| PKS OMNI INSTRUMENT (K081766) | Gyrus-Acmi L.P. | 2008-08-08 |
| LASERPEEL SOFT-MET MODIFIED ERBIUM LASER (K082028) | Global USA Distribution, LLC | 2008-08-08 |
| FAMILI OF IRIDEX IQ LASER SYSTEMS (K071687) | Iridex Corp | 2008-08-07 |
| HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM (K080966) | Aoti , Ltd. | 2008-08-06 |
| GYRUS ACMI PLASMAKINETIC (PK) SUPERPULSE SYSTEM, MODEL 744000 AND DUAL FOOTSWITCH CONNECTOR CABLE, MODEL 710003 (K082054) | Gyrus Acmi, Inc. | 2008-08-06 |
| STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS (K081085) | Senorx, Inc. | 2008-08-01 |
| NANNOLIGHT INTENSE PULSED LIGHT SYSTEM (K082033) | Global USA Distribution, LLC | 2008-07-31 |
| GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH CONNECTOR CABLE (K081954) | Gyrus Acmi, Inc. | 2008-07-31 |
| PORCINE SURGICAL MESH; DERMAL MATRIX (K081272) | Brennen Medical, LLC | 2008-07-31 |
| MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) (K081698) | Image Stream Medical, Inc. | 2008-07-30 |
| GENADYNE A4 POWERED SUCTION PUMP (K080745) | Genadyne Biotechnologies, Inc. | 2008-07-30 |
| LTC VAD SYSTEM, MODELS #VAD.400 (ELECTROSURGICAL GENERATOR); PCS-900 AND PCC-900 (HAND PIECE INSTRUMENTS) (K071759) | Live Tissue Connect, Inc. | 2008-07-30 |
| CONMED BEAMER SYSTEM C600 (K081678) | Kls Martin GmbH + Co. KG | 2008-07-29 |
| ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, ETRIO-314D,-325D,-335D,-345D, ENSEAL UNIVERSAL (K081129) | Surgrx, Inc. | 2008-07-28 |
| INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30V (K081826) | Power Medical Interventions, Inc. | 2008-07-25 |
| EPICOR ABLATION SYSTEM (K080292) | St Jude Medical | 2008-07-25 |
| SURGICRAFT SURGICAL MESH SYSTEM (K072370) | Surgicraft , Ltd. | 2008-07-24 |
| MEG LAPAROSCOPIC ELECTRODES (K081431) | Bovie Medical | 2008-07-24 |
| MEDELA INVIA WOUND THERAPY (K080357) | Medela AG | 2008-07-24 |
| ZENIEVA (K073246) | Gorbec Pharmaceutical Services, Inc. | 2008-07-23 |
| POWER ASPIRATOR, MODEL LS2 OR LS2DP (K081593) | Medical Device Resource Corp. | 2008-07-23 |
| MEDELA THOPAZ, MODEL 200 0288 (K080212) | Medela AG | 2008-07-23 |
| ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES (K080463) | Alma Lasers , Ltd. | 2008-07-23 |
| FAS-CLEAN ELECTROSURGICAL COATED ACTIVE BLADE (K073616) | Electromedics Co. , Ltd. | 2008-07-23 |
| PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040 (K073057) | Peak Surgical, Inc. | 2008-07-22 |
| ENDODRAPE(TM) (K080341) | Vortek Surgical, LLC | 2008-07-21 |
| SIALO DRAIN (K072334) | Sialo Technology, Ltd. | 2008-07-18 |
| CHROMOLITE EP (K081619) | Chromogenex Technologies Limited | 2008-07-18 |
| PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE (K080731) | Osyris | 2008-07-17 |
| FENCER 308 EXCIMER LASER SYSTEM (K080975) | Kera Harvest/Laser Max Medical Technologies Corp | 2008-07-15 |
| VENTURI NEGATIVE PRESSURE WOUND THERAPY SYSTEM (K080897) | Talley Medical | 2008-07-15 |
| KUMAR T-ANCHORS HERNIA SET (K081366) | Nashville Surgical Instruments | 2008-07-15 |
| TEPHAFLEX ABSORBABLE SUTURE (K081099) | Tepha, Inc. | 2008-07-15 |
| MODIFICATION TO XYLOS SURGICAL MESH (K081882) | Xylos Corporation | 2008-07-11 |
| KEY LASER III 1243 US WITH DETECT (K073074) | Kavo America | 2008-07-10 |
| LIPO CANNULA (K081039) | Millennium Medical Technologies, Inc. | 2008-07-10 |
| SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM (K070779) | Misonix, Inc. | 2008-07-09 |
| CERALAS D 980NM DIODE LASER, MODELS D15 AND D25 (K081015) | Biolitec, Inc. | 2008-07-08 |
| MOSAIC ECO2 LASER SYSTEM (K080496) | Lutronic Corporation | 2008-07-07 |
| ONCOBIONIC BIPOLAR ELECTRODE (K080287) | AngioDynamics, Inc. | 2008-07-03 |
| UNIBLATE ELECTROSURGICAL DEVICE (K080451) | AngioDynamics, Inc. | 2008-07-03 |
| ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP (K080972) | Ethicon Endo-Sugery, LLC | 2008-07-03 |
| FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES (K080915) | Reliant Technologies, Inc. | 2008-07-01 |
| APOLLO MINI IPL SYSTEM (K081219) | Sandstone Medical Technologies, LLC | 2008-06-30 |
| ALMA LASERS FAMILY OF THERMO-XEL HANDPIECES, PIXEL MODELS: 2940, 1060 (K072182) | Alma Lasers , Ltd. | 2008-06-27 |
| DORNIER MEDILAS D 30 LASER, MEDILAS D 1064 (K080959) | Dornier Medtech America, Inc. | 2008-06-27 |
| ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT) (K081146) | Ethicon Endo-Surgery, LLC | 2008-06-26 |
| CABS'AIR (K072962) | Cousin Biotech Sas | 2008-06-26 |
| AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERS (K081612) | Aesculight, LLC | 2008-06-25 |
| CONMED GOLDVAC INTEGRATED SMOKE EVACUATION PENCIL (K081634) | Conmed Corporation | 2008-06-25 |
| LITE WAND II (K080962) | Thompson Surgical Instruments, Inc. | 2008-06-25 |
| PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM (K080197) | Plasma Surgical, Ltd. | 2008-06-24 |
| PALOMAR LUX 1540 HANDPIECE (K080244) | Palomar Medical Products, Inc. | 2008-06-20 |
| ACCELA SYSTEM (K081578) | Genesis Biosystems, Inc. | 2008-06-20 |
| MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO (K081628) | New Star Lasers, Inc. | 2008-06-20 |
| BEAMER ARGON SNARE PROBE (K081580) | Conmed Corporation | 2008-06-19 |
| RELIMESH (K081327) | Herniamesh S.R.L. | 2008-06-19 |
| TUTOPATCH, TUTOMESH (K081538) | Rti Biologics, Inc. | 2008-06-19 |
| CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS (K081324) | Candela Corp. | 2008-06-17 |
| ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) (K072560) | Teikoku Pharma USA, Inc. | 2008-06-17 |
| WATERLASE, VERSION 3.0 (K081589) | Biolase Technology, Inc. | 2008-06-13 |
| WG-SURGICAL SUTURES WITH NEEDLE (K080684) | Foosin Medical Supplies, Inc. | 2008-06-09 |
| MOSAIC LASER SYSTEM (K080932) | Lutronic Corporation | 2008-06-09 |
| TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTURE (K081003) | Sutures India Pvt., Ltd. | 2008-06-09 |
| PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE (K081001) | Sutures India Pvt., Ltd. | 2008-06-09 |
| MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE (K081002) | Sutures India Pvt., Ltd. | 2008-06-09 |
| GORE INFINIT MESH (K081069) | W. L. Gore & Associates, Inc. | 2008-05-30 |
| PALOMAR ASPIRE LASER PLATFORM (K081416) | Palomar Medical Products, Inc. | 2008-05-29 |
| PROSTATE TISSUE MARKER (K081170) | Senorx, Inc. | 2008-05-28 |
| PARIETEX PROGRIP MESH (K081050) | Sofradim Production | 2008-05-28 |
| ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES (K072859) | Internacional Farmaceutica, S.A. DE C.V. | 2008-05-23 |
| ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM (K072564) | Alma Lasers , Ltd. | 2008-05-23 |
| ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES (K072863) | Internacional Farmaceutica, S.A. DE C.V. | 2008-05-23 |
| ECHELON GRAY CARTRIDGE, MODEL ERC45M (K080839) | Ethicon Endo-Surgery, LLC | 2008-05-21 |
| BIOSYAG MEDICAL SYSTEM (K080374) | Bios S.R.L. | 2008-05-15 |
| COLLAGEN TENDON WRAP (K080452) | Collagen Matrix, Inc. | 2008-05-15 |
| STYLA MICROLASER AND STYLAORTHO (K081214) | Zap Lasers, LLC | 2008-05-14 |
| LITEDUO (K073411) | Light Instruments | 2008-05-13 |
| PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS (K073477) | Photonova Ofsweden AB | 2008-05-09 |
| OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS (K080187) | Olsen Medical | 2008-05-09 |
| PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM (K080674) | PAJUNK GmbH Medizintechnologie | 2008-05-09 |
| EVOLUTION ESOPHAGEAL STENT SYSTEM (K080359) | Cook Ireland, Ltd. | 2008-05-09 |
| ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT (K080202) | Oncobionics, Inc. | 2008-05-08 |
| DESARA MESH SLING, MODEL CAL-DS01 (K072456) | Caldera Medical, Inc. | 2008-05-08 |
| OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167 (K073207) | Celon AG Medical Instruments | 2008-05-08 |
| U-CLIP UNI-FIRE, MODEL M65 (K081082) | Medtronic, Inc. | 2008-05-07 |
| HEPATOSTAT SET (K073493) | Vygon Corp. | 2008-05-06 |
| ENDOSCOPIC CLIP APPLIERS WITH CLIP MAGAZINE (K081031) | Aesculap, Inc. | 2008-05-05 |
| SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL LASER (K081181) | Cynosure, Inc. | 2008-05-05 |
| CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE (K080509) | Medtronic, Inc. | 2008-05-05 |
| AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE LINE REINFORCEMENT (K080898) | Tyco Healthcare Group LP | 2008-05-05 |
| LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM (K080158) | Lb Medical LLC | 2008-05-02 |
| PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK (K080093) | Gyrus Acmi, Inc. | 2008-05-02 |
| MOBLVAC W.C. (K081185) | Ohio Medical Corporation | 2008-05-02 |
| ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE (K080118) | Zeltiq Aesthetics | 2008-05-02 |
| DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT (K072930) | Demetech Corp. | 2008-04-30 |
| ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM (K080845) | Cardinalhealth | 2008-04-30 |
| WG-SURGICAL SUTURES WITH NEEDLE (K073614) | Foosin Medical Supplies, Inc. | 2008-04-30 |
| TRANSPOSAL ULTRA SYSTEMS (K081047) | Dornoch Medical Systems, Inc. | 2008-04-29 |
| IFS LASER SYSTEM (K073404) | Intra Lase Corp. | 2008-04-25 |