| SAFETY SUBCUTANEOUS TISSUE INFUSION SET (K120195) | Multi Med | 2012-07-06 |
| SUNFLOWER WARNER (K120937) | Atom Medical Corporation | 2012-07-06 |
| AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM (K120649) | Apex BioTechnology Corp. | 2012-07-06 |
| VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM (K121096) | L&K BIOMED Co., Ltd. | 2012-07-06 |
| FLIGHT 60 VENTILATOR (K120726) | Flight Medical Innovations , Ltd. | 2012-07-06 |
| MECHANICAL WHEELCHAIR (K120302) | Novaf Andalucia 2007, SL | 2012-07-06 |
| SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE (K121601) | Synthes USA | 2012-07-06 |
| HEATLUX (K120582) | Home Skinovations , Ltd. | 2012-07-06 |
| SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE (K121030) | Sacks Holdings, Inc. | 2012-07-06 |
| NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTOR (K120468) | Cook Incorporated | 2012-07-06 |
| FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM (K121125) | Flexible Stenting Solutions, Inc. | 2012-07-06 |
| BIOPURE PORTABLE RO SYSTEMS (K112331) | Arion Water, Inc. | 2012-07-05 |
| BD MAX MRSA ASSAY, BD MAX INSTRUMENT (K120138) | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 2012-07-05 |
| BLUE POWER FREE NITRILE EXAMINATION GLOVE (K121464) | Northstar Healthcare Holdings | 2012-07-05 |
| ACCULIF TL CAGE (K121683) | Coalign Innovations, Inc. | 2012-07-05 |
| SYNAPSE 3D CARDIAC TOOLS (K120636) | Fujifilm Medical System U.S.A., Inc. | 2012-07-05 |
| SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR (K120244) | Nexera Medical, Inc. | 2012-07-05 |
| AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEM (K120739) | Tornier, Inc. | 2012-07-05 |
| ILUMINAGE DIODE LASER (K111454) | Cynosure, Inc. | 2012-07-05 |
| CD HORIZON SPINAL SYSTEM (K121680) | Medtronic Sofamor Danek USA, Inc. | 2012-07-05 |
| DENTIN DENTAL IMPLANTS SYSTEM: RAPID, CLASSIC, PRESTIGE, ONE PIECE, DENTIN DENTAL ABUTMENT SYSTEM / DENTIN RESTORATION S (K120530) | Dentin Implants Technologies , Ltd. | 2012-07-05 |
| CARDIOPACS (K120514) | Lumedx | 2012-07-05 |
| SIMPLANT GO (K120733) | Materialise Dental NV | 2012-07-05 |
| ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA (K120338) | Astra Tech, Inc. | 2012-07-05 |
| ORANGE COLORED CONDOMS ORANGE SCENT (K113056) | Karex Industries Sdn. Bhd. | 2012-07-03 |
| FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R) (K121107) | Globus Medical, Inc. | 2012-07-03 |
| CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM (K120941) | Constant Care, LLC | 2012-07-03 |
| AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING (K121871) | Airstrip Technologies, LP | 2012-07-03 |
| COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT PLATIUM VENA CAVA FILTER SET FOR JUGULAR APPR (K121629) | William Cook Europe Aps | 2012-07-03 |
| MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000 (K121336) | Surgiquest, Inc. | 2012-07-03 |
| TRINON Q & Q3 IMPLANT SYSTEM (K103577) | Trinon Titanium GmbH | 2012-07-03 |
| DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL (K121122) | Biochemical Diagnostic, Inc. | 2012-07-03 |
| SPINAL ELEMENTS CERCLAGE SYSTEM (K120177) | Spinal Elements, Inc. | 2012-07-03 |
| U-RIGHT TD-3124 BLOOD PRESSURE MONITORING SYSTEM (K120634) | Taidoc Technology Corporation | 2012-07-03 |
| WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS) (K121669) | Cincinnati Sub-Zero Products, Inc. | 2012-07-03 |
| SPINE FRONTIER INDUS ACP SYSTEM (K121060) | Spinefrontier, Inc. | 2012-07-03 |
| PERICAM PSI (K120884) | Perimed AB | 2012-07-03 |
| DEPUY PULSE LUMBAR CAGE SYSTEM (K120966) | Medos International SARL | 2012-07-03 |
| UTB BLUE POWDER FREE NITRILE (K121506) | Northstar Healthcare Holdings | 2012-07-03 |
| NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP (K112634) | Inotec Amd , Ltd. | 2012-07-03 |
| ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT (K113262) | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-07-03 |
| ASTHMAPOLIS SYSTEM (K121609) | Reciprocal Labs Corporation | 2012-07-02 |
| ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY (K121448) | Elekta Inc. D/B/A Nucletron Corporation | 2012-07-02 |
| ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT (K113435) | Alfa Wassermann | 2012-07-02 |
| K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER (K120285) | Curative Medical, Inc. | 2012-07-02 |
| WAVE O CAGE (K121330) | Advanced Medical Technologies AG | 2012-06-29 |
| STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO (K120459) | Oscor, Inc. | 2012-06-29 |
| PROGRIP LAPARSCOPIC SELF-FIXATING MESH (K120897) | Sofradim Production | 2012-06-29 |
| AC WOUND TREATMENT SYSTEM (K111949) | Nanovibronix, Inc. | 2012-06-29 |
| BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEM (K113512) | Biomet Microfixation | 2012-06-29 |
| TEK USA E-GENERATOR INTEGRATED LED HANDPIECE (HIGH & LOW SPEED AIR TURBNINE DENTAL HANDPIECE) (K120218) | Palm Beach Dental Supply D/B/A Tek USA | 2012-06-29 |
| FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM (K121175) | Ostial Corporation | 2012-06-29 |
| FUSE CAGE (K121288) | Advanced Medical Technologies AG | 2012-06-29 |
| TUBALGATOR (K113080) | Mectra Labs, Inc. | 2012-06-29 |
| VERTEX RCCONSTRUCTION SYSTEM (K121191) | Medtronic Sofamor Danek, Inc. | 2012-06-29 |
| EXACTRAC ROBOTICS NOVALIS ROBOTICS (K120520) | Brainlab AG | 2012-06-29 |
| MOUNTED MEDICAL OXYGEN SYSTEM (K113767) | Essex Industries, Inc. | 2012-06-29 |
| ICTA (K120260) | Excel-Tech Ltd. (Xltek) | 2012-06-29 |
| NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL (K120990) | Zimmer Trabecular Metal Technology | 2012-06-29 |
| ARCHSTENT BILIARY SYSTEM (K113582) | Ostial Corporation | 2012-06-29 |
| ANY VIEW PATIENT MONITORS (K120193) | Guangdong Biolight Meditech Co., Ltd. | 2012-06-29 |
| FREEDOM(R) STEMMED TIBIAL COMPONENTS (K111785) | Maxx Orthopedics, Inc. | 2012-06-29 |
| SC TIP CLEANER (K120581) | Nsi | 2012-06-29 |
| FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MM (K113775) | Ostial Corporation | 2012-06-29 |
| INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR (K121634) | Baxter Healthcare Corporation | 2012-06-29 |
| SYSTEMS INTEGRATION (K121701) | Olympus Medical Systems Corp. | 2012-06-29 |
| ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA ANTEGRADE CATHETER WITH DURAFLO COATING (K113459) | Edwards Lifesciences, LLC | 2012-06-29 |
| INTELLISPACE ECG (K120855) | Philips Health Care | 2012-06-29 |
| POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES (K120963) | Medtexx Manufacturing Sdn. Bhd. | 2012-06-29 |
| VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM (K113200) | bioMerieux, Inc. | 2012-06-29 |
| LOOP CAGE (K121332) | Advanced Medical Technologies AG | 2012-06-29 |
| FLOWEASE [SUBCUTANEOUS] INFUSION SET (K121092) | Baxter Healthcare Corp | 2012-06-29 |
| SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM (K121574) | Synthes, Inc. | 2012-06-29 |
| WAVE D CAGE (K121333) | Advanced Medical Technologies AG | 2012-06-29 |
| CLEARPATH 24 (K112318) | Promedic, Inc. | 2012-06-29 |
| MED-RX PATIENT DELIVERY SET (K120375) | Benlan, Inc. | 2012-06-28 |
| CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM (K103467) | KARL STORZ Endoscopy-America, Inc. | 2012-06-28 |
| CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM (K121087) | Bayer Healthcare | 2012-06-28 |
| FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN (K120996) | Paragon Vision Sciences | 2012-06-28 |
| WI-FI BODY SCALE (K121527) | Shenzhen Healthcare Electronic Technology Co., Ltd. | 2012-06-28 |
| SONY PVM-2551MD OLED MONITOR (K120611) | Sony Electronics, Inc. | 2012-06-28 |
| ARCHITECT HAVAB-G (K113704) | Abbott Laboratories | 2012-06-28 |
| FIBEROPTIC LASER DELIVERY SYSTEM (K120810) | Fiberoptic Fabrications, Inc. | 2012-06-28 |
| NUVASIVE COROENT TITANIUM SYSTEM (K120918) | Nuvasive, Inc. | 2012-06-28 |
| POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC) (K121522) | Polyremedy, Inc. | 2012-06-27 |
| DR GREENBURGS HYBRID VACUUM (K120372) | Always More Marketing, Inc. | 2012-06-27 |
| DATACAPTOR SYSTEM (K113835) | Capsule Tech, Inc. | 2012-06-27 |
| ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD (K113326) | Oralabs, Inc. | 2012-06-27 |
| ARTISTETM SOLUTION WITH SYS VCIO (K121295) | Siemens Medical Solutions USA, Inc. | 2012-06-27 |
| EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE (K120780) | Edwards Lifesciences, LLC | 2012-06-27 |
| RANGE SPINAL SYSTEM (MESA AND DENALI) (K121016) | K2m, Inc. | 2012-06-27 |
| GAM-200 (K120243) | GC America, Inc. | 2012-06-27 |
| DR GREENBURGS HYBRID ACRYLIC (K120371) | Always More Marketing, Inc. | 2012-06-27 |
| LDR SPINE SPINETUNE TL SPINAL SYSTEM (K120760) | Ldr Spine USA, Inc. | 2012-06-27 |
| UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM (K121049) | Globus Medical, Inc. | 2012-06-27 |
| VU APOD INTERVERTEBRAL BODY FUSION DEVICE (K121211) | Theken Spine, LLC | 2012-06-27 |
| PIXEL APP (K121274) | Gauss Surgical, Inc., | 2012-06-27 |
| NEXT GEN EMG ENDOTRACHEAL TUBE (K112686) | Medtronic Xomed, Inc. | 2012-06-27 |
| VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) (DEN120014) | Nanosphere, Inc. | 2012-06-26 |
| ENSPIRE DISCECTOMY SYSTEM (K120680) | Spine View, Inc. | 2012-06-26 |