| Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+ (K150347) | Deltex Medical Limited | 2015-07-24 |
| ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST (K141427) | Accumetrics, Inc. | 2015-07-24 |
| TENEO Dental Treatment Unit and Accessories (K151045) | Sirona Dental Systems GmbH | 2015-07-24 |
| SureLock W Suture Anchor (K151068) | Cayenne Medical, Inc. | 2015-07-24 |
| IV Administration Sets with 200(micro)m Blood Filter (K143082) | B.Braun Medical, Inc. | 2015-07-24 |
| Medline ENFit Connectors (K151628) | Medline Industries, Inc. | 2015-07-24 |
| Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets (K151395) | Immunalysis Corporation | 2015-07-24 |
| O Glide Personal Lubricant (K142726) | Grafenberg Labs | 2015-07-24 |
| Dentis Dental Implant System (K150344) | Dentis Co., Ltd. | 2015-07-24 |
| Powder-Free Yellow Vinyl Patient Examination Gloves (K143347) | Zibo Zhouheng Plastic Products Co., Ltd. | 2015-07-24 |
| TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS (K141289) | Teco Diagnostics | 2015-07-24 |
| Halo (K150486) | J & J Solutions, Inc. D/B/A/ Corvida Medical | 2015-07-24 |
| KYPHON ELEMENT Inflatable Bone Tamp (K151532) | Medtronic, Inc. | 2015-07-23 |
| Magellan Robotic System (K151730) | Hansen Medical, Inc. | 2015-07-23 |
| TRANSONIC TISSUE PERFUSION MONITOR (K140740) | Transonic Systems, Inc. | 2015-07-23 |
| CinchLock Flex Knotless Suture Anchor (K151314) | Pivot Medical | 2015-07-23 |
| Muscle Stimulation System 110 (K150742) | Niveus Medical, Inc. | 2015-07-23 |
| iuStar300 Medical Ultrasound Diagnostic System (K141720) | United Imaging Systems (Beijing) Co., Ltd. | 2015-07-23 |
| ORL Video NasoPharyngo-Larngoscope (K150248) | Jedmed Instrument Company | 2015-07-23 |
| PROTOCOL Incision Dressing (K142962) | Deroyal Industries | 2015-07-23 |
| RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port Device (K143133) | Smith & Nephew, Inc. | 2015-07-23 |
| Q6 Edge EM (K143383) | Pride Mobility Product Corporation | 2015-07-23 |
| Digital Automatic Blood Pressure Monitor MD2300 (K143735) | Grandway Technology (Shenzhen) Limited | 2015-07-23 |
| E-CUBE 15 Diagnostic Ultrasound System (K150773) | Alpinion Medical Systems Co., Ltd. | 2015-07-23 |
| Powder-Free White Vinyl Patient Examination Gloves (K143346) | Zibo Changda Plastic Products Company, Limited | 2015-07-22 |
| PATHWAY ELIF (K143143) | Custom Spine, Inc. | 2015-07-22 |
| iFuse Implant System (K150875) | SI-BONE, Inc. | 2015-07-22 |
| Ventilation (Tympanostomy) Tubes (K151067) | Medtronic Xomed, Inc. | 2015-07-22 |
| Rampart-T Interbody Fusion System (K151020) | Spineology, Inc. | 2015-07-22 |
| TM-ABI system (K143152) | Ld Technology, LLC | 2015-07-22 |
| CoSense ETCO Monitor (K151107) | Capnia, Inc. | 2015-07-22 |
| Zeramic Adhesive Resin Cement (K150601) | Premier Dental Company Products | 2015-07-22 |
| Cordelle II Sound Processor (K150751) | Cochlear Americas | 2015-07-22 |
| LaserCap LC Pro and LC Elite (K150613) | Transdermal Cap, Inc. | 2015-07-22 |
| Retracta Detachable Embolization Coil (K151676) | Cook Incorporated | 2015-07-22 |
| Nutra Light Advanced (K150370) | Nutra Luxe MD, LLC | 2015-07-22 |
| ELITech Clinical Systems CALCIUM ARSENAZO (K151113) | Elitechgroup | 2015-07-22 |
| Caiman Seal and Cut Technology (K151858) | Aesculap, Inc. | 2015-07-21 |
| PulseRelief (K151035) | Philips Consumer Lifestyle | 2015-07-21 |
| MiNi Internal Implant System (K150537) | Megagen Implant Co., Ltd. | 2015-07-21 |
| Mosaic Universal Composite (K151094) | Ultradent Products, Inc. | 2015-07-21 |
| Flexi-Seal Signal Fecal Management System (K150350) | Convatec, Ltd. | 2015-07-21 |
| DENTCA DENTURE BASE (K143033) | Dentca, Inc. | 2015-07-21 |
| Cloud9 System (K150365) | Insleep Technologies, LLC | 2015-07-21 |
| NovoStitch Plus Meniscal Repair System (K143356) | Ceterix Orthopaedics, Inc. | 2015-07-21 |
| TENS AND POWERED MUSCLE STIMULATOR (K143268) | Shenzhen As-Tec Technology Co., Ltd. | 2015-07-21 |
| CooperSurgical Advincula Delineator Uterine Manipulator (K143650) | CooperSurgical, Inc. | 2015-07-21 |
| Cortex Laser System (K150587) | Cynosure, Inc. Dba Ellman | 2015-07-21 |
| Medline Natural Lubricating Liquid (K143322) | Medline Industries, Inc. | 2015-07-20 |
| Caiman Seal and Cut Technology (K151696) | Aesculap, Inc. | 2015-07-20 |
| Trojan Riviera Personal Lubricant (K150886) | Church & Dwight Co., Inc. | 2015-07-20 |
| Evacore Fully Disposable Vacuum Assist Biopsy Device (K150088) | Pin-Point Care Corp. | 2015-07-20 |
| Micro well group culture dish, 9-well; Micro well group culture dish, 16-well (K150756) | Hertart | 2015-07-20 |
| NEODENT IMPLANT SYSTEM (K141777) | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015-07-20 |
| Exactech Alteon Monobloc Revision Stem (K150066) | Exactech, Inc. | 2015-07-20 |
| Visi Mobile Monitoring System, Visi Mobile Chest Sensor (K142827) | Sotera Wireless, Inc. | 2015-07-20 |
| EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i (K151707) | Rayence Co., Ltd. | 2015-07-19 |
| GUA60A, GU60A-65 (K151685) | Samsung Electronics Co., Ltd. | 2015-07-17 |
| A-CIFT SoloFuse (K151198) | Spinefrontier, Inc. | 2015-07-17 |
| ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks (K151659) | Covidien, LLC | 2015-07-17 |
| 3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90 (K150839) | Varian Medical Systems, Inc. | 2015-07-17 |
| The Moses Express appliance (K142651) | Allen J. Moses, Dds, Ltd. | 2015-07-17 |
| Hi-Light Diagnostic Ultrasound Systems (K151709) | Qingdao Hisense Medical Equipment Co., Ltd. | 2015-07-17 |
| CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX (K150245) | GE Healthcare Finland Oy | 2015-07-17 |
| PROW FUSION (K151654) | Nlt Spine, Ltd. | 2015-07-17 |
| SURGISEAL Topical Skin Adhesvie (K150866) | Adhezion Biomedical, LLC | 2015-07-17 |
| Medrobotics Flex System (K150776) | Medrobotics Corporation | 2015-07-17 |
| Lotus Series 4 Ultrasonic Surgical System & Accessories (K151101) | Sra Developments, Ltd. | 2015-07-17 |
| ProMIS Fixation System (K150380) | Premia Spine, Ltd. | 2015-07-17 |
| INTEGO Family and Accesories (K150909) | Sirona Dental Systems GmbH | 2015-07-17 |
| Coronis Uniti (K151505) | Barco N.V. | 2015-07-17 |
| ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material (K143687) | Siemens Healthcare Diagnostics, Inc. | 2015-07-17 |
| Capnostream 35 Portable Respiratory Monitor (K150272) | Oridion Medical 1987 , Ltd. | 2015-07-17 |
| UltraLinq (K143176) | Ultralinq Healthcare Solutions, Inc. | 2015-07-17 |
| illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10 (K151046) | Meridian Bioscience, Inc. | 2015-07-17 |
| Biograph mCT and mCT Flow PET/CT Scanners (K151486) | Siemens Medical Solutions USA, Inc. | 2015-07-17 |
| IntelliVue Patient Monitor (K151681) | Philips Medizin Systeme Boeblingen GmbH | 2015-07-17 |
| Refobacin Bone Cement R (K150850) | Biomet, Inc. | 2015-07-16 |
| Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC (K150953) | Bio Compression Systems, Inc. | 2015-07-16 |
| 2014 InterActive/SwishActive System (K143011) | Implant Direct Sybron Manufacturing, LLC | 2015-07-16 |
| ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCare (K151377) | Medical Compression System (Dbn) , Ltd. | 2015-07-16 |
| Alere i Instrument, Alere i Influenza A & B, Alere i Strep A (K151690) | Alere Scarborough, Inc. | 2015-07-16 |
| GC Ortho Connect, GC Ortho Etching Gel (K150128) | Gc Orthodontics America, Inc. | 2015-07-16 |
| RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device (K151326) | Smith & Nephew, Inc. | 2015-07-16 |
| MultiFIX S Knotless Fixation System (K151660) | ArthroCare Corporation | 2015-07-16 |
| Virtuoso System for IHC PR (1E2) using iScan HT (K142965) | Ventana Medical Systems, Inc. | 2015-07-16 |
| Uncoated Tubing and Connector Components (K151523) | Medtronic, Inc. | 2015-07-16 |
| EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine (K151557) | Nantong Egens Biotech Co., Ltd. | 2015-07-16 |
| PROPENCIL Smoke Pencil (K143103) | Bio Protech, Inc. | 2015-07-16 |
| MedSource ClearSafe Safety IV Catheter (K150611) | Medsource International | 2015-07-15 |
| Monster Screw System (K151418) | Paragon 28 | 2015-07-15 |
| The VersaJet II Hydrosurgery System (K143115) | Smith & Nephew, Inc. | 2015-07-15 |
| LnK Cervical Interbody Fusion Cage System (K151677) | L&K BIOMED Co., Ltd. | 2015-07-15 |
| ILUMIEN OPTIS (K150878) | Lightlab Imaging, Inc. | 2015-07-15 |
| AT235 (K151616) | Interacoustics A/S | 2015-07-15 |
| St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology Catheter (K151622) | St Jude Medical | 2015-07-15 |
| ACP 1 Anterior Cervical Plating System (K150700) | Stryker Corporation | 2015-07-15 |
| BA400 14mm Abutment (K150555) | Cochlear Americas | 2015-07-15 |
| EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural (K150903) | Maanshan Bond Medical Instruments Co., Ltd. | 2015-07-15 |
| OsteoMed Cannulated Screw System (K151021) | Osteomed Corp. | 2015-07-15 |