| OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES (K103161) | Omega Laboratories, Inc. | 2011-12-13 |
| GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM (K113034) | GE Healthcare | 2011-12-13 |
| VBB SYSTEM (K110604) | Synthes | 2011-12-13 |
| INFRASCANNER, MODEL 1000 (DEN100002) | Infrascan, Inc. | 2011-12-13 |
| TARGET DETACHABLE COIL (K113412) | Stryker Neurovascular | 2011-12-13 |
| SYNTHES HEMOSTATIC BONE PUTTY (K113079) | Synthes (Usa) Products, LLC/Norian Corporation | 2011-12-13 |
| STAXX(R) XD SYSTEM (K111418) | Spine Wave, Inc. | 2011-12-13 |
| INTERFACE BONE VOID FILLER (K112857) | Biostructures, LLC | 2011-12-13 |
| ACCULIF TL CAGE (K113465) | Coalign Innovations, Inc. | 2011-12-12 |
| CELLTRACKS ANALYER II (K113181) | Veridex, LLC | 2011-12-12 |
| SYNTHES ZERO-P (K112459) | Synthes Spine Co.Lp | 2011-12-12 |
| OSTEOSPRING FOOTJACK SUBTALAR IMPLANT SYSTEM (K112658) | Osteospring Medical, Inc. | 2011-12-12 |
| SPACER-S (K112983) | Tecres S.P.A. | 2011-12-12 |
| XINGTM SPINE SYSTEM (K111995) | Implanova Co., Ltd. | 2011-12-12 |
| ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING (K113102) | Nucletron | 2011-12-12 |
| ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM (K102425) | Zeus Scientific, Inc. | 2011-12-12 |
| ARROW-LOK DIGITAL SYSTEM (K112675) | Arrowhead Medical Device Technologies, LLC | 2011-12-12 |
| ORTHOLOC 3DSI LOCKING SCREWS (K113339) | Wrightmedicaltechnologyinc | 2011-12-12 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MO (K111830) | Andon Health Co, Ltd. | 2011-12-09 |
| ATB ADVANCE PTA DILATATION CATHETER (K113300) | Cook, Inc. | 2011-12-09 |
| ACTIV VARNISH (K112946) | Pulpdent Corporation | 2011-12-09 |
| OSLEOBRIDGE IDSF SPACER CONECTOR (K113303) | Merete Medical GmbH | 2011-12-09 |
| SARN CENTRIFUGAL PUMP (K112229) | Terumo Cardiovascular Systems | 2011-12-09 |
| CANADY VIEIRA HYBRID PLASMA SCALPEL (K113500) | Us Medical Innovations, LLC | 2011-12-09 |
| GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM (K111132) | Genesys Spine | 2011-12-09 |
| EVOLUTION MP ADAPTIVE CS INSERT (K113325) | Wrightmedicaltechnologyinc | 2011-12-09 |
| THE BUZZ FACIAL TONING SYSTEM (K102494) | Daka International , Ltd. | 2011-12-09 |
| RENOVIS CANNULATED SCREW SYSTEM (K113084) | Renovis Surgical Technologies, LLC | 2011-12-09 |
| NETKONNECT REMOTE NETWORK EXTENSION (K112637) | Nihon Kohden | 2011-12-09 |
| SI-LOK SACROILIAC JOINT FIXATION SYSTEM (K112028) | Globus Medical, Inc. | 2011-12-09 |
| EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER (K112513) | Natec Medical , Ltd. | 2011-12-09 |
| PRESAGE ST2 ASSAY (K111452) | Critical Care Diagnostics, Inc. (Dba Critical Diag | 2011-12-09 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K111826) | Andon Health Co, Ltd. | 2011-12-09 |
| BONE PLATE; BONE SCREW (K110926) | Biomaterials Korea, Inc. | 2011-12-08 |
| ZAVATION CERVICAL PLATE SYSTEM (K112533) | Zavation, LLC | 2011-12-08 |
| SHIELD KYPHOPLASTY SYSTEM (K093477) | Soteira, Inc. | 2011-12-08 |
| SPLIT CATH III (K111651) | Medical Components, Inc. | 2011-12-08 |
| BRUX MOUTHGUARDS (K111310) | Dental Arte, Inc. | 2011-12-08 |
| CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER (K112093) | Keeler Instruments, Inc. | 2011-12-08 |
| CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION (K113111) | Inovo, Inc. | 2011-12-08 |
| MODEL PM3030 (K110068) | Omron Healthcare, Inc. | 2011-12-08 |
| VARILIFT CERVICAL INTERBODY FUSION SYSTEM (K111123) | Wenzel Spine | 2011-12-08 |
| ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR (K111646) | Fujifilm Medical System U.S.A., Inc. | 2011-12-08 |
| ANGLED TAPERED ABUTMENT (K111853) | Zimmer Dental, Inc. | 2011-12-08 |
| PRESSON ELECTRODE (K103103) | Persyst Development Corp. | 2011-12-08 |
| AIR-N-GO (K110379) | Satelec | 2011-12-08 |
| NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER (K113227) | Baxter Healthcare Corp | 2011-12-08 |
| EXACTECH EQUINOXE CAGE GLENOIDS (K113309) | Exactech, Inc. | 2011-12-08 |
| MODIFIED ROG SUTURE ANCHOR (K112991) | Rog Sports Medicine, Inc. | 2011-12-08 |
| AQUA LUBE (K110325) | Mayer Laboratories, Inc. | 2011-12-08 |
| INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES (K112208) | Intuitive Surgical, Inc. | 2011-12-08 |
| TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES (K111736) | Tuttnauer Co. , Ltd. | 2011-12-08 |
| 3M TEGADERM MATRIX DRESSING (K110457) | 3M Company | 2011-12-07 |
| ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM (K113179) | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2011-12-07 |
| ATHENA PEDICLE SCREW SYSTEM (K110046) | Royal Oak Medical Devices | 2011-12-07 |
| SWIFT FX BELLA (K112489) | Resmed, Ltd. | 2011-12-07 |
| SEITY 37% PHOSPHORIC ACID ETCHANT GEL (K112597) | Mycone Dental Supply Co., Inc. | 2011-12-07 |
| DSJ MASSAGER (K112479) | Mego Afek AC , Ltd. | 2011-12-07 |
| JOULE CLEARSENSE LASER SYSTEM (K111483) | Sciton, Inc | 2011-12-07 |
| EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER (K113182) | Edwards Lifesciences, LLC | 2011-12-07 |
| DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS (K110924) | Synergetics, Inc. | 2011-12-07 |
| DORNIER MEDILAS D LITEBEAM+ 1470 (K110364) | Dornier Medtech America, Inc. | 2011-12-07 |
| NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREE (K110698) | Terang Nusa Sdn Bhd | 2011-12-07 |
| LARGE/EXTRA LAGRE CONDOM (K113061) | Karex Industries Sdn. Bhd. | 2011-12-07 |
| IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D (K103544) | Agamatrix, Inc. | 2011-12-07 |
| ASCENSION ATLAS HUMERAL PLATING SYSTEM (K110700) | Ascension Orthopedics, Inc. | 2011-12-06 |
| ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT (K111889) | Zimmer Dental, Inc. | 2011-12-06 |
| INFRARED EAR THERMOMETER (K111637) | Radiant Innovation, Inc. | 2011-12-06 |
| SPARTAN S3 FACET SYSTEM (K113011) | Amendia, Inc. | 2011-12-06 |
| NOVAPORT ONE VASCULAR ACCESS CANNULA (K112565) | Novalung GmbH | 2011-12-06 |
| PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL (K111363) | Medica Corp. | 2011-12-06 |
| H-WAVE (K112485) | Electronic Waveform Lab, Inc. | 2011-12-06 |
| DISCO SUBTALAR IMPLANT (K111834) | Trilliant Surgical, Ltd. | 2011-12-06 |
| DENTAL 3D PLANNING SOFTWARE (K113404) | Symbyo Dental, LLC | 2011-12-06 |
| MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR (K112845) | Microlife Intellectual Property GmbH | 2011-12-05 |
| SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS (K111667) | Synthes (Usa) | 2011-12-05 |
| BENDINI(TM) SPINAL ROD BENDING SYSTEM (K111811) | Nuvasive, Inc. | 2011-12-05 |
| BRIVO NM 615 (K113350) | GE Healthcare | 2011-12-05 |
| EYE CARE CURE CONTACT LENS CASE (K112832) | Eye Care and Cure | 2011-12-05 |
| LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2 (K113213) | Biosense Webster, Inc. | 2011-12-05 |
| ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT (K112125) | Meridian Bioscience, Inc. | 2011-12-05 |
| AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP) (K113501) | Ameditech, Inc. | 2011-12-05 |
| AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER (K111732) | Salient Surgical Technologies, Inc. | 2011-12-05 |
| SYNTHES CORTICAL SCREWS (K112583) | Synthes (USA) Products, LLC | 2011-12-05 |
| AXLE PEEK INTERSPINOUS FUSION SYSTEM (K112592) | X-Spine Systems, Inc. | 2011-12-05 |
| SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS) (K112610) | Inpro Technology Device Factory | 2011-12-05 |
| MOBILE MIM (K112930) | Mim Software, Inc. | 2011-12-02 |
| IMMULISA SCI-70 ANTIBODY ELISA (K113143) | Immco Diagnostics, Inc. | 2011-12-02 |
| VOCARE MYHEALTH TABLET (K111922) | Vocare, Inc. | 2011-12-02 |
| BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC (K113267) | CooperVision, Inc. | 2011-12-02 |
| APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM) (K112779) | Omnlife Science | 2011-12-02 |
| PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS (K113235) | Medtronic, Inc. | 2011-12-02 |
| WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE (K110615) | Bebe Toys Manufactory , Ltd. | 2011-12-02 |
| ESENSOR WARFARIN SENSITIVITY SALIVA TEST (K110786) | GenMark Diagnostics, Inc. | 2011-12-02 |
| MAGNESIUM ASSAY (K111915) | Sekisui Diagnostics P.E.I., Inc. | 2011-12-02 |
| MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM (K112559) | Medapps, Inc. | 2011-12-02 |
| ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 (K110701) | DNA Genotek, Inc. | 2011-12-02 |
| VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS (K111751) | ETHICON, Inc. | 2011-12-02 |
| ANGIOJET ULTRA DVX THROMBECTOMY SET (K113428) | Medrad, Inc. | 2011-12-02 |
| AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL (K113245) | CooperVision, Inc. | 2011-12-02 |