| DUAL SHOT ALPHA (K071691) | Nemoto Kyorindo Co., Ltd. | 2007-12-19 |
| MASTER-VU (K073196) | Sonomed, Inc. | 2007-12-19 |
| ARC SURGICAL BIOTRAK PIN SYSTEM (K071616) | Arc Surgical, LLC | 2007-12-19 |
| NON-IV ADAPTER FOR INFANT NG TUBE (K072756) | Promedic, Inc. | 2007-12-19 |
| PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES (K072951) | Sofradim Production | 2007-12-19 |
| THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT (K073220) | Prestige Brands, Inc. | 2007-12-19 |
| COLOR LCD MONITOR, FLEXSCAN MX300W (K073340) | Eizo Nanao Corporation | 2007-12-19 |
| MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006 (K071210) | Biomedical Diagnostics (Bmd) SA | 2007-12-19 |
| QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 (K072078) | Biokit, S.A. | 2007-12-19 |
| STRYKER NAVIGATION SYSTEM INFINITUS HIP RESURFACING MODULE (K072271) | Stryker Corp. | 2007-12-18 |
| VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM (K072180) | Vision-Sciences, Inc. | 2007-12-18 |
| MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM (K070356) | Medwaves Incorporated | 2007-12-18 |
| PERFORMAX SE TOTAL FACE MASK (K072588) | Respironics Inc., Sleep & Home Respiratory Group | 2007-12-18 |
| WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE) (K070060) | Welch Allyn, Inc. | 2007-12-18 |
| MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044 (K072796) | Concentric Medical, Inc. | 2007-12-18 |
| IDRIVES, IDRIVEC, IDRIVEF (K073001) | Power Medical Interventions, Inc. | 2007-12-18 |
| GE LOGIQ P6 (K073297) | General Electric Co. | 2007-12-18 |
| ACUSON X300 ULTRASOUND SYSTEM (K072676) | Siemens Medical Solutions USA, Inc. | 2007-12-18 |
| STERRAD 100NX TEST PACK (K071537) | Advanced Sterilization Products | 2007-12-18 |
| ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C (K071930) | Blue Cross Bio-Medical Co., Ltd. | 2007-12-18 |
| TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER (K072995) | Lumen Development and Manufacturing, Inc. | 2007-12-18 |
| SYNGO VOLUME PERFUSION-CT BODY (K073373) | Siemens AG Medical Solutions | 2007-12-18 |
| EMS PIEZON MASTER SURGERY (K072146) | E.M.S Electro Medical Systems S.A | 2007-12-18 |
| SAPPHIRE CERAMIC BRACKET (K073045) | Ortho Technology, Inc. | 2007-12-18 |
| SYNTHES (USA) 2.0MM TITANIUM T-PLATE (K072758) | Synthes (Usa) | 2007-12-18 |
| CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR (K071995) | Card Guard Scientific Survival , Ltd. | 2007-12-18 |
| CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM (K072537) | Creaspine Sas | 2007-12-18 |
| SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM (K073186) | Synthes (Usa) | 2007-12-17 |
| CROSS.BONE (K071876) | TriMed, Inc. | 2007-12-17 |
| METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS (K071679) | Disc-O-Tech Medical Technologies, Ltd. | 2007-12-17 |
| SMARTSITE STOPCOCK (K071400) | Cardinal Health, Alaris Products | 2007-12-14 |
| SYSTEM-ARMS, MODEL 390,E60 (K072553) | Bio-Medical Research, Ltd. | 2007-12-14 |
| PLASMAIR, MODEL T2006 (K070722) | Airinspace B.V. | 2007-12-14 |
| VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448 (K063243) | bioMerieux, Inc. | 2007-12-14 |
| MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE (K072552) | Merit Medical Systems, Inc. | 2007-12-14 |
| AMIGO INSULIN PUMP (K071613) | Nipro Diabetes Systems, Inc. | 2007-12-14 |
| SET PP (K073043) | Sdi , Ltd. | 2007-12-14 |
| AIR-FLOW MASTER STANDARD (K073284) | (Ems Sa) Electro Medical Systems | 2007-12-14 |
| HYALOMATRIX PA (K073251) | Fidia Advanced Biopolymers Srl | 2007-12-14 |
| MERILAS 532A (K072823) | Meridian AG | 2007-12-14 |
| FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C (K071353) | Shanghai Foshion Medical Instruments Co., Ltd. | 2007-12-14 |
| OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM (K073409) | Omniguide, Inc. | 2007-12-14 |
| POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS (K072657) | Smiths Medical MD, Inc. | 2007-12-14 |
| FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM (K072154) | Encore Medical L.P. | 2007-12-14 |
| PATIENT SAFE SYRINGE (K072654) | Retractable Technologies, Inc. | 2007-12-14 |
| THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT (K072476) | Boston Scientific Corporation | 2007-12-14 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVE, WHITE COLOR (K072377) | Xuzhou Full Sun Medical Products , Ltd. | 2007-12-14 |
| ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM (K072832) | DePuy Orthopaedics, Inc. | 2007-12-14 |
| WEINMANNCOMPACT, MODEL WM 27380; WEINMANNCLICK2, MODEL WM 27340 (K072009) | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2007-12-14 |
| ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (K072621) | Cincinnati Sub-Zero Products, Inc. | 2007-12-13 |
| SWABABLE VIAL ADAPTER 13MM, SWABABLE VIAL ADAPTER 20MM (K072511) | Medimop Medical Projects, Ltd. | 2007-12-13 |
| SCREWPLUS DENTAL IMPLANTS (HA) (K073049) | Implant Direct, LLC | 2007-12-13 |
| ISSYS LP SPINAL FIXATION SYSTEM (K072866) | Custom Spine, Inc. | 2007-12-13 |
| MIRAGE MICRO (K072940) | Resmed, Ltd. | 2007-12-13 |
| SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE (K070225) | Abiomed, Inc. | 2007-12-13 |
| SMARTPORT CT MP PORT ACCESS SYSTEM AND LIFEGUARD CT SAFETY INFUSION SET (K072375) | AngioDynamics, Inc. | 2007-12-13 |
| MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER (K072670) | Pari Innovative Manufacturers, Inc. | 2007-12-13 |
| SMH FLEX S (K073040) | Smh Biomaterial AG | 2007-12-13 |
| BEACON STABILIZATION SYSTEM (K073172) | Globus Medical, Inc. | 2007-12-13 |
| EDTA PLUS (K072555) | Essential Dental Systems, Inc. | 2007-12-13 |
| VIAL2BAG (K072759) | Medimop Medical Projects, Ltd. | 2007-12-13 |
| SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR (K070783) | Sopro | 2007-12-13 |
| ION MEDICAL BIPOLAR COAGULATION PEN (K072911) | Ion Medical, LLC | 2007-12-13 |
| TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) (K072625) | Cook, Inc. | 2007-12-13 |
| FD EMS, MODEL # D-FJ30E (K063642) | Fuji Dynamics Limited | 2007-12-13 |
| DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES (K071746) | Ansell Healthcare Products, LLC | 2007-12-13 |
| GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM (K072594) | Gyrus Acmi, Inc. | 2007-12-13 |
| PURITAN BENNETT LEGENDAIR XL2 (K070899) | Nellcor Puritan Bennett | 2007-12-13 |
| DISPOSABLE POWDERED VINYL EXAM GLOVE, YELLOW COLOR (K071122) | Xuzhou Full Sun Medical Products , Ltd. | 2007-12-12 |
| MODIFICATION TO: T-PORT HP INFUSION PORT (K073210) | Pfm Medical, Inc. | 2007-12-12 |
| ALCON MULTI-PURPOSE SOLUTION (K071236) | Alcon, Inc. | 2007-12-12 |
| NEUROSIGN LARYNGEAL ELECTRODES (K071349) | The Magstim Company , Ltd. | 2007-12-12 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR (K072314) | Xuzhou Full Sun Medical Products , Ltd. | 2007-12-12 |
| K-Y BRAND INTRIGUE INTENSE WARMING SENSATION (K072360) | Mcneil-Ppc, Inc. | 2007-12-12 |
| THE INVACARE FLYER, MODEL IPC 100 (K071928) | Invacare Corp. | 2007-12-12 |
| PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS (K072376) | Playtex Products, Inc. | 2007-12-12 |
| SMARTLIPO LASER (K073394) | Cynosure, Inc. | 2007-12-12 |
| ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114 (K072660) | Imtec Corp. | 2007-12-12 |
| COMPREHENSIVE RS SHOULDER SYSTEM (K072804) | Biomet Manufacturing Corp | 2007-12-12 |
| MODIFICATION TO:MAKO SURGICAL UNICONDYLAR KNEE SYSTEM (K073248) | Mako Surgical Corp. | 2007-12-12 |
| DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210 (K072717) | Dade Behring, Inc. | 2007-12-12 |
| PASSEO 18 (K072765) | Biotronik, Inc. | 2007-12-12 |
| ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000 (K072450) | Respironics California, Inc. | 2007-12-12 |
| TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE (K071150) | Heinz Kurz GmbH Medizintechnik | 2007-12-12 |
| ELITE GLASS (K073005) | Zhermack S.P.A. | 2007-12-12 |
| VERIFY V-PRO CHEMICAL INDICATOR, VERSIONS 1 AND 2 (K072510) | STERIS Corporation | 2007-12-11 |
| LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK (K072835) | Bio-Rad, Diagnostics Grp. | 2007-12-11 |
| PVMED DDR 2520 DIGITAL IMAGING SYSTEM (K072766) | Portavision Medical | 2007-12-11 |
| WORKSTATIONONE BREAST IMAGING WORKSTATION (K073272) | Three Palm Software, LLC | 2007-12-11 |
| EQUAL DOSE 1.0 (K073273) | Nucletron Corporation | 2007-12-11 |
| MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM (K071942) | Medtronic Sofamor Danek | 2007-12-11 |
| D3 HEMATOLOGY ANALYZER, MODEL D3 (K071562) | Drew Scientific, Inc. | 2007-12-11 |
| LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC (K072721) | Bio-Rad, Diagnostics Grp. | 2007-12-11 |
| DIVO (K072637) | A2d Imaging, LLC | 2007-12-11 |
| LEGACY DENTAL IMPLANTS (K073033) | Implant Direct, LLC | 2007-12-10 |
| CYTORI AFT SYSTEM (K072587) | Cytori Therapeutics, Inc. | 2007-12-10 |
| ICE-SENSE (K072883) | Arbel Medical , Ltd. | 2007-12-10 |
| CHASE MR SYSTEM (K072473) | Chase Medical, LP | 2007-12-10 |
| OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT (K072601) | Osteosymbionics, LLC | 2007-12-10 |
| STASILON FR (K072890) | Entegrion, Inc. | 2007-12-10 |