| STREAMLINE TL SPINAL SYSTEM (K110692) | Pioneer Surgical Technology, Inc. | 2011-05-12 |
| AVEA VENTILATOR (K103211) | Care Fusion | 2011-05-12 |
| UPD-Y0003 (K103312) | Olympus Medical Systems Corporation | 2011-05-12 |
| ACTIVECARE SFT (K110159) | Medical Compression Systems (Dbn) , Ltd. | 2011-05-12 |
| ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET (K103716) | Roche Diagnostics | 2011-05-12 |
| SIMPLEABI (K110628) | Newman Medical | 2011-05-12 |
| ELECSYS PROLACTIN II CALCHECK 5 (K110613) | Roche Diagnostics | 2011-05-12 |
| CLEARBLUE EASY PREGNANCY TEST (K110433) | SPD Development Company Limited | 2011-05-12 |
| POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS (K110413) | Beckman Coulter, Inc. | 2011-05-11 |
| ACHILLES (K103633) | Ge Medical Systems China Co., Ltd. | 2011-05-11 |
| RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM (K110965) | Renovis Surgical Technologies, LLC | 2011-05-11 |
| A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX (K103525) | International Biomedical, Ltd. | 2011-05-11 |
| ASPIRA PLEURAL DRAINAGE SYSTEM (K110409) | C.R. Bard, Inc. | 2011-05-11 |
| IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 (K100910) | Siemens Medical Solutions Diagnostics | 2011-05-11 |
| DOLPHIN IMAGING (K110430) | Patterson Dental Supply, Inc. | 2011-05-11 |
| 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX (K103523) | International Biomedical, Ltd. | 2011-05-11 |
| INTEGRA LED SURGICAL HEADLIGHT SYSTEM (K110528) | Integra LifeSciences Corporation | 2011-05-11 |
| AGILIS NXT STEERABLE INTRODUCER (K110450) | St Jude Medical | 2011-05-10 |
| K-Y BRAND LONG LASTING VAGINAL MOISTURIZER (K101585) | Johnson & Johnson Consumer & Personal Products Wor | 2011-05-10 |
| WEXLER ENDOSCOPE ACCESSORIES (K110121) | Microsurgical Laboratories,Inc.Dba Wexler Surgical | 2011-05-10 |
| ALCON MULTI-PIRPOSE DISINFECTING SOLUTION (K102860) | Alcon Research, Ltd. | 2011-05-10 |
| PEARL DIABETES MANAGEMENT SYSTEM (K100567) | M2 Group Holdings, Inc. | 2011-05-10 |
| GLADIATOR PLASMA CLASSIC HIP STEM (K110399) | Wrightmedicaltechnologyinc | 2011-05-10 |
| STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE/CLEAR(NON-COLORED) (K110314) | True Glove Factory | 2011-05-10 |
| CROSSBOSS CATHETER MODEL M-2000, STINGRAY ORIENTING BALLOON CATHETER MODEL M-1000, STINGRAY GUIDEWIRE MODEL M-3004 AND M (K102725) | Bridge Medical, Inc. | 2011-05-10 |
| DYNACOR LUBRICATION GEL (K103718) | Medline Industries, Inc. | 2011-05-10 |
| BAHA 3 POWER SOUND PROCESSOR (K110996) | Cochlear Americas | 2011-05-10 |
| CELOX RAPID GAUZE (K110386) | Medtrade Products , Ltd. | 2011-05-10 |
| TORNIER BIOFIBER SCAFFOLD (K102788) | Tornier, Inc. | 2011-05-10 |
| DIOPSYS NOVA VEP VISION TESTING SYSTEM (K101763) | Diopsys, Inc. | 2011-05-09 |
| UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION (K103611) | United States Endoscopy Group, Inc. | 2011-05-09 |
| CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER (K110751) | Codman & Shurtleff, Inc. | 2011-05-09 |
| RANDOX METHAMPHETAMINE ASSAY (K092266) | Randox Laboratories, Ltd. | 2011-05-09 |
| MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30 (K102182) | Maquet Critical Care AB | 2011-05-09 |
| ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS (K100263) | Seppim S.A.S. | 2011-05-06 |
| NANOGEN (K102208) | Orthogen, LLC | 2011-05-06 |
| APEX MEDICAL WIZARD SERIES CPAP MASK (K103174) | Apex Medical Corp. | 2011-05-06 |
| EUNITY (K111164) | Client Outlook, Inc. | 2011-05-06 |
| UNIMAX SPECIMEN RETRIEVAL SYSTEM (K103510) | Unimax Medical Systems, Inc. | 2011-05-06 |
| DIAMOND-FLEX(R) GRASPERS (K110257) | Carefusion 2200, Inc. | 2011-05-06 |
| GE LUNAR VISCERAL FAT SOFTWARE (K103730) | Ge Medical Systems Ultrasound and Primary Care Dia | 2011-05-06 |
| STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING (K111015) | Cardinal Health, Inc. | 2011-05-06 |
| LIC INSTRUMENT PROCESSING SYSTEM (K101158) | Langford IC Systems, Inc. | 2011-05-06 |
| INDISTRIP GREEN (K110369) | Indilab, Inc. | 2011-05-06 |
| MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL (K103364) | Diamond Diagnostics, Inc. | 2011-05-06 |
| LOTUS BLAKE ESTEEM SCOOTER (K103771) | Letrix Power Hangzhou Pty, Ltd. | 2011-05-06 |
| INNOVA WHEELCHAIR (K110788) | Columbia Medical Manufacturing, LLC | 2011-05-06 |
| COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) (K102141) | Cook Urological, Inc. | 2011-05-06 |
| ASPIRA PERITONEAL DRAINAGE SYSTEM (K110396) | C.R. Bard, Inc. | 2011-05-06 |
| URIC ACID MODEL 3P39 (K102568) | Abbott Laboratories | 2011-05-06 |
| FORCETRIAD (K102913) | Covidien, Formerly Valleylab, A Division of Tyco H | 2011-05-06 |
| VENODYNE V810 (K110358) | Microtek Medical, Inc. | 2011-05-05 |
| ENSITE VELOCITY SYSTEM (K110549) | St Jude Medical | 2011-05-05 |
| TITAN (K103760) | Interacoustics A/S | 2011-05-05 |
| ISSYS LP SPINAL FIXATION SYSTEM (K111099) | Custom Spine, Inc. | 2011-05-05 |
| RADIOVISION (K111102) | Haas Software | 2011-05-05 |
| REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N (K103835) | Howmedica Osteonics Corp. | 2011-05-05 |
| IE-ZEN (IN CLEAR SERIES HEARING AID) (K110973) | Widex USA | 2011-05-05 |
| ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM (K110963) | Globus Medical, Inc. | 2011-05-05 |
| HLS KNEETEC SYSTEM (K094013) | Tornier | 2011-05-05 |
| HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0 (K102263) | Mckesson Information Solutions, LLC | 2011-05-05 |
| RELYX LUTING PLUS AUTOMIX (K111185) | 3M Espe Dental Products | 2011-05-05 |
| KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT (K102342) | Microphage, Inc. | 2011-05-05 |
| CENTRICITY PACS (K110875) | GE Healthcare | 2011-05-05 |
| OWL RF PROBES (K110593) | Diros Technology, Inc. | 2011-05-05 |
| GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS (K102307) | Genoss Co., Ltd. | 2011-05-04 |
| REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528 (K103764) | Medtronic, Inc. | 2011-05-04 |
| QUICK UP (K110440) | Voco GmbH | 2011-05-04 |
| ADVIA CENTAUR TOXOPLASMA IGG (TOXO G) (K102681) | Siemens Healthcare Diagnostics, Inc. | 2011-05-04 |
| HARDYCHROM MRSA (K102922) | Hardy Diagnostics | 2011-05-04 |
| AFFYMETRIX GENE PROFILING REAGENTS (K103112) | Affymetrix, Inc. | 2011-05-04 |
| SENSILASE PAD-IQ (K110438) | Vasamed, Inc. | 2011-05-04 |
| ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM (K102324) | Wrightmedicaltechnologyinc | 2011-05-04 |
| CORIN TRINITY ACETBULAR SYSTEM WITH HXLPE LINERS (K110087) | Corin USA | 2011-05-03 |
| DILON 6800 ACELLA (ACELLA) (K110384) | Dilon Technologies, Inc. | 2011-05-03 |
| ORIGEN DBM WITH BIOACTIVE GLASS, NANOFUSE DBM (K110976) | Nanotherapeutics, Inc. | 2011-05-03 |
| PREMIER C. DIFFICILE GDH (K110620) | Meridian Bioscience, Inc. | 2011-05-03 |
| MAC MALE ADAPTER (K102843) | Biomet Trauma (Aka Ebi, LLC) | 2011-05-03 |
| BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM (K110039) | Biomet Sports Medicine | 2011-05-03 |
| ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID (K110446) | Roche Diagnostics | 2011-05-03 |
| READY VIEW (K110573) | Ge Healthcare (Ge Medical Systems Scs) | 2011-05-03 |
| PICCOLO COMPOSITE NAILING SYSTEM (K111056) | CarboFix Orthopedics , Ltd. | 2011-05-03 |
| ICON ADULT MANUAL (K110985) | Icon Wheelchairs, Inc. | 2011-05-03 |
| CLEAR+BRILLIANT LASER SYSTEM (K110349) | Solta Medical, Inc. | 2011-05-03 |
| TINNITUS SOUND GENERATOR MODULE (K110932) | Gn Resound A/S | 2011-05-03 |
| WEBSTER DUO-DECAPOLAR CATHETER (K101991) | Biosense Webster, Inc. | 2011-05-02 |
| TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER;TRANSTEK GLASS BODY ANALYZER (K102191) | Zhongshan Transtek Electronics Co., Ltd. | 2011-05-02 |
| DURAFIBER AG (K103793) | Smith & Nephew, Inc. | 2011-05-02 |
| DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA (K093640) | Electron Jsco. | 2011-04-29 |
| KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS (K110455) | Kimberly-Clark Corp. | 2011-04-29 |
| FORTROSS BONE VOID FILLER (K110561) | Pioneer Surgical Technology | 2011-04-29 |
| REUSABLE TEST PACK FOR DANA EMULATING INDICATORS (K110253) | Dana Products, Inc. | 2011-04-29 |
| EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY WIRE-WORKHORSE-190CM / 315CM, BAREWIRE FILTER DEL.. (K110909) | Abbott Laboratories | 2011-04-29 |
| AGACHAMBER SPACER (K101348) | Aga Plastic Ind. Com. Ltda. | 2011-04-29 |
| MAC 5500 HD, MAC 3500 (K110266) | Ge Medical Systems Information Technologies, Inc. | 2011-04-29 |
| PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID (K110037) | Heraeus Kulzer, LLC | 2011-04-29 |
| L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT) (K103343) | Bioness, Inc. | 2011-04-29 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K103196) | Changda Plastic Product Co., Ltd. | 2011-04-29 |
| PTS-X SIZING BALLOON CATHETER (K110903) | NuMED, Inc. | 2011-04-29 |
| MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10 (K103758) | MicroVention, Inc. | 2011-04-28 |