| TANSCU O2 (K090681) | Electrochemical Oxygen Concepts, Inc. | 2009-08-12 |
| OMNISURE URETHRAL SLING, MODEL OTK52 (K092203) | Mpathy Medical Devices, Ltd. | 2009-08-12 |
| MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400 (K091357) | Kimberly-Clark Corp. | 2009-08-10 |
| UC-CARE WARMING SYSTEM (K090978) | UC-CARE , Ltd. | 2009-08-10 |
| BOVIE ICON GS ELECTROSURGICAL GENERATOR (GS100), HANDPIECE (GS-OP-R), REUSABLE HANDPIECE CABLE (GS807-RC) (K090586) | Bovie Medical | 2009-08-07 |
| TEPHAFLEX SURGICAL FILM (K091633) | Tepha, Inc. | 2009-08-07 |
| SNAP WOUND CARE DEVICE (DEN080011) | Spiracur, Inc. | 2009-08-07 |
| BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732 (K091659) | C.R. Bard, Inc. | 2009-08-03 |
| SOFTLASE PRO, ORTHOLASE AND HYGIENELASE (K091796) | Zap Lasers, LLC | 2009-07-31 |
| MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN (K091178) | Mtp Medical Technical Promotion GmbH | 2009-07-31 |
| IMAGINE TC SKIN THERAPY SYSTEM (K083461) | Endymion Medical, Ltd. | 2009-07-24 |
| FLORASEAL, MODEL FS350D (K083354) | Adhezion Biomedical | 2009-07-20 |
| ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE (K091900) | Covidien Lp, Formerly Registered AS United States | 2009-07-16 |
| PASCAL PHOTOCOAGULATOR, PASCAL-US (K091666) | Optimedica Corporation | 2009-07-15 |
| WATERLASE C100, MODEL 7100104 (K091922) | Biolase Technology, Inc. | 2009-07-14 |
| MINITAPE URETHRAL SLING (K091180) | Mpathy Medical Devices, Ltd. | 2009-07-14 |
| COOK UROLOGICAL GRAFT (K090688) | Cook Biotech, Inc. | 2009-07-10 |
| LITHO LASER SYSTEM (K091909) | Quanta System Spa | 2009-07-09 |
| RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 66800059 (K091470) | Smith & Nephew, Inc. | 2009-07-09 |
| REACTION SYSTEM (K090221) | Viora , Ltd. | 2009-07-01 |
| ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD (K081923) | Glaxosmithkline Consumer Healthcare | 2009-07-01 |
| ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM (K091816) | Boston Scientific Corporation | 2009-07-01 |
| FOTONA XP ND: YAG LASER SYSTEM FAMILY, FOTONA XP, XP-2 FOCUS, FOTONA XP CHANGER,MODEL MOO1-14F, MOO1-14F, MOO1-14F/2, (K090126) | Fotona D.D. | 2009-06-29 |
| CERALAS MULTIWAVELENGTH 980/1470NM DIODE LASER (K090164) | Biolitec, Inc. | 2009-06-26 |
| WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730 (K091510) | Boston Scientific Corporation | 2009-06-26 |
| THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES (K090580) | Solta Medical, Inc. | 2009-06-26 |
| CODMAN ISOCOOL BIPOLAR FORCEPS (K083895) | Codman & Shurtleff, Inc. | 2009-06-23 |
| ARTHROCARE SYSTEM 15000 CONTOLLER, MODEL 72202149, ARTHROCARE ARTHROWANDS, MODEL 72202139,72202141, 72202143, 72202144 (K090393) | Arthrocare Corp. | 2009-06-23 |
| CYBER SURGICAL LASER FAMILY INCLUDING: CYBER TM, CYBER GREEN, CYBER GREEN TM (K090962) | Quanta System Spa | 2009-06-19 |
| VARI-LASE PLATINUM BRIGHT TIP LASER FIBER (K091551) | Vascular Solutions, Inc. | 2009-06-19 |
| AS 1000 ULTRASOUND WOUND THERAPY SYSTEM (K091038) | Arobella Medical, LLC | 2009-06-19 |
| ARAGON SURGICAL RF SYSTEM L2 INSTRUMENT (K090306) | Aragon Surgical, Inc. | 2009-06-18 |
| STRATAPULSE TS AND STRATAPULSE (K090837) | Advanced Medical Photonics | 2009-06-17 |
| CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205 (K090721) | Medtronic | 2009-06-16 |
| VEINWAVE, TC3000 (K083352) | Newlands Clinical Trials, Ltd. | 2009-06-12 |
| KLS MARTIN ELECTROSURGICAL INSTRUMENTS (K082505) | Kl Martin L.P. | 2009-06-12 |
| PATHOLASE FAMILY OF PINPOINTE AND PINPOINTE FOOTLASER ND: YAG LASERS (K083616) | Patholase, Inc. | 2009-06-12 |
| XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01 (K091432) | Anulex Technologies, Inc. | 2009-06-12 |
| CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L (K090821) | Frankenman International Limited | 2009-06-10 |
| TRIOS SYSTEM (K090399) | Viora , Ltd. | 2009-06-10 |
| PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE (K083415) | Peak Surgical, Inc. | 2009-06-05 |
| MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200) (K091323) | Intermedic Arfran, SA | 2009-06-04 |
| C-QUR V -PATCH MESH (K090909) | Atrium Medical Corp. | 2009-06-04 |
| PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM (K090934) | American Medical Systems, Inc. | 2009-06-02 |
| NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION) (K090630) | Nobel Biocare AB | 2009-06-02 |
| MEGAPULSE LASER SYSTEM AND FIBERS (K090776) | Richard Wolf Medical Instruments Corp. | 2009-06-02 |
| LOI SYSTEM (K090525) | Palomar Medical Products, Inc. | 2009-06-01 |
| CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G (K091322) | Ethicon Endo-Surgery, Inc. | 2009-06-01 |
| REVLITE Q-SWITCHED ND:YAG LASER SYSTEM (K083899) | Hoya Conbio, Inc. | 2009-06-01 |
| TANTHERA-T35 (K090831) | Tanthera, Inc. | 2009-05-29 |
| SRI LEVEL II SURGICAL GOWN (K090383) | Sri Surgical | 2009-05-29 |
| XYLOS POROUS SURGICAL MESH (K090880) | Xylos Corporation | 2009-05-27 |
| PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501 (K091097) | Promedical Products Co., Ltd. | 2009-05-27 |
| ZELTIQ SYSTEM (K090094) | Zeltiq Aesthetics | 2009-05-20 |
| APLION TOPICAL CARE SYSTEM (K091133) | Aplion Medical,Llc | 2009-05-20 |
| INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT (K091215) | Power Medical Interventions, Inc. | 2009-05-18 |
| LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE, MODEL ZLK-100 (K083455) | Medi-Khan USA, Inc. | 2009-05-18 |
| POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVE (K090066) | Wear Safe (Malaysia) Sdn. Bhd. | 2009-05-15 |
| LOTUS II PULSED ER: YAG LASER SYSTEM (K083253) | Laseroptek Co., Ltd. | 2009-05-15 |
| ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026 (K090489) | Kci USA, Inc. | 2009-05-14 |
| ELITE MPX LASER SYSTEM WITH CRYO C (K091169) | Cynosure, Inc. | 2009-05-13 |
| REFINE LIFT SYSTEM (K083102) | Alure Medical, Inc. | 2009-05-11 |
| VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020 (K091152) | Coloplast A/S | 2009-05-07 |
| ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC (K082834) | Ellman Int'L, Inc. | 2009-05-07 |
| LARIAT II SUTURE DELIVERY DEVICE (K090385) | Sentreheart, Inc. | 2009-05-06 |
| PARIETEX MONOFILAMENT POLYESTER MESH (K090858) | Sofradim Production | 2009-05-06 |
| ORTHADAPT PR (K090288) | Pegasus Biologics, Inc. | 2009-05-05 |
| CONMED AER DEFENSE SMOKE EVACUATOR (K091139) | Conmed Corporation | 2009-05-05 |
| LUME 2 SYSTEM, MODEL GA0005000 (K083733) | Lumenis, Ltd. | 2009-05-04 |
| COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE (K091016) | Surgical Devices, A Global Business Unit Covidien | 2009-05-04 |
| MONTERIS MEDICAL AUTOLITT LASER PROBE (K081509) | Monteris Medical, | 2009-05-01 |
| MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM (K091107) | Hemostatix Medical Technologies, LLC | 2009-05-01 |
| GENADYNE A4-XLR8 WOUND VACUUM SYSTEM (K090638) | Genadyne Biotechnologies, Inc. | 2009-04-29 |
| CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001 (K091017) | Cardica, Inc. | 2009-04-29 |
| MTA PROTECTIVE SHEET (K090778) | Xylos Corporation | 2009-04-28 |
| HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM (K083203) | Laseroptek Co., Ltd. | 2009-04-28 |
| DS N95 SURGICAL MASKS AND FLAT SURGICAL (K090131) | Shanghai Dasheng Health Products | 2009-04-27 |
| SKLAR SURGICAL GOWN (K082479) | Sklar Corp. | 2009-04-24 |
| REBOUND HRDV (K083467) | Minnesota Medical Development, Inc. | 2009-04-23 |
| FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY (K083889) | Fotona D.D. | 2009-04-23 |
| INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM (K090070) | Invuity, Inc. | 2009-04-22 |
| MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE (K091087) | Surgical Devices, Tyco Healthcare Group LP | 2009-04-22 |
| PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER) (K091011) | Surgical Technology Laboratories, Inc ("Stl") | 2009-04-22 |
| MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM (K090872) | Cardica, Inc. | 2009-04-21 |
| ISKRA MEDICAL GREEN IRF PRESTIGE (K083590) | Iskra Medical, D.O.O. | 2009-04-17 |
| VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM (K090679) | Vioptix, Inc. | 2009-04-17 |
| ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORM (K083848) | Alma Lasers , Ltd. | 2009-04-14 |
| CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C (K090618) | Cynosure, Inc. | 2009-04-14 |
| BLUESHINE GOLD SERIES (K090297) | Blueshine Srl | 2009-04-14 |
| AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS (K083519) | Covidien Lp, Formerly Registered AS United States | 2009-04-10 |
| INCISIVE FAMILY OF INPULSE ND:YAG LASERS (K083215) | Incisive, LLC | 2009-04-08 |
| ATMOS S041 WOUND (K090130) | Atmos, Inc. | 2009-04-02 |
| BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM (K090759) | Biodrain Medical, Inc. | 2009-04-01 |
| COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY (K090410) | New Star Lasers, Inc. | 2009-03-27 |
| SYNTHASOME X-REPAIR (K083307) | Synthasome, Inc. | 2009-03-27 |
| GORE BIO-A FISTULA PLUG (K083266) | W. L. Gore & Associates, Inc. | 2009-03-27 |
| V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE (K082662) | Surgical Devices, Tyco Healthcare Group LP | 2009-03-26 |
| KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100 (K083234) | Kimberly-Clark Corp. | 2009-03-25 |
| MYOSCIENCE CRYO-TOUCH (K083493) | Myoscience, Inc. | 2009-03-20 |
| DERMATOLOGIC TREATMENT SYSTEM (DTS) G2 (K082819) | Miramar Labs, Inc. | 2009-03-20 |