| MICROSTREAM FILTERLINE ICU (K121927) | Oridion Medical 1987 , Ltd. | 2012-11-29 |
| TS FIXTURE SYSTEM (K121995) | Osstem Implant Co., Ltd. | 2012-11-29 |
| PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM (K123207) | Osteomed LP | 2012-11-29 |
| COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160 (K122722) | Roche Diagnostics | 2012-11-29 |
| CONSTRUX MINI PEEK TI SPACER SYSTEM (K121649) | Orthofix | 2012-11-29 |
| VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL (K122429) | Object Research Systems (Ors), Inc. | 2012-11-28 |
| CHECKMATE SMALL BONE FUSION SYSTEM (K122334) | Arthrosurface, Inc. | 2012-11-28 |
| BLIP MODEL BP-700WF (K123020) | Carematix, Inc. | 2012-11-28 |
| ILLICO FS FACET FIXATION SYSTEM (K123218) | Alphatec Spine, Inc. | 2012-11-28 |
| AZUR CX DETACHABLE 18 (K123384) | MicroVention, Inc. | 2012-11-28 |
| CERARESIN BOND (K123119) | Shofu Dental Corporation | 2012-11-28 |
| TXCELL SCANNING LASER DELIVERY SYSTEM (K121475) | Iridex Corp | 2012-11-28 |
| MINIFIX BALL MINIFIX ONE (K122052) | Bonafix Surgical and Dental Implants, LLC | 2012-11-28 |
| SEAL ONE (K123035) | Perouse Medical | 2012-11-28 |
| ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER (K121775) | Vital Signs, Inc., A GE Healthcare Company | 2012-11-28 |
| PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR (K122495) | Perkinelmer, Inc. | 2012-11-28 |
| DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA (K122420) | Diazyme Laboratories | 2012-11-28 |
| SJM CONFIRM (K122161) | St Jude Medical | 2012-11-28 |
| AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 (K122543) | MicroVention, Inc. | 2012-11-28 |
| ABBOTT ARCHITECT FREE T4 (K123379) | Abbott Laboratories | 2012-11-27 |
| ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN (K122561) | Ceremed , Inc. | 2012-11-27 |
| PICOSURE WORKSTATION (K121346) | Cynosure, Inc. | 2012-11-27 |
| OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC, (K121989) | Exactech, Inc. | 2012-11-27 |
| MULTICROSS SUPPORT CATHETER (K121763) | Roxwood Medical, Inc. | 2012-11-27 |
| MERETE LOCKING BONE PLATE SYSTEM III (K120787) | Merete Medical GmbH | 2012-11-27 |
| STABILIZ FIXATION SYSTEM (K120651) | Stabiliz Orthopaedics, LLC | 2012-11-27 |
| TANDA PEARL, ULTRAWYTE, PEARL (K122725) | Syneron Beauty | 2012-11-27 |
| WATER BOTTLE CAP IRRIGATON SYSTEM (K120862) | Endochoice, Inc. | 2012-11-27 |
| D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000 (K121093) | Dxm Co., Ltd. | 2012-11-27 |
| POLARIS DIAL-A-DATE CONTACT LENS CASE (K120904) | Reliance Design & Manufacture Corp. | 2012-11-26 |
| CUROS TIP (K121171) | Ivera Medical, Inc. | 2012-11-26 |
| KITAZATO OPU NEEDLE (K112462) | Kitazato Medical Co., Ltd. | 2012-11-26 |
| PICCOLO COMPOSITE PLATE SYSTEM (K120409) | CarboFix Orthopedics , Ltd. | 2012-11-26 |
| SENSUS ELECTRODE (K121816) | Neurometrix, Inc. | 2012-11-26 |
| DIOWAVE LOW LEVEL COLD LASER SYSTEM (K121363) | Technological Medical Advancments, Inc. (Tma) | 2012-11-23 |
| G7 ACETABULAR SYSTEM (K121874) | Biomet Manufacturing Corp | 2012-11-23 |
| MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254 (K122581) | Concentric Medical, Inc. | 2012-11-21 |
| POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES (K121811) | Shen Wei (Usa), Inc. | 2012-11-21 |
| VECTTOR VT-200 (K121662) | Alan Neuromedical Technologies, LLC | 2012-11-21 |
| HEMASORB APPLY (K121953) | Orthocon, Inc. | 2012-11-21 |
| POWERPLAY MUSCLE MASSAGER (K122154) | Fig, LLC | 2012-11-21 |
| STR GRAFT (K121216) | Soft Tissue Regeneration, Inc. | 2012-11-21 |
| SONICSTIMU COMBO THERAPEUTIC DEVICE (K120217) | Shenzhen Dongdixin Technology Co., Ltd. | 2012-11-21 |
| .DECIMAL PHOTON BLOCK (K123015) | .Decimal, Inc. | 2012-11-21 |
| AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE (K120326) | Radiometer Medical Aps | 2012-11-21 |
| PLANMED NUANCE DIGIGUIDE (K121963) | Planmed OY | 2012-11-21 |
| ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM (K122110) | ACON Laboratories, Inc. | 2012-11-21 |
| CORIN TRINITY-I ACETABULAR SHELL (K122305) | Corin USA | 2012-11-21 |
| THERMOFORMED MOUTHGUARDS (K121365) | Glidewell Laboratories-Sleep Devices Group | 2012-11-20 |
| 3M TRUE DEFINITION SCANNER (K122467) | 3M Company | 2012-11-20 |
| EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT (K121220) | Exactech, Inc. | 2012-11-20 |
| S-LOK PSS SYSTEM (K122931) | Spinal USA | 2012-11-20 |
| AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES (K122488) | Catheter Robotics, Inc. | 2012-11-20 |
| AHIP INTERNAL TRIGGER POINT WAND MODEL: 1 (DEN100023) | National Center For Pelvic Pain Research Devices, | 2012-11-20 |
| ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS (K122596) | Smith & Nephew, Inc. | 2012-11-20 |
| PHT-6500; PHT-60CFO; PAX-I3D (K122606) | Mtechgroup | 2012-11-20 |
| CDI BLOOD PARAMETER MONITORING SYSTEM 500 (K123039) | Terumo Cardiovascular Systems Corp. | 2012-11-20 |
| SYNGO.VIA (K123375) | Siemens AG | 2012-11-20 |
| HET BIPOLAR LIGATOR SYSTEM (K121085) | Het Systems, LLC | 2012-11-20 |
| FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM (K121499) | Fujifilm Medical System U.S.A., Inc. | 2012-11-20 |
| PENUMBRA DDC CATHETERS (K122772) | Penumbra, Inc. | 2012-11-20 |
| QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN (K123409) | Surgical Specialties Corp. Dba Angiotech | 2012-11-20 |
| COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM (K123297) | Biomet Manufactuting Corp. | 2012-11-20 |
| HEALTHMATEFOREVER (K121757) | Healthmate International, LLC | 2012-11-20 |
| CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE (K121846) | B.Braun Medical, Inc. | 2012-11-20 |
| ZOLL RESCUENET 12-LEAD (K121865) | ZOLL Medical Corporation | 2012-11-20 |
| UFIT TEN-10 (K122443) | Biosign Technologies, Inc. | 2012-11-20 |
| PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM (K121977) | Plasma Surgical Limited | 2012-11-20 |
| REMOTE PRESENCE SYSTEM, MODEL RP-VITA (K123229) | Intouch Health, Inc. | 2012-11-20 |
| VICEROY SPINAL SYSTEM (K122229) | Torrey Spine | 2012-11-20 |
| HI-TORQUE COMMAND GUIDE WIRE FAMILY (K122573) | Abbott Vascular, Inc. | 2012-11-20 |
| FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION (K122454) | Fujifilm Medical System U.S.A., Inc. | 2012-11-20 |
| GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING (K121234) | W. L. Gore & Associates, Inc. | 2012-11-20 |
| RUMBLE TUFF (K113315) | Acute Ideas Co. , Ltd. | 2012-11-20 |
| RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3 (K121603) | Randox Laboratories, Ltd. | 2012-11-20 |
| LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA (K123198) | Bio-Rad Laboratories | 2012-11-20 |
| VITEK 2 GRAM NEGATIVE DOXYCYCLINE (K121546) | bioMerieux, Inc. | 2012-11-20 |
| AIRSTRIP RPM FOR LIFENET CONSULT (K121712) | Airstrip Technologies, Inc. | 2012-11-20 |
| SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM (K113567) | Synthes, Inc. | 2012-11-19 |
| ZOU ANTERIOR LUMBAR PLATE SYSTEM (K121791) | Corelink, LLC | 2012-11-19 |
| NON-CONTACT THERMOMETER (K120711) | K-Jump Health Co., Ltd. | 2012-11-19 |
| ACUMED PELVIC BONE PLATE SYSTEM (K122538) | Acumed, LLC | 2012-11-19 |
| RESTORELLE L (K122440) | Coloplast Corp. | 2012-11-19 |
| SENTRYSUITE PRODUCT LINE (K122699) | Carefusion Germany 234 GmbH | 2012-11-19 |
| VITEK 2 AST STREPTOCOCUS VANCOMYCIN (K121100) | bioMerieux, Inc. | 2012-11-19 |
| LOQTEQ DISTAL LATERAL FEMUR PLATE 4.5 (LEFT AND RIGHT VERSION) LOQREQ CORTICAL SCREW 4.5 T25, SELF-TAPPING (K121494) | Aap Implantate AG | 2012-11-19 |
| PTFE SUPER SHEATH INTRODUCER (K120617) | Martech Medical Products | 2012-11-19 |
| ALIVECOR HEART MONITOR FOR IPHONE (K122356) | AliveCor, Inc. | 2012-11-19 |
| MOBILECARE MONITOR (K122333) | Aframe Digital, Inc. | 2012-11-19 |
| CD HORIZON SPIRE Z SPINAL SYSTEM (K123246) | Medtronic Sofamor Danek | 2012-11-16 |
| ACCU-CHEK ULTRAFLEX INFUSION SET (K122686) | Roche Diabetes Care AG | 2012-11-16 |
| PRO-LINK CERVICAL SPACER SYSTEM (K121151) | Life Spine, Inc. | 2012-11-16 |
| ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACE (K122529) | Zimmer, Inc. | 2012-11-16 |
| PEDIATRIC POSITIONER PAD SET (K122174) | Ge Healthcare Coils (Usa Instruments, Inc.) | 2012-11-16 |
| CENTRICITY PACS-IW WITH UNIVERSAL VIEWER (K123174) | GE Healthcare | 2012-11-16 |
| ENDOSSEOUS DENTAL IMPLANT (K113113) | Ot Medical GmbH | 2012-11-16 |
| POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL (K120066) | Kossan Latex Industries(M)Sdn Bhd | 2012-11-16 |
| HAMILTON-C2 (K121225) | Hamilton Medical AG | 2012-11-16 |
| ABL90 FLEX (K122729) | Radiometer Medical Aps | 2012-11-16 |
| TEXTURED, BLUE, LATEX, POWDER FREE EXAMINATION GLVOES, WITH PROTEIN LABELING CLAIM (50UG/DM OR LESS OF WATER SOLUBLE PRO (K123026) | Northstar Healthcare Holdings | 2012-11-16 |