| 15W CERALAS D 1470NM DIODE LASER, MODEL D1470 (K082225) | Biolitec, Inc. | 2008-12-03 |
| NO!NO! SKIN (K082423) | Radiancy (Israel) , Ltd. | 2008-12-03 |
| PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES (K082786) | Peak Surgical, Inc. | 2008-12-03 |
| COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE (K082535) | Surgical Devices, A Global Business Unit Covidien | 2008-12-01 |
| DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER (K082208) | Scivolutions, Inc. | 2008-12-01 |
| VERITAS COLLAGEN MATRIX (DRY) (K083039) | Synovis Surgical Innovations | 2008-11-26 |
| VALLEYLAB MICROWAVE ABLATION GENERATOR (K072687) | Covidien Lp, Formerly Know AS Valleylab, A Divison | 2008-11-25 |
| PRODIGY NPWT SYSTEM MODEL PRODIGY 800V (K082415) | Premco Medical Systems, Inc. | 2008-11-25 |
| VERTEBRAL ACCESS SYSTEM BY VIDACARE (K081713) | Vidacare Corporation | 2008-11-21 |
| AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM (K082284) | Alveolus, Inc. | 2008-11-20 |
| SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE (K082568) | Bovie Medical | 2008-11-17 |
| SRI LP DRAPE (K080796) | Sri/Surgical Express | 2008-11-17 |
| ULTRAWAVE III EX 1320 (K083207) | Quanta System Spa | 2008-11-14 |
| RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS (K082211) | Smith & Nephew, Inc. | 2008-11-14 |
| TANDA SKINCARE SYSTEM, MODEL: PTSCS (K080591) | Pharos Life Corporation | 2008-11-14 |
| LTM-BPS SURGICAL MESH (K082176) | Lifecell Corp. | 2008-11-14 |
| EZLASE 10W (K083069) | Biolase Technology, Inc. | 2008-11-13 |
| SRI LP GOWN (K080723) | Sri/Surgical Express, Inc. | 2008-11-13 |
| SERISCAFFOLD SURGICAL MESH (K080442) | Serica Technologies, Inc. | 2008-11-13 |
| SRI PLR GOWN (K080707) | Sri/Surgical Express | 2008-11-13 |
| AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE (K082762) | Aardvark Medical | 2008-11-12 |
| BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY (K082876) | Sharplight Technologies, Ltd. | 2008-11-10 |
| ARTHROCARE ARTHROWANDS (K082980) | Arthrocare Corp. | 2008-11-05 |
| LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE (K082101) | Sandstone Medical Technologies, LLC | 2008-11-05 |
| ARAGON ONESHOT SYSTEM (K081312) | Aragon Surgical, Inc. | 2008-10-31 |
| TEPHAFLEX ABSORBABLE SUTURE (K082178) | Tepha, Inc. | 2008-10-30 |
| CHROMOPHARE E 778 AND E 558 (K083066) | Berchtold Holding GmbH | 2008-10-30 |
| LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMS (K082721) | Photo Medex, Inc. | 2008-10-28 |
| CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980 (K082263) | Biolitec, Inc. | 2008-10-24 |
| PROFILE MULTI-PLATFORM SYSTEM (K081352) | Sciton, Inc | 2008-10-23 |
| MODIFICATION TO ZENIEVA (K082865) | Gorbec Pharmaceutical Services, Inc. | 2008-10-23 |
| FLASH N' GO (K082298) | Home Skinovations , Ltd. | 2008-10-23 |
| E-Z CLEAN ELECTROSURGICAL ELECTRODE (K081791) | Megadyne Medical Products, Inc. | 2008-10-21 |
| PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS (K080629) | Promedical Products Co., Ltd. | 2008-10-20 |
| COLLAMEND FM IMPLANT (K082687) | C.R. Bard, Inc. | 2008-10-17 |
| ELLIPSE MULTIFLEX (K081408) | Ellipse A/S | 2008-10-17 |
| ENCAGE BIPOLAR RF PROBE (K082954) | Trod Medical SA | 2008-10-17 |
| VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM (K082640) | Coloplast Manufacturing Us, LLC | 2008-10-17 |
| STRAIGHT FIRE HOLMIUM LASER FIBER (K082928) | Boston Scientific Corp | 2008-10-16 |
| CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISOR (K082258) | Crosstex International | 2008-10-16 |
| EVIS MD PLANTIUM BLUE (K082232) | Ageless Beauty Corporation | 2008-10-15 |
| CURATIVE980 DIODE LASER (K082445) | Oroscience, Inc. | 2008-10-15 |
| VNUS CLOSUREFAST INTRAVASCULAR CATHETER, MODELS CF7-7-60-2, CF7-7-100-2 (K082890) | Vnus Medical Technologies, Inc. | 2008-10-15 |
| ARTHROCARE CONTROLLER (SYSTEM 12000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS (K082666) | Arthrocare Corp. | 2008-10-15 |
| SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE (K082828) | Suturtek Incorporated | 2008-10-14 |
| NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM (K080275) | Iasis Medical, Inc. | 2008-10-09 |
| EXSUDEX WOUND DRAINAGE PUMP (K082311) | The Medical Company | 2008-10-08 |
| EVIS MD PLATINUM RED LIGHT THERAPY (K082247) | Ageless Beauty Corporation | 2008-10-08 |
| POWERLIPO LASER SYSTEM (K082096) | Lutronic Corporation | 2008-10-08 |
| HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B (K082202) | Barrx Medical, Incorporated | 2008-10-08 |
| BARD 3DMAX MESH (K081010) | Davol Inc., Sub. C. R. Bard, Inc. | 2008-10-07 |
| BOVIE ICON GENERAL PURPOSE RF GENERATOR (K082109) | Bovie Medical | 2008-10-02 |
| LUMAPROBE (K073000) | Clareblend, Inc. | 2008-10-01 |
| CLAREBLEND LED PROBES MODEL# 7201-415, 7204-631, 7205-830 (K073022) | Clareblend, Inc. | 2008-10-01 |
| VENTRIO HERNIA PATCH (K081777) | C.R. Bard, Inc. | 2008-09-29 |
| AED BIPOLAR FORCEPS, MODEL 13-1646 (K081553) | National Advanced Endoscopy Devices, Inc. | 2008-09-29 |
| SMOOTHKIT+ (K082004) | Osyris | 2008-09-26 |
| AED MONOPOLAR LAP ACCESSORIES (K081503) | National Advanced Endoscopy Devices, Inc. | 2008-09-25 |
| CHOOSTENT (K072094) | M.I.Tech Co., Ltd. | 2008-09-25 |
| SELLAS (K080382) | Dinona Co., Ltd. | 2008-09-24 |
| LAPAROSCOPIC AND ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES, LAPAROSCOPY RUDOLF SYSTEM (K073498) | Rudolf Medical GmbH + Co. KG | 2008-09-19 |
| VIVASCOPE SYSTEM, MODEL 1500, 3000 (K080788) | Lucid, Inc. | 2008-09-17 |
| CLARO (K080638) | Clrs Technology Corporation | 2008-09-17 |
| SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS (K081613) | American Medical Systems, Inc. | 2008-09-17 |
| MATRIX RF APPLICATOR (K073572) | Syneron Medical, Ltd. | 2008-09-17 |
| EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2 (K082279) | St Jude Medical | 2008-09-16 |
| SUPRAMESH EXTRA (K080216) | S. Jackson, Inc. | 2008-09-15 |
| ACCELAWAVE SYSTEM (K082484) | Genesis Biosystems, Inc. | 2008-09-12 |
| SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS (K081704) | Lumenis, Inc. | 2008-09-11 |
| BEAMER ARGON PROBE (K081644) | Conmed Corporation | 2008-09-10 |
| PASCAL SYNTHESIS DELIVERY SYSTEM (K081744) | Optimedica Corporation | 2008-09-09 |
| RENASYS EZ (K082426) | Smith & Nephew, Inc. | 2008-09-05 |
| POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330 (K080332) | Boston Scientific Corporation | 2008-09-05 |
| TBD ETHICON MESH (K082216) | ETHICON, Inc. | 2008-09-05 |
| CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM (K081225) | Cardica, Inc. | 2008-09-05 |
| ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED) (K080412) | Shanghai Pudong Jinhuan Medical Products Co., Ltd. | 2008-09-04 |
| ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN (K080795) | Kimberly-Clark Corp. | 2008-09-03 |
| STARLIGHT, MODEL PD9012 (K073317) | F.P. Rubinstein Y Cia S.R.L. | 2008-09-03 |
| MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES (K081042) | Bsd Medical Systems Corp. | 2008-09-03 |
| GENESIS (K081559) | Medisiss | 2008-08-28 |
| CLAROS NANO DENTAL LASER SYSTEM (K081652) | Elexxion AG | 2008-08-28 |
| ARTHROCARE ARTHROWANDS (K082323) | Arthrocare Corp. | 2008-08-28 |
| REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C (K071023) | Reach Surgical, Inc. | 2008-08-28 |
| BOSTON SCIENTIFIC SURGICAL MESH (K081275) | Boston Scientific Corp | 2008-08-27 |
| SCULPTURE 2.94 ER:YAG SYSTEM (K073158) | Hoya Conbio, Inc. | 2008-08-27 |
| SKINSENSE POLYISOPRENE UNDERGLOVE (K081180) | Molnlycke Health Care Us, LLC | 2008-08-26 |
| RHYTEC, INC., PORTRAIT PSR (K082197) | Rhytec Incorporated | 2008-08-22 |
| MEDILAS D FAMILY LASERS (K073427) | Dornier Medtech America, Inc. | 2008-08-20 |
| DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN (K073579) | Feg Textiltechnik Forschungs-Und Entwicklungsgesel | 2008-08-18 |
| SURGIMESH XB (K072974) | Aspide Medical | 2008-08-18 |
| MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE (K080530) | Cutera, Inc. | 2008-08-15 |
| BODY-JET (K082025) | Human Med AG | 2008-08-13 |
| PARIETEX COMPOSITE MONO PM MESH (K081126) | Sofradim Production | 2008-08-13 |
| SERIES SY DISPOSABLE ELECTROSURGICAL PAD (K082204) | Ventlab Corp. | 2008-08-13 |
| ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS (K081647) | Xodus Medical, Inc. | 2008-08-12 |
| OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY (K081939) | Omniguide, Inc. | 2008-08-12 |
| PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS (K081633) | Primed Medical Products, Inc. | 2008-08-11 |
| SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE (K081476) | Surgical Concept Designs | 2008-08-08 |
| ATRILAZE LASER ABLATION SYSTEM (K081457) | Medical Cv, Inc. | 2008-08-08 |
| FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER (K073664) | Injectimed, Inc. | 2008-08-08 |