| PEEK CUSTOMIZED CRAIAL IMPLANT KIT (K121153) | Stryker | 2012-09-14 |
| OXFORD ANKLE FUSION NAIL(AFN) SYSTEM (K121575) | Ortho Solutions Limited | 2012-09-14 |
| SUPRA SCAN DELIVERY SYSTEM (K120825) | Quantel Medical | 2012-09-14 |
| AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE (K100645) | Medtronic, Inc. | 2012-09-14 |
| METAFIX FEMORAL HIP STEM SIZE 1 (K121439) | Corin USA | 2012-09-14 |
| LULLABY TM WARMER (K121625) | Wipro GE Healthcare Private, Ltd. | 2012-09-14 |
| CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT (K110053) | Smiths Medical Asd, Inc. | 2012-09-14 |
| TRIA LASER HAIR REMOVAL SYSTEM (K120737) | Tria Beauty, Inc. | 2012-09-13 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS (K121774) | Boston Scientific Corp | 2012-09-13 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVE (K112741) | Lifestyle Safty Products (Hui Zhou) Co., Ltd. | 2012-09-13 |
| DX-D FULL LEG FULL SPINE (K122119) | Afga Healthcare N.V. | 2012-09-13 |
| VIRTUOST (K113725) | O.N. Diagnostics | 2012-09-13 |
| AIM (K121479) | Inneroptic Technology, Inc. | 2012-09-13 |
| PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 (K122593) | Optim, LLC | 2012-09-13 |
| VIAMO SSA-640A V4.0 (K122491) | Toshibamedical Systems Corporation | 2012-09-13 |
| LABONACHECK A1C (K111128) | Ceragem International, Inc. | 2012-09-13 |
| VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM (K121078) | Accel Spine | 2012-09-13 |
| STREPTOCOCCUS APP. SEROLOGICAL REAGENTS (K122019) | Meridian Bioscience, Inc. | 2012-09-13 |
| IMMUNOCAP ALLERGEN COMPONENTS BUNDLE (K113841) | Phadia US, Inc. | 2012-09-13 |
| GSI VIEWER WITH VUE OPTION (K121827) | GE Medical Systems SCS | 2012-09-13 |
| PATIENT POSITIONING SYSTEM (K122413) | Forte Automation Systems, Inc. | 2012-09-13 |
| JAZZ SYSTEM (K121541) | Implanet, S.A. | 2012-09-13 |
| VELASHAPE (K122579) | Syneron Medical, Ltd. | 2012-09-13 |
| STERRAD(R) 100NX STERILIZER DUO CYCLE (K111377) | Advanced Sterilization Products | 2012-09-13 |
| G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE (K121335) | Hutchinson Sante S.N.C. | 2012-09-13 |
| CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE (K122427) | Carestream Dental, LLC | 2012-09-12 |
| ALCO-SCREEN 02 (K121256) | Chematics, Inc. | 2012-09-12 |
| LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D LAVA ULTIMATE IMPLANT CROWN RESTOR (K122569) | 3M Company | 2012-09-12 |
| STRYKER VIDEO URETEROSCOPE (K121112) | Stryker Endoscopy | 2012-09-12 |
| PROTECTOR, INJECTOR, CONNECTOR (K120384) | Bd Medical-Medical Surgical Systems | 2012-09-12 |
| NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES (K112693) | Sgmp Co., Ltd. | 2012-09-12 |
| AYCAN MOBILE (K122260) | Aycan Digitalsysteme GmbH | 2012-09-12 |
| VITAL COUGH (K120277) | Lung Assist, Inc. | 2012-09-12 |
| INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS (K120012) | Integra LifeSciences Corporation | 2012-09-11 |
| RANGE SPINAL SYSTEM (K121630) | K2m, Inc. | 2012-09-11 |
| UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT (K121492) | Beckman Coulter, Inc. | 2012-09-11 |
| QUINTEX CERVICAL PLATING SYSTEM (K121801) | Aesculap Implant Systems, LLC | 2012-09-11 |
| SOMATOM DEFINITION (K122471) | Siemens Medical Systems, Inc. | 2012-09-11 |
| VOLUSON P6, VOLUSON P8 (K122387) | GE Healthcare | 2012-09-11 |
| EUROIMMUN ANTI-LKM-1 ELISA(LGG) (K112223) | Euroimmun US | 2012-09-11 |
| TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED) (K120009) | Abbott Laboratories | 2012-09-11 |
| POWDER FREE BLACK NITRILE EXAMINATION GLOVES (K113393) | Tg Medical Sdn. Bhd. | 2012-09-11 |
| EUROIMMUN ANTI-SLA/LP ELISA(LGG) (K112221) | Euroimmun US | 2012-09-11 |
| C2-9-D ULTRASOUND TRANSDUCER (K122515) | GE Healthcare | 2012-09-11 |
| ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION (K120776) | Biomet 3i | 2012-09-11 |
| ROTH NET RETRIEVER (K122462) | United States Endoscopy Group, Inc. | 2012-09-11 |
| ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION) (K120766) | Prosurg, Inc. | 2012-09-11 |
| POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR (K121528) | Shen Wei (Usa), Inc. | 2012-09-11 |
| NUVASIVE PRECEPT SPINAL SYSTEM (K122352) | Nuvasive, Inc. | 2012-09-11 |
| DELICOT (K121822) | American Surgical Company, LLC | 2012-09-10 |
| ESENSOR RESPIRATORY VIRAL PANEL (K113731) | Clinical Micro Sensors, Inc. | 2012-09-10 |
| VISIONS PV .035 DITITAL IVUS CATHETER (K121273) | Volcano Corporation | 2012-09-10 |
| ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5 (K112624) | Roche Diagnostics | 2012-09-10 |
| ETS BLUE POWDER-FREE PATIENT NITRILE EXAMINATION GLOVES (K121947) | Northstar Healthcare Holdings | 2012-09-10 |
| NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (K122363) | Siam Sempermed Corp., Ltd. | 2012-09-10 |
| LANX SPINAL FIZATION SYSTEM (K121316) | Lanx, Inc. | 2012-09-10 |
| TAPERSET HIP SMALL STEMS (K121935) | Consensus Orthopedics, Inc. | 2012-09-10 |
| BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE (K120126) | Barosense, Inc. | 2012-09-10 |
| HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX (K122612) | Maquet Cardiovascular, LLC | 2012-09-10 |
| UNITY TOATAL KNEE SYSTEM (K113060) | Corin USA | 2012-09-10 |
| INTEGRA CAMINO ICP MONITOR (K121573) | Intrgra Lifesciences Corporation | 2012-09-10 |
| EARLYSENSE CENTRAL DISPLAY SYSTEM (K121885) | Earlysense, Ltd. | 2012-09-10 |
| MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK) (K122498) | Hologic, Inc. | 2012-09-10 |
| BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG (K120924) | Corentec Co., Ltd. | 2012-09-10 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K121372) | Andon Health Co, Ltd. | 2012-09-10 |
| MASIMO SET USPO2 PULSE OXIMETRY CABLE (K121914) | Masimo Corporation | 2012-09-07 |
| VITROS CHEMISTRY PRODUCTS DHDL SLIDES (K120609) | Ortho-Clinical Diagnostics, Inc. | 2012-09-07 |
| SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS (K121714) | Smith & Nephew, Inc. | 2012-09-07 |
| INFRARED THERMOMETER (K113761) | Famidoc Technology Co., Ltd. | 2012-09-07 |
| HEMOCUE HBA1C 501 (K121366) | Infopia Co, Ltd. | 2012-09-07 |
| MINIARC PRO SINGLE-INCISION SLING SYSTEM (K121641) | American Medical Systems | 2012-09-07 |
| VITREAVIEW (K122136) | Vital Images, Inc. | 2012-09-07 |
| MINI PATCH (K121353) | Well-Life Healthcare Limited | 2012-09-07 |
| VERACIA (K121749) | Shofu Dental Corporation | 2012-09-07 |
| SNOWDEN PENCER LAPAROSCOPIC ERGONOMIC REPOSABLE SCISSORS (K113407) | Carefusion 2200, Inc. | 2012-09-07 |
| DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM CURVED LINEAR ARRAY 2-5 MHZ TRANSDUCER LINEAR ARRAY 5-11 MHZ TRANSDUCER PHASE ARRA (K121983) | Benq Medical Technology Corpation | 2012-09-07 |
| GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE (K122301) | Vascular Solutions Zerusa , Ltd. | 2012-09-07 |
| MR VESSELLQ XPRESS (K122164) | GE Medical Systems SCS | 2012-09-07 |
| BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B (K121797) | Becton, Dickinson and Company | 2012-09-07 |
| ARROW PICC POWERED BY ARROW VPS STYLET (K121941) | Arrow International (Subsidiary of Teleflex Inc.) | 2012-09-07 |
| B&W DENTAL IMPLANT SYSTEM (K120875) | B&W Srl | 2012-09-07 |
| PONTO BONE ANCHORED HEARING SYSTEM (K121228) | Oticon Medical AB | 2012-09-07 |
| ZYNO MEDICAL ADMINISTRATION SET (K120685) | Zyno Medical, LLC | 2012-09-07 |
| TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM (K113821) | Transonic Systems, Inc. | 2012-09-07 |
| DEPUY CTA REVERSE SHOULDER SYSTEM (K122442) | Depuy France | 2012-09-06 |
| LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELF (K113648) | Aap Implantate AG | 2012-09-06 |
| IMPELLA 2.5 PLUS CATHETER (K112892) | Abiomed, Inc. | 2012-09-06 |
| LOUTREX TOPICAL CREAM (K120730) | Acella Pharmaceuticals, LLC | 2012-09-06 |
| CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM (K121974) | Conformis, Inc. | 2012-09-06 |
| FOCUS TOUCH CONCEPTION SYSTEM (K112200) | Intimate Bridge 2 Conception, Inc. | 2012-09-06 |
| PADLOCK CLIP-12 (K120814) | Aponos Medical Corp. | 2012-09-06 |
| SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES (K122628) | Datascope Corp., Cardiac Assist Division | 2012-09-06 |
| MAXLOCK EXTREME SYSTEM (K122005) | Orthohelix Surgical Designs, Inc. | 2012-09-06 |
| LENSSX LASER SYSTEM (K120732) | Alcon Lensx, Inc. | 2012-09-06 |
| ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE (K121309) | Advanced Surgical Concepts | 2012-09-06 |
| LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM (K122397) | DiaSorin, Inc. | 2012-09-06 |
| BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS (K121787) | BioHorizons Implant Systems, Inc. | 2012-09-05 |
| NEOSS PROACTIVE TAPERED IMPLANT (K113376) | Neoss, Ltd. | 2012-09-05 |
| PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS) (K121383) | Medical Components, Inc. | 2012-09-05 |
| LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON (K122030) | Degania Silicone , Ltd. | 2012-09-05 |