| LAGIS ENDOSCOPIC INSTRUMENTS (K090309) | Lagis Enterprises Co, Ltd. | 2009-08-28 |
| PORTABLE DOSIMETER DOSE VERIFICATION SYSTEM, MODEL TD-RD-90 (K092285) | Best Medical Canada , Ltd. | 2009-08-28 |
| LEDA (K090762) | Quantel Derma GmbH | 2009-08-28 |
| PRIMER PLUS (K091705) | Bisco, Inc. | 2009-08-28 |
| VICKS POWERSHOT DRY THROAT & MOUTH RELIEF (K091419) | The Procter & Gamble Co. | 2009-08-28 |
| ELVIS HSV ID AND D3 TYPING TEST SYSTEM (K091753) | Diagnostic Hybrids, Inc. | 2009-08-28 |
| MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT (K092300) | Diagnostic Hybrids, Inc. | 2009-08-28 |
| INSPIRA HD, MODEL: NL1000 (K090811) | Neurologica Corporation | 2009-08-27 |
| MINISILK FT (K082040) | El.En Electronic Engineering Spa | 2009-08-27 |
| ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND (K083867) | Beckman Coulter, Inc. | 2009-08-27 |
| SYNGO.X (K092519) | Siemens AG Medical Solutions | 2009-08-27 |
| MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD (K090869) | Medtronic Perfusion Systems | 2009-08-27 |
| DIGITAL X-RAY SENSOR, MODEL E9539,E9505,E9502, E9540 (K092537) | Toshiba America Electronic Components, Inc. | 2009-08-27 |
| WMT COMPOSITE DBM (K083270) | Wrightmedicaltechnologyinc | 2009-08-27 |
| AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM (K091971) | Corventis, Inc. | 2009-08-27 |
| MAMMOSITE MULTI LUMEN (K092405) | Hologic, Inc. | 2009-08-27 |
| SEGUIN ANNULOPLASTY RING (K092310) | St Jude Medical | 2009-08-27 |
| FOX SV PTA CATHETER (K092286) | Abbott Vascular | 2009-08-27 |
| CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM (K091820) | Bayer Healthcare | 2009-08-26 |
| ERBE HYBRID KNIFE (K083608) | Erbe USA, Inc. | 2009-08-26 |
| SIGN HIP CONSTRUCT (SHC), MODEL: 701 (K083582) | Surgical Implant Generation Network (Sign) | 2009-08-26 |
| EKG-PLUS II SOFTWARE (K090895) | Bionet Co., Ltd. | 2009-08-26 |
| COLLASORB COLLAGEN WOUND DRESSING (K091338) | Hartmann-Conco, Inc. | 2009-08-26 |
| CORE*IT DUAL (K092572) | Spident Co., Ltd. | 2009-08-26 |
| INSUFLOW (K090456) | Lexion Medical, LLC | 2009-08-26 |
| XPECT FLU A & B (K092423) | Thermo Fisher Scientific | 2009-08-26 |
| ARTHROSCOPE (K091398) | Orthopedic Sciences, Inc. | 2009-08-26 |
| CHITOGAUZE,2 IN X 2 IN,8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN, 8PLY, 1 IN X 4 IN, 8PLY, CHITOGAUZE, PACKAGING STRIP, 1/2 (K092357) | Hem Con Medical Technologies, Inc. | 2009-08-25 |
| HEAD FIXATION ARC AND TABLE BASE (K091439) | Surgivision, Inc. | 2009-08-25 |
| SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES (K091144) | Synthes (Usa) | 2009-08-25 |
| SATURN ACTIVE LASER SYSTEM (K083208) | Research Instruments , Ltd. | 2009-08-25 |
| PROFEMUR HIP SYSTEM MODULAR NECKS (K091423) | Wrightmedicaltechnologyinc | 2009-08-25 |
| IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR (K092307) | Imasight, Inc. | 2009-08-25 |
| VENTURI NPWT V. II ADVANCED VACUUM SYSTEM (K090258) | Talley Medical | 2009-08-25 |
| NORDICBRAINEX SOFTWARE, VERSION 1.0 (K092102) | Nordicimaginglab AS | 2009-08-25 |
| COMMANDER 111, MODEL CD300-CD399 (K091821) | Cardiocom, LLC | 2009-08-25 |
| GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ (K092004) | GE Healthcare | 2009-08-25 |
| BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771 (K091292) | Becton, Dickinson and Company (BD) | 2009-08-25 |
| BLOOD PRESSURE MONITOR, MODEL FORA P11/TD-3019 (K091897) | Taidoc Technology Corporation | 2009-08-25 |
| DIRECTVISION GUIDE SYSTEM (K091600) | Percuvision, LLC | 2009-08-25 |
| CERNER FETALINK (VERSION 1.0) (K091251) | Cerner Corp. | 2009-08-25 |
| SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A (K090936) | Contec Medical System Co., Ltd. | 2009-08-25 |
| TANTALUM BEAD SET, MODEL P003175 (K090581) | Halifax Biomedical, Inc. | 2009-08-21 |
| MERCURY VCO2 (K092217) | Respironics Novametrix, Inc. | 2009-08-21 |
| GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTRASOUND (K092140) | Ge Medical Systems Israel, Ultrasound, Ltd. | 2009-08-21 |
| CLEAN PEAK FLOW METER (K091412) | Viasys Healthcare GmbH | 2009-08-21 |
| MYOSURE ROD LENS HYSTEROSCOPE (K091465) | Interlace Medical, Inc. | 2009-08-21 |
| CARE PAL, MODEL CPW-10X (K091430) | Digio2 International Co., Ltd. | 2009-08-21 |
| OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX (K091628) | Protec GmbH & Co. KG | 2009-08-21 |
| XTRACT SYRINGE KEYS (K091200) | Xtract Solutions, LLC | 2009-08-21 |
| 1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484 (K091902) | Invivo | 2009-08-21 |
| SKINTACT AND VARIOUS OTHER TRADENAMES (K092291) | Leonhard Lang GmbH | 2009-08-21 |
| AMSURE PVC INTERMITTENT CATHETER (K091306) | Amsino International, Inc. | 2009-08-21 |
| FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030) (K091452) | Cas Medical Systems, Inc. | 2009-08-21 |
| MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH (K092053) | Handpiece Headquarters | 2009-08-20 |
| LSVT C OR LSVT COMPANION, MODEL V.1 (K091682) | Lsvt Global, LLC | 2009-08-20 |
| CABLE, TRANSDUCER, MODEL 2400GN (K083448) | Conmed Corporation | 2009-08-20 |
| TERUMO PALL AL3X ARTERIAL FILTER (K083747) | Terumo Cardiovascular Systems Corp. | 2009-08-20 |
| BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP (K082977) | Mk Bio, Inc. | 2009-08-20 |
| MODIFICATION TO PROFLU+ ASSAY (K092500) | Prodesse, Inc. | 2009-08-20 |
| ADVANCE 913 MEDIAL PIVOT TIBIAL INSERT, ADVANCE 913 MEDIAL PIVOT TIBIAL BASE (K092201) | Wrightmedicaltechnologyinc | 2009-08-20 |
| TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE (K090783) | Tuttnauer U.S.A Co, Ltd. | 2009-08-20 |
| MERCURY CPAP (K090710) | Mercury Medical | 2009-08-20 |
| VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184, (K090960) | Hollister, Inc. | 2009-08-20 |
| THERMAPULSE (K092222) | Palomar Medical Products, Inc. | 2009-08-20 |
| CONTURA CAVITY MAINTENANCE CATHETER (K092323) | Senorx, Inc. | 2009-08-19 |
| MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014 (K092232) | Puricore, Inc. | 2009-08-19 |
| K-LASER K-1200, MODEL 12 W (K091497) | Eltech S.R.L | 2009-08-19 |
| SPECTRA SP II, SPECTRA DENTA II (K091320) | Lutronic Corporation | 2009-08-19 |
| ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS (K082699) | Roche Diagnostics | 2009-08-19 |
| KODAK 1500 INTRAORAL CAMERA (K091186) | Carestream Health, Inc. | 2009-08-18 |
| PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT (K083031) | Smiths Medical Asd, Inc. | 2009-08-18 |
| DISPOSABLE PRESSURE TRANSDUCER (K091408) | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2009-08-18 |
| NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS (K083250) | Aa Neuromed Corp. | 2009-08-18 |
| EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEM (K091481) | Eps Bio Technology Corp. | 2009-08-18 |
| KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BS (K090818) | KARL STORZ Endoscopy-America, Inc. | 2009-08-18 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-5917, KD-5915, KD-5031 (K091737) | Andon Health Co, Ltd. | 2009-08-18 |
| S. AUREUS PNA FISH (K091827) | Advandx, Inc. | 2009-08-18 |
| SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-388BD (K091738) | Andon Health Co, Ltd. | 2009-08-18 |
| SPECTRA FLUORESCENCE CARIES DETECTION DEVICE (K090169) | Air Techniques, Inc. | 2009-08-18 |
| SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-3917, KD 3909 (K091739) | Andon Health Co, Ltd. | 2009-08-18 |
| CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE (K091134) | Custom Spine, Inc. | 2009-08-17 |
| BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL (K091976) | Biomet Trauma | 2009-08-17 |
| PATHFAST CK-MB-II, PATHFAST MYO-II (K081360) | Mitsubishi Kagaku Iatron | 2009-08-17 |
| SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200 (K091533) | Garrison Dental Solutions | 2009-08-17 |
| AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES (K091074) | Encision, Inc. | 2009-08-17 |
| TISSU TRANS HARVEST TUBING (K092022) | Shippert Medical Technologies Corp. | 2009-08-17 |
| MEDI-6000 MEDICAL IMAGE DIGITIZER (K091288) | Microtek International, Inc. | 2009-08-14 |
| SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS (K083758) | The Electrode Store, Inc. | 2009-08-14 |
| ASFORA BULLET CAGE SYSTEM (K090048) | Medical Designs, LLC | 2009-08-14 |
| ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001 (K090332) | Arkray Factory USA, Inc. | 2009-08-14 |
| SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 (K091742) | Beckman Coulter, Inc. | 2009-08-14 |
| VITEK 2 GRAM NEGATIVE MEROPENEM (K091899) | bioMerieux, Inc. | 2009-08-14 |
| SCANSCOPE XT SYSTEM (K080564) | Aperio Technologies | 2009-08-14 |
| MODIFICATION TO: TSRH SPINAL SYSTEM (K090740) | Medtronic Sofamor Danek | 2009-08-14 |
| LENSX 550 LASER SYSTEM (K082947) | Lensx Lasers, Inc. | 2009-08-14 |
| ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS (K091123) | Siemens Healthcare Diagnostics | 2009-08-14 |
| B. BRAUN CONTIPLEX CONTINUOUS NERVE BLOCK SET (K090995) | B.Braun Medical, Inc. | 2009-08-14 |
| DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL (K091455) | Diazyme Laboratories | 2009-08-14 |
| BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE (K091461) | Cardiopulmonary Corp. | 2009-08-14 |