| SURGI GLOVES (K073447) | Metacure Surgical Gloves Sdn Bhd | 2008-04-24 |
| PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A (K080627) | Promedical Products Co., Ltd. | 2008-04-24 |
| ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM (K080838) | Alveolus, Inc. | 2008-04-24 |
| SPARMAX ASPIRATOR, MODELS TC-2000V ND VC-701 (K080005) | Ding Hwa Co., Ltd. | 2008-04-24 |
| DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0 (K080918) | Depuy Mitek | 2008-04-23 |
| CENTURION SORBAVIEW OTC (K080524) | Tri-State Hospital Supply Corp. | 2008-04-23 |
| SPECTRA VRMIII Q-SWITCHED ND: YAG LASER SYSTEM AND DYE HANDPIECES (K080248) | Lutronic Corporation | 2008-04-23 |
| QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO) (K080985) | Surgical Specialties Corp | 2008-04-23 |
| ELIPO (K073715) | Syneron Medical, Ltd. | 2008-04-23 |
| AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT (K080507) | Ceremed , Inc. | 2008-04-21 |
| MODIFICATION TO ENDOFAST RELIANT SYSTEM (K080836) | Endogun Medical Systems | 2008-04-21 |
| 50W CERALAS D 1950NM DIODE LASER (K072682) | Biolitec, Inc. | 2008-04-18 |
| COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W (K080525) | Cook Urological, Inc. | 2008-04-17 |
| C-QUR LITE MESH V-PATCH (K080688) | Atrium Medical Corp. | 2008-04-16 |
| CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES (K072814) | Covidien | 2008-04-16 |
| PALOMAR ASPIRE LASER PLATFORM (K080567) | Palomar Medical Products, Inc. | 2008-04-16 |
| C-QUR EDGE MESH V-PATCH (K080691) | Atrium Medical Corp. | 2008-04-16 |
| WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X08 (K073219) | American Medical Systems, Inc. | 2008-04-10 |
| COOLTOUCH MODELS LC215 AND COOLLIPO (K080163) | New Star Lasers, Inc. | 2008-04-10 |
| CHROMOPHARE E-SERIES (K080857) | Berchtold Holding GmbH | 2008-04-10 |
| BOVIE IDS-400 ELECTROSURGICAL GENERATOR (K072041) | Bovie Medical | 2008-04-10 |
| PHARAON LIPO (K073617) | Osyris | 2008-04-09 |
| CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) (K080300) | Cutera, Inc. | 2008-04-08 |
| SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER (K080697) | Global USA Distribution, LLC | 2008-04-07 |
| HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810 (K080827) | Handan Hengyong Protective & Clean Products Co., L | 2008-04-04 |
| CRYOMINI (K080735) | Zimmer Elektromedizin GmbH | 2008-04-04 |
| LTM-T SURGICAL MESH (K080353) | Lifecell Corp. | 2008-04-03 |
| CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS (K073534) | Candela Corp. | 2008-04-03 |
| ONCOBIONIC SYSTEM (K080376) | Oncobionic Incorporated | 2008-04-02 |
| AESCULAP ENDOSCOPIC CLIP SYTEM (K080753) | Aesculap, Inc. | 2008-04-02 |
| ERBE VIO ESU, MODEL VIO 200 S (K080715) | Erbe USA, Inc. | 2008-04-02 |
| BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS (K080557) | Barrx Medical, Incorporated | 2008-04-02 |
| ARTHROCARE ORTHOWAND SURGICAL DEVICE (K080610) | Arthrocare Corp. | 2008-03-31 |
| GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP (K080698) | Senorx, Inc. | 2008-03-31 |
| PORTRAIT PSR, MODEL 745915 (K073111) | Rhytec Incorporated | 2008-03-27 |
| HABIB HEXABLATE 10 (K080717) | Emcision , Ltd. | 2008-03-27 |
| VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7542 (K080104) | Vascular Solutions, Inc. | 2008-03-26 |
| MODIFICATION TO PALOMAR LUX1540 HANDPIECE (K073583) | Palomar Medical Products, Inc. | 2008-03-26 |
| E-VAC (K073455) | New Leaf Medical, Inc. | 2008-03-25 |
| SURGISIS BIODESIGN TISSUE GRAFT (K073391) | Cook Biotech, Inc. | 2008-03-21 |
| QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE (K080680) | Surgical Specialties Corp | 2008-03-21 |
| ARTHROCARE IRRIGATION PUMP, MODEL SIP001-00, SIP001-01 (K080482) | Arthrocare Corp. | 2008-03-20 |
| SINUS SPACER (K072891) | Acclarent, Inc. | 2008-03-19 |
| TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560 (K073095) | Somatex Medical Technologies GmbH | 2008-03-19 |
| SUTTER ELECTROSURGICAL CABLES (K073450) | Sutter Medizintechnik GmbH | 2008-03-17 |
| PREVADH MESH (K073287) | Sofradim Production | 2008-03-13 |
| MODIFICATION TO REBOUND HRD (K080393) | Minnesota Medical Development, Inc. | 2008-03-13 |
| MOUNTABLE ENDOSCOPIC BLADE (K080133) | A.M. Surgical, Inc. | 2008-03-13 |
| ATRICURE COOLRAIL LINEAR PEN (K073605) | AtriCure, Inc. | 2008-03-11 |
| RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER (K073041) | Acclarent, Inc. | 2008-03-11 |
| IPULSE, MODEL I400 (K080406) | Cyden Limited | 2008-03-10 |
| IVS TUNNELLER DEVICES (K073164) | Covidien UK Manufacturing, Ltd. | 2008-03-05 |
| XTRAC ULTRA 2, MODEL AL10000 (K073659) | Photo Medex, Inc. | 2008-03-05 |
| FOTONA FIDELIS III ER:YAG/ND:YAG LASER SYSTEM FAMILY (K070355) | Fotona D.D. | 2008-03-04 |
| LIPOSAT BASIC (INFILTRATION PUMP), MODEL 92-007 688 (K072793) | Moeller Medical GmbH & Co. KG | 2008-03-04 |
| OMNILUX NEW-U (K072459) | Photo Therapeutics, Inc. | 2008-03-03 |
| MINITAPE EXTRA URETHRAL SLING (K073647) | Mpathy Medical Devices, Ltd. | 2008-03-03 |
| PRIMAEVA MEDICAL SYSTEM (K080145) | Primaeva Medical, Inc. | 2008-02-28 |
| AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE (K080006) | Cynosure, Inc. | 2008-02-28 |
| Q-PLUS T (K073549) | Quanta System Spa | 2008-02-28 |
| PETERIO UNIVERSAL LASER SCANNING HANDPIECE (K073048) | Scilex, Ltd. | 2008-02-28 |
| ELLMAN NOBLE ALLOY ELECTRODES (K071343) | Ellman International, Inc. | 2008-02-28 |
| 15W CERALAS D 1470NM DIODE LASER (K073063) | Biolitec, Inc. | 2008-02-27 |
| WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM (K073266) | Boston Scientific Corp | 2008-02-27 |
| MINITAPE URETHRAL SLING (K073646) | Mpathy Medical Devices, Ltd. | 2008-02-25 |
| ETHICON ENDO SURGERY ARTICULATING NEEDLE KNIFE, MODEL 2504 (K073046) | Ethicon Endo-Surgery, Inc. | 2008-02-25 |
| BIOMERIX SURGICAL MESH, MODEL: RCR-01 (K070961) | Biomerix Corporation | 2008-02-25 |
| FOX 1-980, FOX Q-1064, FOX-Q-810 (K073322) | A.R.C Laser GmbH | 2008-02-22 |
| SMITH & NEPHEW INTRADISCAL CATHETER SYSTEM (K073466) | Smith & Nephew, Inc. | 2008-02-22 |
| FOX 940, MODEL 940 (K071896) | Valam, Inc. | 2008-02-22 |
| ZIMMER MIS LIGHT (K080367) | Zimmer Spine, Inc. | 2008-02-22 |
| ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00; (K080282) | Arthrocare Corp. | 2008-02-15 |
| GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE (K062991) | Light Bioscience, LLC | 2008-02-15 |
| V-RASER DIODE LASER SYSTEM (K073332) | Hoya Conbio, Inc. | 2008-02-14 |
| REPROCESSED SCISSOR TIPS (K073613) | Sterilmed, Inc. | 2008-02-12 |
| WATERLASE AND WATERLASE MD (K071363) | Biolase Technology, Inc. | 2008-02-12 |
| MENISCAL CINCH (K073149) | Arthrex, Inc. | 2008-02-11 |
| ANCHORAGE CLOSURE DEVICE (K073096) | Epitek, Inc. | 2008-02-07 |
| SANARUS V2 TREATMENT SYSTEM (K073533) | Sanarus Medical, Inc. | 2008-02-07 |
| NEOTRACT ANCHOR SYSTEM (K073651) | Neotract, Inc. | 2008-02-01 |
| SPECTRA HAIR REMOVAL LASER (K053527) | Spectragenics, Inc. | 2008-02-01 |
| CYNOSURE SMARTLIPO MULTIWAVLENGTH LASER (K080121) | Cynosure, Inc. | 2008-01-31 |
| AMS MINIARC SLING SYSTEM (K073703) | American Medical Systems, Inc. | 2008-01-30 |
| WATERLASE MD DERM (K071734) | Biolase Technology, Inc. | 2008-01-25 |
| CERALAS D 980NM DIODE LASER, MODELS D15 AND D25 (K072779) | Biolitec, Inc. | 2008-01-24 |
| P-NAIN SYSTEM (K072833) | Jeisys Medical, Inc. | 2008-01-24 |
| SILK'N (K072906) | Home Skinovations , Ltd. | 2008-01-23 |
| OPTILITE HOLMIUM LASER FIBERS (K073496) | Cook Urological, Inc. | 2008-01-23 |
| VERSA LITE (K073503) | Diomedics, Inc. | 2008-01-23 |
| IPULSE, QUADRA Q4 PLATINUM SERIES, MODEL(S) 1200+SERIES 2, 1300 SERIES 2, Q4 SERIES 2 (K071883) | Cyden Limited | 2008-01-23 |
| ANGIODYNAMICS, INC., NEVERTOUCH II 400UM FIBER AND VENACURE PROCEDURE KIT (K073464) | AngioDynamics, Inc. | 2008-01-23 |
| CYTOPHIL TISSUE MARKER (K072219) | Cytophil, Inc. | 2008-01-18 |
| BLACK AND BLACK ELECTROSURGICAL CUTTING AND COAGULATION FORCEPS AND ELECTRODES (K072124) | Black & Black Surgical, Inc. | 2008-01-18 |
| MODIFICATION TO THERMAGE THERMACOOL SYSTEM (K072849) | Thermage, Inc. | 2008-01-18 |
| DERMAPAL WITH DIGITAL TIMER (K073587) | Daavlin Distributing Co. | 2008-01-18 |
| ORTHO-WRAP BIORESORBABLE SHEET (K072190) | Mast Biosurgery | 2008-01-16 |
| PIVIT CRM (TYRX ANTIMICROBIAL PACEMAKER POUCH), MODEL CMRM-0601 (K063091) | Tyrx Pharma, Inc. | 2008-01-16 |
| MICROWAVE TISSUE COAGULATION SYSTEM (MTCS) (K072870) | Foundry Newco X, Inc. | 2008-01-14 |
| CANDELA-INOLASE SERENITY PRO PSF SYSTEM (K072925) | Inolase, Ltd. | 2008-01-10 |
| VARI-LASE WIRE FIBER (K072332) | Vascular Solutions, Inc. | 2008-01-10 |