| REMSTAR AUTO A-FLEX (K091319) | Respironics Inc., Sleep & Home Respiratory Group | 2009-08-03 |
| FLEXITIME FLOW (K091494) | Heraeus Kulzer, Inc. | 2009-07-31 |
| TI-TAMED SPINAL SYSTEM (K070385) | Ti-Tamed (Pty), Ltd. | 2009-07-31 |
| SOFTLASE PRO, ORTHOLASE AND HYGIENELASE (K091796) | Zap Lasers, LLC | 2009-07-31 |
| PASS LP SPINAL SYSTEM (K083810) | Medicrea Technologies | 2009-07-31 |
| RAPID PROGRAMMER, VERSION 3.3.0 (K091993) | Advanced Neuromodulation Systems, Inc. (Ans Inc.) | 2009-07-31 |
| SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWS (K090949) | Synthes (Usa) | 2009-07-31 |
| MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN (K091178) | Mtp Medical Technical Promotion GmbH | 2009-07-31 |
| POWDER FREE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL CLAIM (K083410) | Wrp Asia Pacific Sdn. Bhd. | 2009-07-31 |
| BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611 (K090967) | Bd Biosciences | 2009-07-31 |
| HERO VASCULAR ACCESS DEVICE (K091491) | Hemosphere, Inc. | 2009-07-31 |
| MODIFICATION TO:FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556 (K091500) | Andon Health Co, Ltd. | 2009-07-31 |
| CHESSON LABS LIQUID BANDAGE (K083913) | Chesson Laboratory Associates, Inc. | 2009-07-31 |
| AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 (K083222) | Axis-Shield Diagnostics, Ltd. | 2009-07-31 |
| POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K083408) | Wrp Asia Pacific Sdn. Bhd. | 2009-07-31 |
| GLUCOMANAGER DATA MANAGEMENT SOFTWARE (K091229) | Eps Bio Technology Corp. | 2009-07-31 |
| MANTRA COMBO, MODEL MECS 320 (K091236) | Mantra Intl. (Hk) , Ltd. | 2009-07-30 |
| BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS (K090844) | Lin-Zhi International, Inc. | 2009-07-30 |
| HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2 (K091390) | Hdc S.R.L. | 2009-07-30 |
| AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002 (K090867) | Ep Dynamics, Inc. | 2009-07-30 |
| LNCS OXIMETRY SENSORS (K083719) | Masimo Corporation | 2009-07-30 |
| EXSALT SD7 WOUND DRESSING (K083870) | Exciton Technologies, Inc. | 2009-07-30 |
| PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM (K092015) | Smith & Nephew, Inc. | 2009-07-30 |
| NOVAPRO STRETCH VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE) (K091422) | Novapro Co., Ltd. | 2009-07-30 |
| MEDOS HILITE RESERVOIR, MODEL: 4030 (K083131) | Gish Biomedical, Inc. | 2009-07-30 |
| NFOCUS NEUROMEDICAL ECHO DISTAL ACCESS CATHETER (K090918) | Nfocus Neuromedical, Inc. | 2009-07-30 |
| RECRUIT MICROCATHETER (K091563) | Reverse Medical Corporation | 2009-07-30 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES (K091662) | Zhangjiagang Fengyuan Plastic Products Co., Ltd. | 2009-07-30 |
| SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND (K091013) | Advanced Medical Solutions Limited | 2009-07-30 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7962 (K091997) | Andon Health Co, Ltd. | 2009-07-30 |
| NEOSALUS LOTION (K091719) | Quinnova Pharmaceuticals | 2009-07-30 |
| CORDCAP (K091380) | Centrix, Inc. | 2009-07-30 |
| ELASTO-GEL MANUKA HONEY WOUND DRESSING (K083334) | Southwest Technologies, Inc. | 2009-07-30 |
| MODIFICATION TO: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE , MODEL 9076 (K091988) | Vertebral Technologies, Inc. | 2009-07-30 |
| THERAFORM STANDARD/SHEET (K090812) | Sewon Cellontech Co., Ltd. | 2009-07-30 |
| UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063 (K091190) | Zimmer Spine, Inc. | 2009-07-30 |
| AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027 (K092086) | Amerx Health Care Corp. | 2009-07-30 |
| ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040 (K091966) | Angioscore, Inc. | 2009-07-30 |
| 5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS (K090203) | Ebi, L.P. | 2009-07-30 |
| MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047 (K091961) | Concentric Medical, Inc. | 2009-07-30 |
| ATLAS WOUND MATRIX (K090954) | Wrightmedicaltechnologyinc | 2009-07-30 |
| ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE (K090850) | Apatech , Ltd. | 2009-07-30 |
| TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK (K091392) | Pou YU Biotechnology Co., Ltd. | 2009-07-30 |
| TDS ZIRCONIA ABUTMENT FOR NOBEL BIOCARE BRANEMARK (K091693) | Pou YU Biotechnology Co., Ltd. | 2009-07-30 |
| FORTEX PEDICLE SCREW SYSTEM (K090224) | X-Spine Systems, Inc. | 2009-07-30 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-738 AND KD-739 (K092045) | Andon Health Co, Ltd. | 2009-07-30 |
| POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL (K083409) | Wrp Asia Pacific Sdn. Bhd. | 2009-07-29 |
| BULLSEYE BILIARY STENT SYSTEM (K082093) | Squareone | 2009-07-29 |
| PANTA NAIL (DIA. 10MM), PANTA NAIL XL (K091788) | Newdeal Sas | 2009-07-29 |
| MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY (K091403) | Oncology Tech, LLC | 2009-07-29 |
| ATLAS IMPLANT SYSTEM - WIDE PLUS (K090054) | Cowellmedi Co., Ltd. | 2009-07-29 |
| PONTO PRO (K090996) | Oticon Medical AB | 2009-07-29 |
| NEUROSIGN AVALANCHE MOTOR NERVE MONITOR (K083242) | The Magstim Company , Ltd. | 2009-07-29 |
| HEART-EXERCISE (K091594) | Ge Medical Systems Information Technologies GmbH | 2009-07-29 |
| MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON (K092054) | Tosama D.D. | 2009-07-29 |
| MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM (K090210) | Olympus Medical Systems Corporation | 2009-07-29 |
| PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT (K091405) | Given Imaging , Ltd. | 2009-07-29 |
| APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 4.0R001 (K092179) | Toshiba America Medical Systems, In.C | 2009-07-29 |
| PLANMECA PROSENSOR (K091197) | Planmeca Oy | 2009-07-29 |
| ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM (K092159) | Medison Co., Ltd. | 2009-07-28 |
| PHILIPS NM3 MONITOR, MODEL 7900 (K091459) | Respironics Novametrix, LLC | 2009-07-28 |
| SHARP CHUTE (K091690) | Heathrow Scientific, LLC | 2009-07-28 |
| PMT HALO SYSTEM (K090733) | Pmt Corp. | 2009-07-28 |
| AL T LASER, MODEL AVI HPLL-12 (K091285) | Avicenna Laser Technology, Inc. | 2009-07-28 |
| HAEMOBAND MULTI-LIGATOR (K091519) | Haemoband Surgical, Ltd. | 2009-07-28 |
| EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA) (K083052) | Euroimmun Us, Inc. | 2009-07-28 |
| NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (K090828) | Ultrawin Sdn Bhd | 2009-07-28 |
| NAVIJECT SUB2-1P, MODEL: LP604430 (K092023) | Medicel AG | 2009-07-28 |
| PLS PORTABLE LIGHT SOURCE (K091829) | Optim, Inc. | 2009-07-28 |
| SPI DENTAL IMPLANT INICELL (K090154) | Thommen Medical AG | 2009-07-27 |
| VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730 (K090699) | Bio-Rad Laboratories, Inc. | 2009-07-27 |
| THERMOFLO HCH, THERMOFLO FILTER (K090738) | Arc Medical, Inc. | 2009-07-27 |
| SONOLITH I-SYS LITHOTRIPER (K083614) | Technomed Medical Systems, SA | 2009-07-27 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K091663) | Zhangjiagang Fengyuan Plastic Products Co., Ltd. | 2009-07-27 |
| GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID (K092122) | DePuy Orthopaedics, Inc. | 2009-07-27 |
| ACCUPEN (K083377) | Accutome Ultrasound, Inc. | 2009-07-27 |
| ALPINE PEDICLE SCREW SYSTEM (K090477) | Sanacor | 2009-07-27 |
| POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (K091147) | Smart Glove Corp. Sdn Bhd | 2009-07-27 |
| WALK400H (K091054) | Et Medical Devices Spa | 2009-07-27 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K091661) | Zhang Jia Gang Huayuan Plastic Co. , Ltd. | 2009-07-27 |
| PICA WHOLE BODY MRI SYSTEM (K091580) | Time Medical Limited | 2009-07-24 |
| EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLARY SCREW SYSTEM (K091577) | Extremity Medical, LLC | 2009-07-24 |
| JUMAO OXYGEN CONCENTRATOR, MODEL JM-07000HI, JM-07000I, JM-07000 (K090007) | Danyang Jumao Healthcare Equipment Co., Ltd. | 2009-07-24 |
| REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSOR (K090438) | Envitec-Wismar GmbH | 2009-07-24 |
| IMAGINE TC SKIN THERAPY SYSTEM (K083461) | Endymion Medical, Ltd. | 2009-07-24 |
| SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200 (K091513) | Edan Instruments, Inc. | 2009-07-24 |
| KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411 (K083105) | Bio-Medical Research, Ltd. | 2009-07-24 |
| E-STATIS 40 SYSTEM (K090937) | Scican , Ltd. | 2009-07-24 |
| MR-TOUCH OPTION (K083421) | Ge Medical Systems, LLC | 2009-07-24 |
| THERAFIRM ANTI-EMBOLISM STOCKINGS, THERAFIRM MEN'S AND WOMEN'S TROUSER SOCKS (K091141) | Knit-Rite, Inc. | 2009-07-24 |
| EXTRAFIX EXTERNAL FIXATION SYSTEM (K091258) | Qfx Technologies, Inc. | 2009-07-24 |
| DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 (K081603) | Heartforce Medical, Inc. | 2009-07-24 |
| UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE (K091985) | Ivy Biomedical Systems, Inc. | 2009-07-24 |
| SPINAL EDGE TITAN PEDICLE SCREW SYSTEM (K091110) | Spinal Edge, LLC | 2009-07-24 |
| 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER (K091185) | Hsiner Co., Ltd. | 2009-07-24 |
| AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT (K083074) | Advandx, Inc. | 2009-07-24 |
| RAMP RSV ASSAY (K091235) | Response Biomedical Corp. | 2009-07-24 |
| NUBIC AND RABEA DEVICES (K082848) | Signus Medizintechnik GmbH | 2009-07-24 |
| PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM (K091454) | Medtox Diagnostics, Inc. | 2009-07-24 |
| LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE, (K091294) | DePuy Orthopaedics, Inc. | 2009-07-24 |