| AMSCO EVOLUTION MEDIUM STEAM STERILIZER, MODEL HC-900 AND HC-1200 (K091136) | STERIS Corporation | 2009-06-29 |
| CONMED LINVATEC ANODIZED ALUMINUM STERILIZATION TRAYS (K090560) | Conmed Linvatec | 2009-06-29 |
| TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS (K091325) | Cooper Surgical | 2009-06-29 |
| LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS (K091598) | Nucletron Corp. | 2009-06-29 |
| PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA. (K090884) | B.Braun Medical, Inc. | 2009-06-29 |
| DIGITAL X-RAY IMAGING SYSTEM, MODEL: CXD-DR80D (K083640) | Choong Wae Medical Corp. | 2009-06-29 |
| MORCE POWER PLUS AND VARIOCARVE MORCELLATOR (K080365) | NOUVAG AG | 2009-06-29 |
| CERAMIC PEDATRIC PREFORMED CROWN (K091362) | Ez-Pedo, Inc. | 2009-06-29 |
| MR CARDIAC FUNCTION ANALYSIS (K091262) | Ziosoft, Inc. | 2009-06-29 |
| NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER (K090885) | Nephros, Inc. | 2009-06-29 |
| GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA 4100, 3100, 2100, 3131, 2121 (K091658) | GE Healthcare | 2009-06-29 |
| FOTONA XP ND: YAG LASER SYSTEM FAMILY, FOTONA XP, XP-2 FOCUS, FOTONA XP CHANGER,MODEL MOO1-14F, MOO1-14F, MOO1-14F/2, (K090126) | Fotona D.D. | 2009-06-29 |
| MYRIAN 1.4 (K091001) | Intrasense | 2009-06-29 |
| HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L (K090980) | Olympus Winter & Ibe GmbH | 2009-06-29 |
| CERALAS MULTIWAVELENGTH 980/1470NM DIODE LASER (K090164) | Biolitec, Inc. | 2009-06-26 |
| WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730 (K091510) | Boston Scientific Corporation | 2009-06-26 |
| ARTHREX UNIVERS II SHOULDER PEGGED GLENOID (K083435) | Arthrex, Inc. | 2009-06-26 |
| ORTHOLOC ANKLE PLATING SYSTEM (APS) (K091243) | Wrightmedicaltechnologyinc | 2009-06-26 |
| THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES (K090580) | Solta Medical, Inc. | 2009-06-26 |
| GUARDIAN 150 ELECTRODE (K083756) | Selectivemed Components, Inc. | 2009-06-26 |
| LIFE SPINE FACET SCREW SPINAL SYSTEM (K090865) | Life Spine | 2009-06-26 |
| ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210 (K083256) | K-Jump Health Co., Ltd. | 2009-06-26 |
| ALICE PDX (K090484) | Respironics Inc., Sleep & Home Respiratory Group | 2009-06-26 |
| PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWS (K090877) | DePuy Orthopaedics, Inc. | 2009-06-26 |
| ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165 (K090583) | Apollo Endosurgery, Inc. | 2009-06-26 |
| PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 (K083119) | Smiths Medical Asd, Inc. | 2009-06-26 |
| VERICORE ABUTMENT IN ZIRCONIA FOR IMPLANT SYSTEMS (K090976) | Whip-Mix Corp. | 2009-06-25 |
| CHARTIS CONSOLE (K083199) | Pulmonx, Inc. | 2009-06-25 |
| LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK (K091317) | Bio-Medical Research, Ltd. | 2009-06-25 |
| MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM (K090507) | Ldr Spine USA | 2009-06-25 |
| CHARTIS CATHETER (K083883) | Pulmonx, Inc. | 2009-06-25 |
| VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET (K091225) | Maine Standards Co. | 2009-06-25 |
| COLLAWOUND WOUND DRESSING (K090894) | Collamatrix Co., Inc. | 2009-06-25 |
| E. COLI PNA FISH (K082068) | Advandx, Inc. | 2009-06-25 |
| VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN. (K090840) | Ventlab Corp. | 2009-06-25 |
| ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285 (K083685) | Mri Manufacturing and Research, Inc. | 2009-06-25 |
| XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116 (K091667) | Luminex Molecular Diagnostics, Inc. | 2009-06-25 |
| NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230 (K091546) | Noras Mri Products GmbH | 2009-06-24 |
| TDS ABUTMENT FOR NOBEL BIOCARE REPLACE (K091026) | Pou YU Biotechnology Co., Ltd. | 2009-06-24 |
| FULL BREATH SLEEP APPLIANCE LOWER (FBSL) (K091035) | Bryan Keropian Dds | 2009-06-24 |
| TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370 (K090564) | Truly Instrument Limited | 2009-06-24 |
| XIA 3 SPINAL SYSTEM, UNIPLANNER/REDUCTION SCREWS & VITALLIUM ROD (K091291) | Stryker Spine | 2009-06-24 |
| GE LIGHTSPEED ACT FP16 (K091673) | Ge Medical Systems, Inc. | 2009-06-24 |
| BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD (K090109) | Epocal, Inc. | 2009-06-24 |
| BRILLIANCE DUAL ENERGY OPTION (K090462) | Philips Medical Systems (Cleveland), Inc. | 2009-06-23 |
| ORTHOPILOT NEXT GENERATION-UKA SOFTWARE, MODEL FS210 (K090375) | Aesculap Implant System, Inc. | 2009-06-23 |
| RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R (K091055) | Rhythmlink International, LLC | 2009-06-23 |
| FEMVUE(TM) CATHETER SYSTEM (K083690) | Femasys, Inc. | 2009-06-23 |
| AXXENT FLEXISHIELD MINI (K090417) | Xoft, Inc. | 2009-06-23 |
| VISION TOOLS (K090668) | Millensys | 2009-06-23 |
| FORE V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244, FOREA V12 BLODO GLUCOSE MONITORING SYSTEM, MODEL TD-4247 (K090404) | Taidoc Technology Corporation | 2009-06-23 |
| RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R (K091056) | Rhythmlink International, LLC | 2009-06-23 |
| CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM (K091549) | Linvatec Corp. | 2009-06-23 |
| VINYL POWDERED EXAMINATION GLOVE (K091427) | Shun DA (Xinghua) Co., Ltd. | 2009-06-23 |
| JIAJIAN SELF-ADHESIVE ELECTRODE (K090198) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2009-06-23 |
| CODMAN ISOCOOL BIPOLAR FORCEPS (K083895) | Codman & Shurtleff, Inc. | 2009-06-23 |
| PORTALVISION ADVANCED IMAGING (K091209) | Varian Medical Systems, Inc. | 2009-06-23 |
| ARTHROCARE SYSTEM 15000 CONTOLLER, MODEL 72202149, ARTHROCARE ARTHROWANDS, MODEL 72202139,72202141, 72202143, 72202144 (K090393) | Arthrocare Corp. | 2009-06-23 |
| INTELEPACS, MODEL VERSION 3.X.X (K083520) | Intelerad Medical Systems Incorporated | 2009-06-23 |
| CERNER PROVISION WORKSTATION (VERSION 2.5) (K091032) | Cerner Corp. | 2009-06-22 |
| LAMBDA LIGHT CHAINS (K083601) | SENTINEL CH. SpA | 2009-06-22 |
| OSTENE CT, AOC CT, OSTEOTENE, CERETENE (K091636) | Ceremed , Inc. | 2009-06-22 |
| CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR (K090835) | Linvatec Corp. | 2009-06-22 |
| VIDAS CA 15-3 ASSAY (K080469) | bioMerieux, Inc. | 2009-06-22 |
| ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS (K091593) | Possis Medical, Inc. | 2009-06-22 |
| ANTI-WRINKLE LIGHT, MODEL 1302 AND PAIN THERAPY LIGHT, MODEL 1301 (K083580) | Led Intellectual Properties, LLC | 2009-06-22 |
| DEXIS SOFTWARE (K090431) | Dexis, LLC | 2009-06-22 |
| MICROPLEX COIL SYSTEM-COSMOS (K090891) | MicroVention, Inc. | 2009-06-22 |
| SMART-LOGIC AUTO DIGITAL UPPERARM BLOOD PRESSURE MONITOR, MODEL KP-7500, FULLY FUZZY AUTO DIGITAL UPPER ARM BLOOD PRESSU (K083753) | K-Jump Health Co., Ltd. | 2009-06-19 |
| CYBER SURGICAL LASER FAMILY INCLUDING: CYBER TM, CYBER GREEN, CYBER GREEN TM (K090962) | Quanta System Spa | 2009-06-19 |
| MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP (K083644) | Mako Surgical Corp. | 2009-06-19 |
| ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS (K082340) | Roche Diagnostics Corp. | 2009-06-19 |
| VARI-LASE PLATINUM BRIGHT TIP LASER FIBER (K091551) | Vascular Solutions, Inc. | 2009-06-19 |
| JETSTREAM G2 NXT SYSTEM, MODEL PV20300 (K091509) | Pathway Medical Technologies, Inc. | 2009-06-19 |
| DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K091680) | Edan Instruments, Inc. | 2009-06-19 |
| MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM (K082843) | Dentis Co., Ltd. | 2009-06-19 |
| VASCUTEK BRANCHED GELWEAVE (K090987) | Vascutek, Ltd. | 2009-06-19 |
| MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00 (K091504) | Micrus Endovascular Corporation | 2009-06-19 |
| DSS STABILIZATION SYSTEM (K090099) | Paradigm Spine, LLC | 2009-06-19 |
| AS 1000 ULTRASOUND WOUND THERAPY SYSTEM (K091038) | Arobella Medical, LLC | 2009-06-19 |
| NUVANT CARDIAC EVENT MONITORING SYSTEM; NUVANT MOBILE CARDIAC TELEMETRY SYSTEM (K090696) | Corventis, Inc. | 2009-06-19 |
| FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100 (K090621) | Flowcardia, Inc. | 2009-06-19 |
| ARTIS ZEE / ZEEGOS WITH SW VC14 (K090745) | Siemens Medical Solutions USA, Inc. | 2009-06-18 |
| CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM (K091518) | Mcube Technology Co., Ltd. | 2009-06-18 |
| POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM (K083305) | Wrp Asia Pacific Sdn. Bhd. | 2009-06-18 |
| PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS AVENT ANIMAL STAGE 2 AND 3 TEETHER, (K090167) | Philips Electronics UK Limited | 2009-06-18 |
| CAMLOG ABUTMENTS PS (K090347) | Altatec GmbH | 2009-06-18 |
| MUCHECK V8 (K091602) | Oncology Data Systems, Inc. | 2009-06-18 |
| NATURAZ SERIES, MODEL B16,B20, B42, B60, B98, B100 (K091096) | Dental Solutions, Inc. | 2009-06-18 |
| PIGGYBACK WIRE CONVERTER (K090977) | Vascular Solutions, Inc. | 2009-06-18 |
| TREVAIR CHAIR (K091478) | Patmont Motor Werks, Inc. | 2009-06-18 |
| VITEK 2 GRAM POSITIVE DAPTOMYCIN (K091126) | bioMerieux, Inc. | 2009-06-18 |
| MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM (K091492) | Varian Medical Systems, Inc. | 2009-06-18 |
| DDI ULTRASONIC NEBULIZER SYSTEM (K090307) | Diagnostic Devices, Inc. | 2009-06-18 |
| ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190 (K090939) | Roche Diagnostics | 2009-06-18 |
| KENS INTERNAL FIXATION SYSTEM (K090786) | Kens Finemedtech Sdn. Bhd | 2009-06-18 |
| INOMAX DS (DELIVERY SYSTEM) (K090958) | Ino Therapeutics, LLC | 2009-06-18 |
| BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM (K080941) | N.I. Medical, Ltd. | 2009-06-18 |
| ARAGON SURGICAL RF SYSTEM L2 INSTRUMENT (K090306) | Aragon Surgical, Inc. | 2009-06-18 |
| DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02 (K091449) | Datascope Corp., Cardiac Assist Division | 2009-06-18 |