| SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA (K082470) | Inter-Med, Inc. | 2009-04-03 |
| ASAP WOUND DRESSING GEL (K082333) | American Biotech Labs | 2009-04-02 |
| NEOSALUS CREAM (K090585) | Quinnova Pharmaceuticals | 2009-04-02 |
| CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266 (K090026) | Hem Con Medical Technologies, Inc. | 2009-03-31 |
| HYLATOPIC EMOLLIENT FOAM (K083024) | Collegium Pharmaceutical Incorporated | 2009-03-27 |
| PRONTOSAN ANTIMICROBIAL WOUND GEL (K090141) | B.Braun Medical, Inc. | 2009-03-17 |
| SOFTSEAL-STF (K090100) | Chitogen, Inc. | 2009-03-11 |
| SILVER ALGINATE 11 WOUND DRESSING (K090453) | Advanced Medical Solutions Limited | 2009-02-26 |
| ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B (K083103) | Acrymed, Inc. | 2009-02-26 |
| COPA AMD (K082296) | Covidien Lp, Formerly Registered AS Tyco Healthcar | 2009-02-26 |
| ZEGRA POSTURE TRAINER (K081540) | Peter Fischer | 2009-02-20 |
| RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400 (K082921) | Rad Source Technologies, Inc. | 2009-02-17 |
| KERATEC WOUND DRESSINGS (K080949) | Keratec Limited | 2009-02-11 |
| PRO QR ADVANCED FORMULA POWDER (K080210) | Biolife, LLC | 2009-02-10 |
| CORRIDOR FIXATION SYSTEM (K083442) | Globus Medical, Inc. | 2009-02-06 |
| CRYOVALVE SG PULMONARY VALVE AND CONDUIT (K083106) | Cryolife, Inc. | 2009-02-06 |
| AWBAT-S, AWBAT-D, AWBAT-M (K082869) | Aubrey, Inc. | 2009-02-06 |
| GELX ORAL GEL (K081372) | Bmg Pharma, LLC | 2009-02-04 |
| PRUMYX CREAM (K082089) | Prugen, Inc. | 2009-01-13 |
| REPROCESSED HARMONIC SCALPEL (K083060) | Sterilmed, Inc. | 2009-01-09 |
| RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054 (K080431) | Quantrx Biomedical Corporation | 2009-01-08 |
| WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553 (K083355) | Blairex Laboratories, Inc. | 2008-12-29 |
| WOUND FLUSH, STERILE WATER & NORMAL SALINE (K083042) | Nurse Assist, Inc. | 2008-12-18 |
| HEMOSTASYL PASTE (K082116) | Satelec | 2008-12-17 |
| PRIMATRIX DERMAL REPAIR SCAFFOLD (K083440) | Tei Biosciences, Inc. | 2008-12-12 |
| SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT (K082795) | Interventional Spine, Inc. | 2008-12-12 |
| CUSTOM COMFORT NIGHTGUARD (K083400) | Den Tek Oral Care, Inc. | 2008-12-11 |
| INTEGRA MESHED BILAYER WOUND MATRIX (K081635) | Integra Lifesciences Corp. | 2008-12-04 |
| PROSIT WOUND TREATMENT DEVICE (K081977) | Silverleaf Medical Products, Inc. | 2008-12-01 |
| MODEL ES-130 (K081943) | Ito Co., Ltd. | 2008-11-24 |
| REXASTOM ORAL EASE (K082553) | Rexaderm, Inc. | 2008-11-21 |
| D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015 (K083190) | Vascular Solutions, Inc. | 2008-11-12 |
| BENACEL, MODELS C-001, C-002 AND C-005 (K080532) | Unicare Biomedical, Inc. | 2008-11-12 |
| SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING (K080503) | Advanced Medical Solutions Limited | 2008-11-12 |
| HYDROLYZED COLLAGEN WITH 10% CHONDROITIN SULFATE (PSGAG, POLYSULFATED GLYCOSAMINOGLYCAN) WOUND GEL (K081724) | Applied Nutritionals | 2008-10-30 |
| X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER (K080944) | C.R. Bard, Inc. | 2008-10-23 |
| CARAPASTE ORAL WOUND DRESSING (K082856) | Mcgrath Pharmaceuticals, Inc. | 2008-10-15 |
| PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION (K082330) | Primary Care Solutions, Inc. | 2008-10-09 |
| UltraClot, UltraClot OTC (K082601) | Emergency Medical Devices, LLC | 2008-10-09 |
| LTM WOUND DRESSING (K082103) | Lifecell Corp. | 2008-10-08 |
| GRIND NO MORE (K082301) | Placontrol, Inc. | 2008-10-06 |
| COLLIEVA (K081782) | Innocoll Pharmaceuticals | 2008-09-30 |
| OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTENE & CERETENE (K082491) | Ceremed , Inc. | 2008-09-24 |
| NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING (K081363) | Advanced Medical Solutions Limited | 2008-09-24 |
| ACRYDERM ABSORBENT OXYGEN DRESSING (K082459) | Acrymed, Inc. | 2008-09-19 |
| DIZZYFIX (K081602) | Clearwater Clinical Limited | 2008-09-19 |
| SILVERMED ANTIMICROBIAL SILVER HYDROGEL (K073019) | Argentis Biomedical Incorporated | 2008-09-16 |
| NEOSALUS (K070309) | Quinnova Pharmaceuticals | 2008-09-12 |
| SILVER ANTIMICROBIAL WOUND GEL (K073197) | Advanced Medical Solutions Limited | 2008-08-28 |
| MAX ADJUSTING INSTRUMENT (K082218) | Manna Omni International, Inc. | 2008-08-13 |
| CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM (K081459) | Integra Radionics, Inc. | 2008-08-13 |
| MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC (K072486) | Hem Con Medical Technologies, Inc. | 2008-08-06 |
| IMPROVED COMFORT-FIT NIGHTGUARD (K081669) | Den Tek Oral Care, Inc. | 2008-07-10 |
| MEDTRADE PRODUCTS CELOX HEMOSTATIC GRANULES ON SHEET (K080097) | Medtrade Products , Ltd. | 2008-07-09 |
| STRESSGARD NIGHTGUARD (K072968) | Totalgard Corporation | 2008-07-01 |
| DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILVER (ALGICELL AG) (K080497) | Derma Sciences Canada, Inc. | 2008-06-27 |
| EPLEY OMNIAX (K071973) | Vesticon | 2008-06-20 |
| DERMA SCIENCES OTC MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY (K081584) | Derma Sciences, Inc. | 2008-06-19 |
| PRONTOSAN WOUND IRRIGATION SOLUTION (K072876) | B.Braun Medical, Inc. | 2008-06-19 |
| WOUNDSTAT (K081183) | Traumacure, Inc. | 2008-06-19 |
| SURESKIN SILVER BANDAGES (K081274) | Euromed, Inc. | 2008-05-28 |
| THERABOND ANTIMICROBIAL BARRIER SYSTEMS (K073213) | Choice Therapeutics | 2008-05-28 |
| SONOCA 180/195 WOUND CARE SYSTEM (K072904) | Soering GmbH | 2008-05-21 |
| MODIFICATION TO 3M TEGADERM CHG DRESSING (K080620) | 3M Company-3M Health Care | 2008-05-19 |
| HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING (K080818) | Hem Con Medical Technologies, Inc. | 2008-05-15 |
| MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM (K072251) | Merete Medical GmbH | 2008-05-08 |
| TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE (K080648) | Ore-Medix, LLC | 2008-05-07 |
| REVERA WOUND CARE, MODEL MDW0060 (K070463) | Revalesio Corporation | 2008-05-07 |
| AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING (K080383) | Convatec, A Division of E.R. Squibb & Sons, LLC | 2008-05-02 |
| SUPRASORB A +AG (K071442) | Specialty Fibres and Materials, Ltd. | 2008-05-01 |
| PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING (K071552) | Medline Industries, Inc. | 2008-04-25 |
| DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY (K080315) | Derma Sciences, Inc. | 2008-04-23 |
| ANASEPT ANTIMICROBIAL SKIN AND WOUND CLEANSERS; ANASEPT ANTIMICROBIAL SKIN AND WOUND GEL (K073547) | Anacapa Technologies, Inc. | 2008-04-23 |
| ELTA ADVANCED WOUND WASH (K073610) | Swiss American Products, Inc. | 2008-04-23 |
| IMPULSE IQ ADJUSTING INSTRUMENT (K080261) | Neuromechanical Innovations, LLC | 2008-04-11 |
| CRYOSTAT (K072414) | Lil Drug Store Products, Inc. | 2008-04-07 |
| TETRIX CREAM (K071483) | Coria Laboratories, Ltd. | 2008-04-04 |
| NOCC HYDROPHILIC WOUND DRESSING (K080010) | Kytogenics, Inc. | 2008-03-14 |
| EARPOPPER, MODEL EP-2000, EP-2100, EP-3000 (K073401) | Micromedics, Inc. | 2008-03-14 |
| TRANS1 FACET SCREW (K073515) | Trans1 Incorporated | 2008-03-11 |
| APX21 (K073185) | Techdent Technologies, Ltd. | 2008-03-06 |
| RADIO BIOAQUACARE (K080471) | Bioartificial Gel Technologies (Bagtech), Inc. | 2008-03-05 |
| APEX DAL ELECTRONIC APEX LOCATOR (K080113) | Medicnrg , Ltd. | 2008-02-15 |
| GRIND GUARD (K073446) | Archtek, Inc. | 2008-02-08 |
| COLLAWOUND HYDROGEL (K071557) | Collamatrix Co., Inc. | 2008-02-08 |
| HUMAN HEART VALVE, CRYOVALVE SG (K033484) | Cryolife, Inc. | 2008-02-07 |
| CHAMELEON FIXATION SYSTEM (K071420) | Spinefrontier, Inc. | 2008-01-16 |
| BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE, BLISTER PACKAGED OR IN PLASTIC BAG CONTAINERS (K072068) | Bioartificial Gel Technologies (Bagtech), Inc. | 2007-12-21 |
| MEDTRADE PRODUCTS CELOX SOLBAG, ANTI - COAGULANT (K072328) | Medtrade Products , Ltd. | 2007-12-21 |
| LIFE4C (K063304) | Numedis, Inc. | 2007-12-21 |
| THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT (K073220) | Prestige Brands, Inc. | 2007-12-19 |
| HYALOMATRIX PA (K073251) | Fidia Advanced Biopolymers Srl | 2007-12-14 |
| EDTA PLUS (K072555) | Essential Dental Systems, Inc. | 2007-12-13 |
| STASILON FR (K072890) | Entegrion, Inc. | 2007-12-10 |
| HEMAWAY SEAT (K072690) | Hemaway, LLC | 2007-12-07 |
| D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005 (K073264) | Vascular Solutions, Inc. | 2007-12-07 |
| COPA AMD ANTIMICROBIAL WOUND DRESSING (K071371) | Tyco Healthcare Group LP | 2007-11-19 |
| THERMOFORM SHEET MATERIALS AND ACCESSORIES (K072522) | Dentsply International, Inc. | 2007-11-16 |
| BIOXTRA MOISTURIZING GEL (K072306) | Bio-X Healthcare S.A. | 2007-11-15 |
| PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626 (K072378) | Arthrex, Inc. | 2007-11-09 |