flex Blood Glucose Monitoring System (K150214) | Lifescan Europe | 2015-07-31 |
| MagVita TMS Therapy System (K150641) | Tonica Elektronik A/S | 2015-07-31 |
| DIGITEK TITANIUM ABUTMENT (K141970) | Digitek Dental Solutions Limited | 2015-07-31 |
| GME ExSys 308 (K150752) | Gme (German Medical Engineering) GmbH | 2015-07-31 |
| Z5m(t) (K150021) | Z-Systems AG | 2015-07-31 |
| Biogensis Implant System-Kisses (K142813) | Biogenesis Co., Ltd. | 2015-07-31 |
| Zephyr Vascular Compression Device (K151363) | Advanced Vascular Dynamics | 2015-07-31 |
| OCS-B COLLAGEN (K142040) | Nibec Co., Ltd. | 2015-07-31 |
| STRONG Dental Handpieces (K143418) | Saeshin Precision Co., Ltd. | 2015-07-31 |
| HEMO-Bandage (K151204) | Coreleader Biotech Co., Ltd. | 2015-07-31 |
| SmartSite Vented Vial Access Device (K151963) | Yukon Medical, LLC | 2015-07-31 |
| NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) (K150874) | Novo Nordisk, Inc. | 2015-07-31 |
| Durex Silicone (K143532) | Reckitt Benckiser, LLC | 2015-07-31 |
| SmartDrive Wheelchair Power Assist (K151199) | Max Mobility, LLC | 2015-07-30 |
| Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH (K150371) | Diros Technology, Inc. | 2015-07-30 |
| Polypectomy Snare (K150316) | Micro-Tech (Nanjing) Co., Ltd. | 2015-07-30 |
| OneTouch Lubricant Gel (K142790) | Thai Nippon Rubber Industry Co., Ltd. | 2015-07-30 |
| Gemini XXP-HP (K151298) | Dornier Medtech America | 2015-07-30 |
| Infinity ERCP Sampling Device (K151889) | United States Endoscopy Group, Inc. | 2015-07-30 |
| 5MP Monochrome LCD Monitor, RadiForce GX540 (K151883) | Eizo Corporation | 2015-07-30 |
| XenMatrix AB Surgical Graft (K151177) | C. R. Bard | 2015-07-30 |
| Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter (K150107) | Micro Therapeutics Inc Dba Ev3 Neurovascular | 2015-07-29 |
| Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD Monitor, Sony LMD-X550S LCD Monitor, Sony LMD-X550MD LCD, Sony LMD-X550NB LCD Monitor (K150377) | Sony Electronics, Inc. | 2015-07-29 |
| Cream Stretch Vinyl Patient Examination Glove (Non-Sterile),White Vinyl Patient Examination Glove (Non-Sterile), (K143277) | Lifestyle Safety Products (Hui Zhou) Co., Ltd. | 2015-07-29 |
| ECHELON Oval V 5.0 MRI System (K151015) | Hitachi Medical Systems America, Inc. | 2015-07-29 |
| 3D/5D Viewer (K151808) | Samsung Medison Co., Ltd. | 2015-07-29 |
| Atlas SPEEDER Header/Neck (K151829) | Quality Electrodynamics, LLC | 2015-07-29 |
| GenIQ (K143368) | Ge Medical Systems, LLC | 2015-07-29 |
| Cellfina System (K150505) | Ulthera, Inc. | 2015-07-29 |
| LnK Posterior Cervical Fixation System (K143278) | L&K BIOMED Co., Ltd. | 2015-07-29 |
| Barrx Anorectal RFA Wand (K150251) | Covidien, LLC | 2015-07-28 |
| Piccolo Composite Nailing System (K151010) | CarboFix Orthopedics , Ltd. | 2015-07-28 |
| Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA) (K142855) | Omega Laboratories, Inc. | 2015-07-28 |
| Tyber Medical Wedge System (K150394) | Tyber Medical, LLC | 2015-07-28 |
| Bard LubriGuard Foley Catheter (K150699) | C.R. Bard, Inc. | 2015-07-28 |
| Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Contralateral Design; Flexor Up and Over Balkin Contralateral Introducer; Flexor Check-Flo Introducer, Raabe Modification; Flexor Check-Flo Performer Introducer (K142829) | Cook Incorporated | 2015-07-28 |
| Philips Self-Adhesive Electrodes (K151033) | Philips Consumer Lifestyle | 2015-07-28 |
| Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit (K151464) | Alere Scarborough, Inc. | 2015-07-28 |
| Elements (K151150) | Pac-Dent International, Inc. | 2015-07-28 |
| 3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E, X213G2P0E) LCD Display (K151854) | D-View Display Technology Co., Ltd. | 2015-07-28 |
| QBit Series Diagnostic Ultrasound System (K150861) | Chison Medical Imaging Co., Ltd. | 2015-07-28 |
| Smith and Nephew Legion Hinge Knee System (K151118) | Smith & Nephew | 2015-07-28 |
| Hyper-C Anterior Cervical Plate System (K150759) | Degen Medical | 2015-07-28 |
| 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors (K150715) | Tornier, Inc. | 2015-07-28 |
| Axium Detachable Coil System (K151447) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2015-07-28 |
| Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith and Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith and Nephew Suture Anchors - Osteoraptor Suture Anchor, Smith and Nephew Suture Anchors - Twinfix Ultra HA Suture Anchor, Smith and Nephew Suture Anchors - OSTEORAPTOR Curved Suture Anchors, Smith and Nephew Suture Anchors - Ultra Fast-Fix Meniscal Repair System, Ultra Fa (K151105) | Smith & Nephew, Inc. | 2015-07-28 |
| Proton Immobilization Solution (K151207) | Orfit Industries NV | 2015-07-28 |
| QuadraSphere Microspheres (K151187) | Biosphere Medical, S.A. | 2015-07-27 |
| EM25 - glute toning device (K143737) | Hivox Biotek, Inc. | 2015-07-27 |
| Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL) (K150236) | Thermo Fisher Scientific | 2015-07-27 |
| A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device (K150924) | Anchor Innovation Medical (A.I.M.) | 2015-07-27 |
| BD Angiocath IV Catheter, BD Insyte IV Catheter (K151698) | Becton Dickinson Infusion Therapy Systems, Inc. | 2015-07-27 |
| Serenity (K150014) | Sanuthera, Inc. | 2015-07-27 |
| Barricade Embolization Coil System (K151760) | Blockade Medical | 2015-07-27 |
| Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set (K142819) | Cook Incorporated | 2015-07-24 |
| ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh (K150906) | Ehicon, Inc. | 2015-07-24 |
| N-Force Fixation System (K151146) | Innovision, Inc. | 2015-07-24 |
| EPX-Series Mobile X-ray System (K151038) | Ecotron Co., Ltd. | 2015-07-24 |
| OrthoPulse (K143120) | Biolux Research , Ltd. | 2015-07-24 |
| TRU Dental Implant System (K150968) | Sterngold Dental, LLC | 2015-07-24 |
| LOCATOR RTx (K150295) | Zest Anchors, Inc. | 2015-07-24 |
| Straumann® Dental Implant System ¿ Roxolid® SLA Implants (K150938) | Straumann USA, LLC | 2015-07-24 |
| Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions (K143102) | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2015-07-24 |
| RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET (K142129) | Biophor Diagnostics, Inc. | 2015-07-24 |
| Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters (K143193) | Boston Scientific | 2015-07-24 |