| ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT) (K103474) | Micerium S.P.A. | 2011-02-07 |
| NAVIGATION MARKER, REFLECTIVE MARKER SPHERES (K103192) | Ilumark GmbH | 2011-02-07 |
| PERIOPATCH (K103054) | Izun Pharmaceuticals Corporation | 2011-02-07 |
| COROENT INTERLOCK SYSTEM (K102547) | Nuvasive, Inc. | 2011-02-07 |
| MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT (K082254) | Bodystat , Ltd. | 2011-02-07 |
| MEDEOR MATRIX (K103787) | Kensey Nash Corp. | 2011-02-07 |
| LUGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER (K102470) | Covidien, Formerly Valleylab, | 2011-02-07 |
| SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 (K103373) | Beckman Coulter, Inc. | 2011-02-07 |
| QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT (K082255) | Bodystat , Ltd. | 2011-02-07 |
| 5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL (K110164) | Arthrocare Corp. | 2011-02-07 |
| VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTE (K103173) | Orthovita, Inc. | 2011-02-07 |
| BAM STANDARD SURGICAL GOWN, BAM REINFORCED SURGICAL GOWN, BAM ULTRA REINFORCED SURGICAL GOWN (K093835) | Bam Corp., Ltd. | 2011-02-04 |
| AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0 (K103516) | Inovise Medical, Inc. | 2011-02-04 |
| SPY INTRA-OPERATIVE IMAGING SYSTEM (K100371) | Novadaq Technologies, Inc. | 2011-02-04 |
| DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100 (K101077) | Intuitive Surgical, Inc. | 2011-02-04 |
| STEREOS WORKSTATION (K101398) | Biospace Med | 2011-02-04 |
| 5MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319 (K101743) | Intuitive Surgical, Inc. | 2011-02-04 |
| MOBILE MIM (K103785) | Mim Software, Inc. | 2011-02-04 |
| URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10 (K101673) | Teco Diagnostics | 2011-02-04 |
| VECTEC DISPOSABLE MONOPOLAR CONNECTOR CABLE (K103707) | Vectec | 2011-02-04 |
| ACIES (K101842) | Konica Minolta Medical & Graphic, Inc. | 2011-02-04 |
| NUVUE COLORMARK9TM) NEEDLE (K101312) | Nuvue Therapeutics, Inc. | 2011-02-04 |
| GOLDEN GATE ANTERIOR PLATE SYSTEM (K101353) | Ulrich GmbH & Co. KG | 2011-02-04 |
| SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR (K103732) | Spacelabs Healthcare, Ltd. | 2011-02-04 |
| TURBO TEMP 3 (K102753) | Danville Materials, Inc. | 2011-02-04 |
| MULTICONSTITUENT CALIBRATOR (K103403) | Abbott Laboratories | 2011-02-04 |
| BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM (K110104) | Cincinnati Sub-Zero Products, Inc. | 2011-02-04 |
| COHESION BONE CEMENT (K103816) | Teknimed Sas | 2011-02-04 |
| FETAL DOPPLER JPD-100S (K110124) | Shenzhen Jumper Medical Equipment Co., Ltd. | 2011-02-04 |
| NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D (K101392) | Astoria-Pacific, Inc. | 2011-02-04 |
| MH1 MICROHOLTER RECORDER (K101969) | Exelys, LLC | 2011-02-04 |
| MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS (K103561) | Menicon Co, Ltd. | 2011-02-03 |
| INTERFUSE DA INVERTEBRAL BODY FUSION DEVICE (K110045) | Vertebral Technologies, Inc. | 2011-02-03 |
| NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED SURGICAL GOWNS (K102652) | Gri Medical & Electronic Technology Co., Ltd. | 2011-02-03 |
| PATIENT EXAMINATION GLOVES (K102838) | Thai Hua Holding Co., Ltd. | 2011-02-03 |
| SUTRAZORB (K102592) | Visionary Medical Supplies, Inc. | 2011-02-03 |
| BALL ABUTMENT SYSTEM (K101890) | Megagen Co., Ltd. | 2011-02-03 |
| FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR (K070049) | Fresenius Medical Care North America | 2011-02-03 |
| ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS (K102892) | Aqua Sciences, Inc. | 2011-02-03 |
| OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS (K103309) | Smith & Nephew Endoscopy, Inc. | 2011-02-03 |
| BUTLER CALCI-FLOR PROPHYLAXIS PASTE (K102053) | Sunstar Americas, Inc. | 2011-02-03 |
| MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT (K103233) | Howmedica Osteonics Corp. | 2011-02-03 |
| ATLANTIS ABUTMENT FOR KEYSTONE IMPLANT, ATLANTIS GEMINI ABUTMENT (K103020) | Atlantis Components, Inc. | 2011-02-03 |
| MONICA AN24 (K101801) | Monica Healthcare | 2011-02-03 |
| PET-512MC TRANSESOPHAGEAL TRANSDUCER (K103629) | Toshiba America Medical Systems, In.C | 2011-02-02 |
| POLARIS SPINAL SYSTEM (K103393) | Biomet Spine | 2011-02-02 |
| VASCULAIRE COMPRESSION SYSTEM (K103113) | Venous Health Systems, Inc. | 2011-02-02 |
| PEDIACYN ATOPIC DERMATITIS HYDROGEL (K102945) | Oculus Innovative Sciences, Inc. | 2011-02-02 |
| PROFIL COMPOSITES (PROFIL, PROFIL FLOW) (K103190) | Silmet , Ltd. | 2011-02-02 |
| SURGIAID (K100927) | Maxigen Biotech, Inc. | 2011-02-02 |
| ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE (K110009) | Cook, Inc. | 2011-02-02 |
| ARSTASIS ONE LATCHWIRE ACCESS SYSTEM (K103143) | Arstasis, Inc. | 2011-02-02 |
| ULTICARE SAFETY INSULIN SYRINGE (K103011) | Ulti-Med Intl., Inc. | 2011-02-02 |
| SIGNATURE PLANNER; SIGNATURE GUIDES (K102795) | Materialise NV | 2011-02-02 |
| 1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300) (K103506) | Imris, Inc. | 2011-02-02 |
| NASAL CEASE (K102742) | Catalina, Inc. | 2011-02-02 |
| SECURVIEW DX DIAGNOSTIC WORKSTATION (K103385) | Hologic, Inc. | 2011-02-02 |
| CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES (K103347) | Intervascular Sas | 2011-02-02 |
| TALON SPINAL SYSTEM (K102995) | Spine360 | 2011-02-02 |
| MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL (K103387) | ACON Laboratories, Inc. | 2011-02-02 |
| FINESS ENDOSCOPE STERILIZATION TRAY (K103213) | Entellus Medical, Inc. | 2011-02-02 |
| HYPO CLENZ WOUND WASH MODEL 100 PPM (K100948) | Nevoa Life Sciences, LLC | 2011-02-02 |
| ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETER (K102238) | Teleflexmedical, Inc. | 2011-02-01 |
| VISULAS TRION LASER SYSTEM WITH THE VITE OPTION (K103056) | Carl Zeiss Meditec, AG | 2011-02-01 |
| COR ANALYZER (K110071) | Rcadia Medical Imaging , Ltd. | 2011-01-31 |
| DEKA SYNCHRO FT (K103288) | El.En Electronic Engineering Spa | 2011-01-31 |
| M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM (K103677) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2011-01-31 |
| AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM (K102924) | Tornier, Inc. | 2011-01-31 |
| SYNAPSE 3D CARDIAC TOOLS (K103465) | Fujifilm Medical Systems U.S.A, Inc. | 2011-01-31 |
| PICCOLO COMPOSITE NAILING SYSTEM (K102369) | N.M.B. Medical Applications, Ltd. | 2011-01-31 |
| SMITH & NEPHEW SMF HIP STEM (K103256) | Smith & Nephew, Inc. | 2011-01-31 |
| REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM (K103208) | Encore Medical L.P. | 2011-01-31 |
| PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE (K103254) | Coloplast A/S | 2011-01-31 |
| MIRADRY SYSTEM (K103014) | Miramar Labs, Inc. | 2011-01-28 |
| SOLSTICE (K102621) | Kerr Corporation | 2011-01-28 |
| LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES, (K101263) | Lima-Lto S.P.A. | 2011-01-28 |
| STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR (K102884) | Advanced Sterilization Products | 2011-01-28 |
| FISIO CHAMBER SPACE (K101136) | Koo (Shanghai) Industries Co., Ltd. | 2011-01-28 |
| SENTICARE PILLSTATION (K103009) | Senticare, Inc. | 2011-01-28 |
| AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC (K102824) | Ambu A/S | 2011-01-28 |
| ANS SYSTEM (K101016) | Caird Technology | 2011-01-28 |
| NEUCOLONCARE (K110077) | Neusoft Medical Systems Co., Ltd. | 2011-01-28 |
| HEMA SCREEN ER (K102664) | Immunostics Inc., | 2011-01-28 |
| MAMMAPRINT (K101454) | Agendia | 2011-01-28 |
| COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL WIC-2008 (K102319) | Won Industrial Co. | 2011-01-28 |
| GC ORAL MOISTURIZING GEL (K101346) | GC America, Inc. | 2011-01-27 |
| OSTEORAPTOR II SUTURE ANCHOR OR TO BE DETERMINED MODEL: 72202764 72202765 72202766 72202767 72202768 72202769 72202770 (K101459) | Smith & Nephew, Inc. | 2011-01-27 |
| FLUID FILLED TEETHER - GEL (K092025) | Kids II | 2011-01-27 |
| 4D MV-ASSESSMENT 2.0 (K103782) | Tomtec Imaging Systems GmbH | 2011-01-27 |
| VENTLAB 6000 SERIES HUMIDIFIER (K093617) | Ventlab Corp. | 2011-01-27 |
| SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-1004 (K102363) | Spsmedical Supply Corp. | 2011-01-27 |
| REDONDO-L (K103297) | Seaspine, Inc. | 2011-01-27 |
| NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY (K102722) | Synthes USA Products, LLC | 2011-01-27 |
| TRIPLEPLAY-VT VASCULAR THERAPY SYSTEM (K103187) | Wildcat Medical, Inc. | 2011-01-26 |
| BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED EAR THERMOMETERS (K103800) | Kaz USA, Inc (A Subsidiaryof Kaz Inc) | 2011-01-26 |
| DISPOSABLE BLOOD PRESSURE CUF (K102792) | Caremate Medical Device Co., Ltd. | 2011-01-26 |
| ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE (K110004) | Advanced Surgical Concepts | 2011-01-26 |
| FREQUENCER (K103176) | Dymedso, Inc. | 2011-01-26 |
| MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO (K103780) | Micrus Endovascular Corporation | 2011-01-26 |
| CD HORIZON SPINAL SYSTEM (K102886) | Medtronic Sofamor Danek, Inc. | 2011-01-26 |