| Lung Analysis Software (K151283) | Vital Images, Inc. | 2015-10-30 |
| RECON system-V-TEK-IVP Plates and Screws (K152312) | Normed Medizin-Technik GmbH | 2015-10-30 |
| Cardinal Health Sterilization Wrap (K151788) | Cardinal Health200, LLC | 2015-10-30 |
| Lumenis Smart532 Laser System (K151109) | Lumenis, Inc. | 2015-10-30 |
| Elliquence Electrodes (K142410) | Elliquence, LLC | 2015-10-30 |
| STERRAD CYCLESURE 24 Biological Indicator (K151971) | Advanced Sterilization Products | 2015-10-29 |
| OPTIS Mobile System (K152120) | Lightlab Imaging, Inc. | 2015-10-29 |
| Impulse Angiographic Catheter, Expo Angiographic Catheter (K152605) | Boston Scientific Corporation | 2015-10-29 |
| Physica PS Knee System (K152008) | Lima Corporate S.P.A. | 2015-10-29 |
| FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution (K152129) | Baxter Healthcare Corporation | 2015-10-29 |
| M9/M9CV/M9T Diagnostic Ultrasound System (K152543) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-10-29 |
| MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL (K143582) | Resorba Medical GmbH | 2015-10-29 |
| Leksell Gamma Knife Perfexion (K151159) | Elekta Instrument AB | 2015-10-29 |
| ARROW Humeral stems size 6 and 16 (K150568) | Fournitures Hospitalieres Industrie | 2015-10-29 |
| AVAmax Vertebral Balloon (K150523) | Care Fusion | 2015-10-29 |
| DSM Biomedical DPR Cable (K143716) | Dsm Biomedical | 2015-10-29 |
| IPS Ivocolor (K151894) | Ivoclar Vivadent, AG | 2015-10-29 |
| Integra DigiFuse Cannulated Intramedullary Fusion System (K152527) | Ascension Orthopedics | 2015-10-29 |
| Small Bone Nail Implant (K151456) | Vilex IN Tennessee, Inc. | 2015-10-29 |
| PENTAX Medical EKP-i5010 Video Processor with EB Family (K143727) | Pentax of America, Inc. | 2015-10-29 |
| Disposable Blood Pressure Cuff (K152465) | Shenzhen Vistar Medical Supplies Co., Ltd. | 2015-10-29 |
| Wire Sterilization Package with Indicators (K143117) | American Orthodontics | 2015-10-29 |
| ALAR Nasal Valve Stent (K151758) | Medtronic Xomed, Inc. | 2015-10-29 |
| T3 Software (K151715) | Etiometry, Inc. | 2015-10-29 |
| Pavati Zirconia (K151875) | Ccri, Inc. | 2015-10-29 |
| Oravan Herbst (K152159) | Oravanosa, LLC | 2015-10-29 |
| iFuse Implant System (K151718) | SI-BONE, Inc. | 2015-10-29 |
| Reusable Blood Pressure Cuff (K152468) | Shenzhen Vistar Medical Supplies Co., Ltd. | 2015-10-29 |
| Optiflux dialyzer (K152367) | Fresenius Medical Care North America | 2015-10-29 |
| INSTRUMENT CASSETTE (EFCCL1-F) (K141854) | Osung Mnd Co., Ltd. | 2015-10-29 |
| EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER (K152675) | Baxter Healthcare | 2015-10-29 |
| Tempus IC2 (K152124) | Remote Diagnostics Technologies, Ltd. | 2015-10-28 |
| Cavex Cream Alginate (K151535) | Cavex Holland BV | 2015-10-28 |
| Ultraviolet Lamps Intended for Use in Sunlamp Products (commonly known as metal halide sunlamps) (K152095) | Cosmedico Light, Inc. | 2015-10-28 |
| VERTEX(r) Reconstruction System (K152338) | Medtronic Sofamor Danek USA, Inc. | 2015-10-28 |
| Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator (K141876) | Pasture Pharma Pte, Ltd. | 2015-10-28 |
| JOURNEY II Uni Tibial Base and Insert (K152315) | Smith & Nephew, Inc. | 2015-10-28 |
| VS3-IR system (K152204) | Visionsense, Ltd. | 2015-10-28 |
| Rainbow Trans (K151723) | Genoss | 2015-10-28 |
| Genesys Spine TiLock2 Spinal System (K152039) | Genesys Spine | 2015-10-28 |
| RiverLon (Nylon) Suture (K152795) | Riverpoint Medical | 2015-10-28 |
| Guardian 1000 (K151629) | Quanta System Spa | 2015-10-27 |
| A7 Anesthesia System (K151954) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-10-27 |
| ULTRACHECK SPACELABS ABP CUFF-CHILD, ULTRACHECK SPACELABS ABP CUFF-SMALL ADULT, ULTRACHECK SPACELABS ABP CUFF-ADULT, ULTRACHECK SPACELABS ABP CUFF-LARGE ADULT (K152801) | Statcorp Medical | 2015-10-27 |
| Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts (K152169) | Ortho Development Corporation | 2015-10-27 |
| Codman Certas Plus Programmable Valve (K152152) | Medos International SARL | 2015-10-27 |
| Genesis II XLPE Resurfacing Patellar Components (K150241) | Smith & Nephew, Inc. | 2015-10-27 |
| SIGNA Pioneer (K153003) | GE Healthcare | 2015-10-27 |
| Acetabular Cup Orientation System (K150780) | Materialise NV | 2015-10-27 |
| Anchorage 2 CP System (K151769) | Stryker GmbH | 2015-10-27 |
| BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit (K152870) | Becton, Dickinson and Co. | 2015-10-27 |
| CD HORIZON Spinal System (K152457) | Medtronic Sofamor Danek USA, Inc. | 2015-10-27 |
| Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M (K152363) | Philips Medical Systems | 2015-10-27 |
| Express SD Biliary Monorail Premounted Stent System (K152607) | Boston Scientific | 2015-10-27 |
| ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe (K143306) | Erbe USA, Inc. | 2015-10-27 |
| BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit (K152874) | Becton, Dickinson and Co. | 2015-10-27 |
| PremiPatch PTFE Pledget (K151865) | Aesculap, Inc. | 2015-10-27 |
| Varian Treatment (VTx) (K151882) | Varian Medical Systems, Inc. | 2015-10-26 |
| Resection Electrodes (K152092) | Olympus Winter & Ibe GmbH | 2015-10-26 |
| PolarCath Peripheral Dilatation System (K152665) | Nucyro Vascular, LLC | 2015-10-26 |
| Volpara Imaging Software (K152028) | Matakina Technologies Limited | 2015-10-26 |
| ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set (K150270) | Tosoh Bioscience, Inc. | 2015-10-26 |
| Retrieval bag system (K151489) | Beacon Surgical, Inc. | 2015-10-26 |
| LiquiBand Exceed (K151182) | Advanced Medical Solutions (Plymouth), Ltd. | 2015-10-26 |
| Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive (K150606) | Siemens Healthcare Diagnostics, Inc. | 2015-10-23 |
| RF20000a Controller, FLOW 50 Wand (K143235) | ArthroCare Corporation | 2015-10-23 |
| Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart (K152106) | VATECH Co., Ltd. | 2015-10-23 |
| Cellvizio 100 Series System with Confocal Miniprobes (K151593) | Mauna Kea Technologies | 2015-10-23 |
| illumigene Mycoplasma DNA Amplification Assay (K152800) | Meridian Bioscience, Inc. | 2015-10-23 |
| geko T-2 Neuromuscular Stimulator (K152677) | Firstkind Limited | 2015-10-23 |
| LightStim Professional 2-Panel Light (K151336) | Led Intellectual Properties, LLC | 2015-10-23 |
| Vantage Titan 3T (K152371) | Toshibamedical Systems Corporation | 2015-10-23 |
| FEMTO LDV Z8 Surgical Laser (K150323) | Sie Ag,Surgical Instrument Engineering | 2015-10-23 |
| SureClip (K150936) | Conmed Corporation | 2015-10-23 |
| ICS CHARTR EP 200 WITH VEMP (K143670) | Gn Otometrics A/S | 2015-10-23 |
| Bard Snare Retrieval Kit (K152560) | Neometrics, Inc. | 2015-10-23 |
| Medentika CAD/CAM Abutments (K150203) | Medentika GmbH | 2015-10-23 |
| ER-REBOA Catheter (K151821) | Pryor Medical Devices, Inc. | 2015-10-23 |
| Avitus Bone Harvester (K152474) | Avitus Orthopaedics, Inc. | 2015-10-23 |
| Orthodontics Bracket (K150141) | Speed Dental Co., Ltd. | 2015-10-23 |
| R-40 EEG Amplifier (K151600) | Lifelines , Ltd. | 2015-10-23 |
| Masimo MightySat Rx Fingertip Pulse Oximeter (K150314) | Masimo Corporation | 2015-10-22 |
| TSolution One w/ACG surgical System (K150741) | THINK Surgical, Inc. | 2015-10-22 |
| Pacel Bipolar Pacing Catheters (K152784) | St Jude Medical | 2015-10-22 |
| WorkMate Claris System, WorkMate Claris System Display Plus (K151911) | St Jude Medical | 2015-10-22 |
| Carbamazepine Gen 4 (K151578) | Roche Diagnostics Operations (Rdo) | 2015-10-22 |
| P.R.O. CG Manual Wheelchair (K151893) | Freedom Designs, Inc. | 2015-10-22 |
| Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle (K151895) | Boston Scientific Corporation | 2015-10-22 |
| DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive (K152096) | ETHICON, Inc. | 2015-10-22 |
| C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic (K151386) | Atrium Medical Corporation | 2015-10-22 |
| 330psi Extension Y-Line with Dual Check Valve (K150902) | Coeur, Inc. | 2015-10-22 |
| PEAK (K152180) | Neosil Co., Ltd. | 2015-10-22 |
| Philips IntelliVue GuardianSoftware (K151736) | Philips Medizin Systeme Boblingen GmbH | 2015-10-21 |
| ClearPoint System (K142505) | Mri Interventions, Inc. | 2015-10-21 |
| NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK (K151836) | Hartalega NGC Sdn. Bhd. | 2015-10-21 |
| Diamondback 360 Peripheral Orbital Atherectomy System (K152694) | Cardiovascular Systems, Inc. | 2015-10-21 |
| Luminesse Anterior Zirconia AT (K152066) | Talladium, Inc. | 2015-10-21 |
| H-MAX S Femoral Hip System (K150855) | Lima Corporate S.P.A. | 2015-10-21 |
| iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement System (K152704) | Conformis, Inc. | 2015-10-21 |
| CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels (K152693) | Boston Scientific Corporation | 2015-10-21 |