| CROSSFIX II MEMISCAL REPAIR DEVICE (K121413) | Cayenne Medical, Inc. | 2012-06-04 |
| MACH BRACKETS BRIGHT BRACKETS (K120471) | World Bio Tech Co., Ltd. | 2012-06-04 |
| FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US (K121035) | Fujifilm Medical System U.S.A., Inc. | 2012-06-04 |
| BROWNE ALDAHOL GLUTARALDEHYDE INDICATOR (K120435) | STERIS Corporation | 2012-06-04 |
| TRILLIANT SURGICAL K-WIRES (K121008) | Trilliant Surgical, Ltd. | 2012-06-04 |
| LIGHT FOR WRINKLES (K120775) | Led Intellectual Properties, LLC | 2012-06-04 |
| SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM (K120689) | Synthes (USA) Products, LLC | 2012-06-04 |
| S-250 PROTON BEAM RADIATION THERAPY SYSTEM (K120676) | Mevion Medical Systems | 2012-06-04 |
| SNORKEL (K112766) | Fellmar Company | 2012-06-04 |
| THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE (K120661) | Vidacare Corporation | 2012-06-03 |
| MINI-LAP BIPOLAR ELECTROCAUTERY DEVICES (K113597) | Minilap Technologies | 2012-06-03 |
| THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE (K121135) | Thd Spa | 2012-06-01 |
| KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR (K120672) | Andon Health Co, Ltd. | 2012-06-01 |
| VIRTUSO SYSTEM FOR IHC (DO-7) (K121350) | Ventana Medical Systems, Inc. | 2012-06-01 |
| CLEANER ROTATIONAL THROMBECTOMY SYSTEM (K120346) | Rex Medical | 2012-06-01 |
| COLLAGEN WOUND DRESSING (K112580) | Dalim Tissen Co., Ltd. | 2012-06-01 |
| SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS (K112900) | Lima Corporate S.P.A. | 2012-06-01 |
| STRUCTUR 3 (K120779) | Voco GmbH | 2012-06-01 |
| POWERGLIDE MIDLINE CATHETER (K121073) | C.R. Bard, Inc. | 2012-06-01 |
| VANTAGE TITAN (K120638) | Toshibamedical Systems Corporation | 2012-06-01 |
| STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM, 12.0MM / 4.1MM RN, 1.8MM, 14.0MM ... (K111798) | Sterngold Dental, LLC | 2012-06-01 |
| BORRELIA BURGDORFERI IGM BLOT TEST (K113846) | Gold Standard Diagnostics | 2012-06-01 |
| ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT (K113438) | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-06-01 |
| CARDINAL HEALTH DURABLUE STERILIZATION WRAP (K120542) | Cardinal Health-Medical Products and Services | 2012-06-01 |
| LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS (K120763) | Lin-Zhi International, Inc. | 2012-06-01 |
| SYNAPSE 3D NODULE ANALYSIS (K120679) | Fujifilm Medical Systems U.S.A, Inc. | 2012-06-01 |
| MRSA/SA ELITE MGB (K112937) | Elitech | 2012-06-01 |
| SR SUITE 1.0 (K121345) | Halifax Biomedical, Inc. | 2012-06-01 |
| GETINGE 700HC-E SERIES STEAM STERILIZER (K120441) | Getinge Sourcing, LLC | 2012-05-31 |
| CLEAN AND BOOST (K120620) | Apex Dental Materials, Inc. | 2012-05-31 |
| SPECTRUM V.0 (K121023) | Intrinsic Medical Imaging | 2012-05-31 |
| NCI SPATULA (K110734) | Fischer Surgical, Inc. | 2012-05-31 |
| CELVER (K111382) | Cellulose Concepts, LLC | 2012-05-31 |
| OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ (K121307) | Exactech, Inc. | 2012-05-31 |
| KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER (K120944) | Covidien | 2012-05-31 |
| ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT (K120033) | Kci USA, Inc. | 2012-05-31 |
| CLOSER TO NATURE (K121322) | Mayborn Group Limited | 2012-05-31 |
| GUIDEMIA (K121466) | Guidemia Technologies, LLC | 2012-05-31 |
| TANDEMHEART FEMORAL ARTERIAL CANNULA SET (K120543) | Cardiacassist, Inc. | 2012-05-30 |
| SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM (K113739) | Materialise Dental NV | 2012-05-30 |
| SOMNODENT G2 (K121340) | Somnomed, Inc. | 2012-05-30 |
| ERAPID NEBULIZER SYSTEM (K112859) | Pari Respiratory Equipment, Inc. | 2012-05-30 |
| ENDOSCOPIC RETRIEVAL DEVICE (K120084) | United States Endoscopy Group, Inc. | 2012-05-30 |
| WIS1000 (K112621) | Foreseeson Custom Displays, Inc. | 2012-05-30 |
| 3M SPOTON TEMPERATURE MONITORING SYSTEM (K120412) | Arizant Healthcare, Inc. | 2012-05-30 |
| SOLOHEALTH STATION (K113402) | Solohealth, Inc. | 2012-05-30 |
| STAINLESS STEEL SPINAL SYSTEM (K120829) | Theken Spine, LLC | 2012-05-30 |
| BD EMERALD SAF-T SINGLE USE, HYPODERMIC (K121283) | Becton, Dickinson and Company | 2012-05-30 |
| KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT (K111956) | Kronus Market Development Associates, Inc. | 2012-05-30 |
| SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE (K120882) | Bard Access Systems, Inc. | 2012-05-30 |
| NERIA MULTI SUBCUTANEOUS INFUSION SET (K120395) | Unomedical Devices S.A DE C.V. | 2012-05-30 |
| HAMILTON-C1 (K120574) | Hamilton Medical AG | 2012-05-30 |
| ARTISAN SPACE MAINTENANCE SYSTEM (K120271) | Medtronic Sofamor Danek USA, Inc. | 2012-05-30 |
| PROCARE PLUS VITRECTOMY SYSTEM (K120170) | Visioncare Devices, Inc. | 2012-05-30 |
| ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS (K120360) | Ortho Solutions Limited | 2012-05-29 |
| SI-FIX SACROILIAC JOINT FUSION SYSTEM (K110472) | Medtronic Sofamor Danek | 2012-05-29 |
| TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION (K113561) | Zimmer Trabecular Metal Technology | 2012-05-29 |
| UNIMED TEMPERATURE PROBE (K121427) | Unimed Medical Supplies, Inc. | 2012-05-29 |
| HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER (K111004) | Hansen Medical, Inc. | 2012-05-29 |
| PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY (K120333) | Gambro Renal Products | 2012-05-25 |
| AMT T-FASTENER ANCHOR KIT (K120587) | Applied Medical Technology, Inc. | 2012-05-25 |
| VPAP TX (K113714) | Resmed, Ltd. | 2012-05-25 |
| SHASER HRS2 HAIR REMOVAL SYSTEM (K120080) | Shaser, Inc. | 2012-05-25 |
| OPTOS ADVANCE (K113696) | Optos Plc. | 2012-05-25 |
| SYNTHES ACIS/VERTEBRAL SPACER CR (K120275) | Synthes (Usa), LLC | 2012-05-25 |
| HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD GLUCOSE SYSTEM (K110074) | Health & Life Co., Ltd. | 2012-05-25 |
| MOBILE VERSA LIGHT (K111049) | Medtek Lighting Corp | 2012-05-25 |
| CHOYANG THERMAL MASSAGER (K111941) | Choyang Medical Instrument Co., Ltd. | 2012-05-25 |
| I-FUSE HAMMER TOE SYSTEMS (K113006) | Orthopro, LLC | 2012-05-25 |
| RANGE SPINAL SYSTEM, UNIT ROD (K120899) | K2m, Inc. | 2012-05-25 |
| MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT (K120612) | Medtronic, Inc. | 2012-05-25 |
| UPSTREAM GR CATHETER (K120964) | Upstream Peripheral Technologies | 2012-05-25 |
| COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM (K121039) | Copan Flock Technologies | 2012-05-25 |
| SPIRTIUS CUFF INFLATION SYRINGE (K112915) | Spiritus Technologies, LLC | 2012-05-25 |
| PATIENT MONITOR (K120631) | Advanced Instruments, Inc. | 2012-05-25 |
| K-LASER (K120604) | Eltech S.R.L | 2012-05-25 |
| WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT (K121380) | Teleflexmedical, Inc. | 2012-05-25 |
| CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM (K112550) | Sebia | 2012-05-25 |
| VPAP ADAPT (K113801) | Resmed Corp | 2012-05-25 |
| PAX-DUO3D PLUS, PCT-5000 (K121236) | VATECH Co., Ltd. | 2012-05-24 |
| AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM (K120559) | Aesculap, Inc. | 2012-05-24 |
| SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 (K112491) | Sebia | 2012-05-24 |
| TOUAREG CLOSEFIT DENTAL IMPANT SYSTEM (K112585) | Adin Dental Implants System, Ltd. | 2012-05-24 |
| LEKSELL GAMMA KNIFE PERFEXION (K120811) | Elekta Instrument AB | 2012-05-24 |
| MAYFIELD SKULL CLAMP (K120633) | Integra LifeSciences Corporation | 2012-05-24 |
| PRAEZIS PLUS (K110644) | Tatramed Spol. S.R.O. | 2012-05-24 |
| COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM (K112905) | Biomet Orthopedics, LLC | 2012-05-24 |
| GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN (0.5 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-O (K120601) | Geistlich Pharma AG | 2012-05-24 |
| DUAL SPIKE TRANSFER DEVICE (K120150) | B.Braun Medical, Inc. | 2012-05-24 |
| ES BOND (K120767) | Spident Co., Ltd. | 2012-05-24 |
| RHEA CUP (K112165) | Apex Medical Technologies, Inc. | 2012-05-24 |
| PENTARAY NAV HIGH-DENSITY MAPPING CATHETER (K120425) | Biosense Webster, Inc. | 2012-05-24 |
| REMOTE PRESENCE SYSTEM (K120895) | Intouch Health, Inc. | 2012-05-24 |
| PRIMED TRACHEOSTOMY TUBES (MULTIPLE) (K120079) | Primed Halberstadt Medizintechnik GmbH | 2012-05-24 |
| LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM (K120840) | L&K BIOMED Co., Ltd. | 2012-05-24 |
| K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR (K121232) | Kamiya Biomedical Company | 2012-05-24 |
| VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER (K120118) | Ventlab Corp. | 2012-05-24 |
| CDC DENV-1-4 REAL TIME RT-PCT ASSAY (DEN120012) | Centers for Disease Control and Prevention | 2012-05-24 |
| MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE (K121239) | Optoacoustics, Ltd. | 2012-05-24 |
| SUNTOUCH TOPICAL HEMOSTATIC DRESSING (K112800) | Huizhou Foryou Medical Devices Co., Ltd. | 2012-05-23 |