| VASHE WOUND THERAPY SOLUTION (K123072) | Puricore, Inc. | 2013-02-14 |
| CONNECT FOR DA VINCI SURGICAL SYSTEM(S) (K123840) | Intuitive Surgical, Inc. | 2013-02-14 |
| MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATE SYSTEM (K123918) | Zimmer, Inc. | 2013-02-14 |
| MONOJECT 12ML SYRINGE (K130049) | Nipro Medical Corporation | 2013-02-14 |
| SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT (K123240) | ArthroCare Corporation | 2013-02-14 |
| ECG CHECK (K122184) | Cardiac Designs, LLC | 2013-02-14 |
| TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P (K123166) | Howmedica Osteonics Corp. | 2013-02-14 |
| CIRCUFLOW 5208 SEQUENTIAL COMPRESSION DEVICE (K123647) | Devon Medical, Inc. | 2013-02-14 |
| DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM15 SERIES (K120673) | Grandway Technology (Shenzhen) Limited | 2013-02-14 |
| ACON BUP ONE STEP BUPRENORPHINE TEST STRIP (K130055) | Guangzhou Wondfo Biotech Co., Ltd. | 2013-02-14 |
| SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV (K121919) | Exact Medical Manufacturing, Inc. | 2013-02-14 |
| EQUAFLOW MULTIVALVE INFUSION CATHETER (K123235) | Cook Incorporated | 2013-02-14 |
| VITRO MOLAR (K123826) | Dfl Industria E Comercio SA | 2013-02-14 |
| ISO-GARD CLEARAIR MASK (K123176) | Teleflexmedical, Inc. | 2013-02-14 |
| GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS (K121433) | Hmd Biomedical, Inc. | 2013-02-14 |
| MALE LATEX CONDOM (K121241) | Nulatex Sdn. Bhd. | 2013-02-14 |
| RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS (K123412) | K2m, Inc. | 2013-02-13 |
| DOSE TRACKING SYSTEM MODEL XIDF-DTS801 (K123097) | Toshiba America Medical Systems, In.C | 2013-02-13 |
| MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM (K123524) | Medtronic Neurosurgery | 2013-02-13 |
| TRANSFERRIN KIT FOR USE ON THE SPAPLUS (K120236) | The Binding Site Group , Ltd. | 2013-02-13 |
| INTEGRA PROXIMAL HUMERAL PLATE SYSTEM (K121826) | Ascension Orthopedics, Inc. | 2013-02-13 |
| ULTRASOUND SCANNER FLEX FOCUS (K123254) | B-K Medical Aps | 2013-02-13 |
| RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER (K123544) | Ev3, Inc. | 2013-02-12 |
| FORYOU NPWT DEVICE (K113236) | Foryou Medical Electronics Co, Ltd. | 2013-02-12 |
| NEW STETIC ARTIFICIAL TEETH (K122925) | New Stetic | 2013-02-12 |
| MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI (K120663) | Dako North America, Inc. | 2013-02-12 |
| TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS (K123705) | Corin USA | 2013-02-12 |
| GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES (K121877) | Exactech, Inc. | 2013-02-12 |
| ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM (K113614) | Roche Diagnostics | 2013-02-12 |
| INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED (K130209) | Sorin Group Italia S.R.L. | 2013-02-12 |
| STA COMPACT MAX (K130090) | Diagnostica Stago, Incorporated | 2013-02-12 |
| PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM (K130043) | Teleflexmedical, Inc. | 2013-02-12 |
| SYNGO MR B19 FOR MAGNETOM AVANTO, SYNGO MR B19 FOR MAGNETOM ESPREE, SYNGO MR B19 FOR MAGNETOM SYMPHONY A TIM SYSTEM, SYN (K123938) | Siemens Medical Solutions USA, Inc. | 2013-02-12 |
| LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM (K102751) | Ceragem Medisys, Inc. | 2013-02-11 |
| PHONAK TINNITUS BALANCE (K123450) | Phonak, LLC | 2013-02-11 |
| SOLEA (K123494) | Convergent Dental, Inc. | 2013-02-11 |
| CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR) (K123116) | Worldmed Manufacturing Sdn. Bhd. | 2013-02-11 |
| J-SCOPE SYSTEM (K122411) | Myelotec | 2013-02-11 |
| BABYLANCE HEEL INCISION DEVICE (K130132) | Medipurpose Pte. , Ltd. | 2013-02-11 |
| 3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK (K121069) | 3M Company | 2013-02-11 |
| IPL THERAPY SYSTEM (K123435) | Beijing Sincoheren S&T Development Co, Ltd. | 2013-02-11 |
| FILMARRAY RESPIRATORY PANEL (RP) (K123620) | Biofire Diagnostics, Inc. | 2013-02-11 |
| MYOSURE INTRUMENT TRAY (K121280) | Hologic, Inc. | 2013-02-08 |
| 4MP COLOR LCD MONITOR, RADIFORCE RX440 (K130070) | Eizo Nanao Corporation | 2013-02-08 |
| ADENOVIRUS R-GENE US (K121942) | Argene SA | 2013-02-08 |
| 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 AI (K123131) | Tosoh Bioscience, Inc. | 2013-02-08 |
| SURGERY REHEARSAL PLATFORM (K123023) | Surgical Theater, LLC | 2013-02-08 |
| NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS (K112616) | Heinz Kurz GmbH Medizintechnik | 2013-02-08 |
| UNI-GOLD CRYPTOSPORIDIUM (K121565) | Trinity Biotech | 2013-02-08 |
| ALEXIS O WOUND PROTECTOR/RETRACTOR (K113268) | Applied Medical Resources Corp. | 2013-02-08 |
| DIAGNOSTIC ULTRASOUND SYSTEM (K123249) | Edan Instruments, Inc. | 2013-02-08 |
| VICTUS FEMTOSECOND LASER PLATFORM (K122386) | Technolas Perfect Vision GmbH | 2013-02-08 |
| DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE (K122065) | Ormco Corp. | 2013-02-08 |
| COMPACT DIGITAL BLOOD PRESSURE MONITOR (K122810) | Thermor , Ltd. | 2013-02-08 |
| PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR (K123799) | Psychemedics Corp. | 2013-02-08 |
| PROFEMUR TL CLASSIC HIP STEM (K123688) | Wrightmedicaltechnologyinc | 2013-02-08 |
| LINSHI NITRILE DISPOSABLE EXAM GLOVES, POWDER-FREE (K123488) | Puyang Linshi Health Co., Ltd. | 2013-02-08 |
| PULSTAR LOGIX INTERMITTENT PNEUMATIC COMPRESSION SYSTEM (K123308) | Albahealth, LLC | 2013-02-08 |
| OPTIMA CT520 (K123596) | Ge Hangwei Medical Systems Co., Ltd. | 2013-02-08 |
| CORONIS FUSION 6MP (K130103) | Barco N.V. | 2013-02-08 |
| GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT (K120922) | Selectivemed Components, Inc. | 2013-02-07 |
| ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION (K120558) | Lifescan, Inc. | 2013-02-07 |
| GENASIS SCANVIEW SYSTEM (K122554) | Applied Spectral Imaging , Ltd. | 2013-02-07 |
| MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEM (K123206) | Maxim Surgical | 2013-02-07 |
| ESPIN (K130057) | Nlt Spine, Ltd. | 2013-02-07 |
| SPINEOLOGY SPINOUS PROCESS PLATE (K123232) | Spineology, Inc. | 2013-02-07 |
| TOXCUP DRUG SCREEN CUP (K122633) | Branan Medical Corp. | 2013-02-07 |
| 0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE (K121050) | Becton, Dickinson & CO | 2013-02-07 |
| AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE AN (K123216) | Aimago SA | 2013-02-07 |
| ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM (K120708) | Cilag GmbH International | 2013-02-07 |
| M2 WRIST MRI SYSTEM (K120701) | Aspect Imaging, Ltd. | 2013-02-07 |
| XIPHOS (K123969) | Difusion Technologies | 2013-02-07 |
| SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM (K122822) | Spectrum Spine, LLC | 2013-02-07 |
| BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208 (K122587) | St Jude Medical | 2013-02-07 |
| RELIANCE SPINAL SCREW SYSTEM (K123521) | Reliance Medical Systems, LLC | 2013-02-07 |
| OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE (K121818) | Oxford Performance Materials | 2013-02-07 |
| COMPRESSYN STAPLE (K122871) | Dallen Medical, Inc. | 2013-02-07 |
| SHEATHES STERILE ULTRASOUND GEL (K130041) | Sheathing Technologies, Inc. | 2013-02-06 |
| CAAS INTRAVASCULAR (K123970) | Pie Medical Imaging BV | 2013-02-06 |
| EEGER4 MODEL 4.3 (K122879) | Eeg Software, LLC | 2013-02-06 |
| VISUAL-ICE CRYOABLATION SYSTEM (K123865) | Galil Medical, Inc. | 2013-02-06 |
| TRC-NW300 NON-MYDRIATIC RETINAL CAMERA (K123460) | Topcon Medical Systems, Inc. | 2013-02-06 |
| BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP (K122718) | Becton, Dickinson and Company | 2013-02-06 |
| SHERPA PAK CARDIAC TRANSPORT SYSTEM (K123326) | Paragonix Technologies, Inc. | 2013-02-06 |
| GE DATEX-OHMEDA AVANCE CS2 (K123125) | Datex-Ohmeda, Inc. | 2013-02-06 |
| ASAHI REXEED-SX/LX SERIES DIALYZER (K121409) | Asahi Kasei Medical Co., Ltd. | 2013-02-06 |
| APLIO 500/400/300 V3.0 (K123992) | Toshibamedical Systems Corporation | 2013-02-06 |
| VISCOSTAT CLEAR (K123215) | Ultradent Products, Inc. | 2013-02-05 |
| PROFEMUR Z CLASSIC STEMS (K123434) | Wrightmedicaltechnologyinc | 2013-02-05 |
| GIRAFFE AND PANDA WARMERS (K123309) | Ohmeda Medical | 2013-02-05 |
| LIFESPAN EPTFE VASCULAR GRAFT (K130016) | LeMaitre Vascular, Inc. | 2013-02-05 |
| ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE (K123114) | ETHICON, Inc. | 2013-02-05 |
| AUGMENT AND SCREW, PSA TYPE (K122183) | United Orthopedic Corp. | 2013-02-05 |
| A-GRIX TE RESORABLE BONE VOID FILLER (K121453) | Ag Digital Technology Corp. | 2013-02-05 |
| PASS LP SPINAL SYSTEM (K123138) | Medicrea International | 2013-02-05 |
| DIGITAL THERMOMTER (K122520) | Taidoc Technology Corporation | 2013-02-05 |
| CARDEASCREEN (K123217) | Cardea Associates, Inc. | 2013-02-05 |
| RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD (K122781) | Covidien, Formerly US Surgical A Divison of Tyco H | 2013-02-05 |
| PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR (K122805) | Parcus Medical, LLC | 2013-02-05 |
| EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II) (K123050) | Nantong Biotechnology Co., Ltd. | 2013-02-05 |