| CLEARSPLINT ES (K111828) | Astron Dental Corporation | 2011-10-26 |
| SKAFFOLD CIS (K111538) | Skeletal Kinetics, LLC | 2011-10-25 |
| ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN (K111904) | Ark Diagnostics, Inc. | 2011-10-18 |
| SULCUS BLUE (K111978) | Produits Dentaires Pierre Rolland | 2011-10-13 |
| EXCELLAGEN (K110318) | Tissue Repair Company | 2011-10-03 |
| CORELEADER COLLA-ALGI FIBER MODEL CAW (K111578) | Coreleader Biotech Co., Ltd. | 2011-09-23 |
| COLLAGEN POWDER (K103648) | Innocoll Pharmaceuticals, Ltd. | 2011-09-14 |
| EPISIL (K101769) | Camurus AB | 2011-09-13 |
| UNITE BIOMATRIX (K112399) | Synovis Orthopedic & Woundcare | 2011-09-07 |
| CORELEADER HEMO-PAD MODEL CPII 02030 (K102944) | Coreleader Biotech Co., Ltd. | 2011-09-07 |
| MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG (K110062) | Medipurpose Pte. , Ltd. | 2011-09-01 |
| MATRISTEM WOUND MATRIX (K112409) | Acell, Inc. | 2011-08-29 |
| INTEGRA(TM) CUSA NXT(TM) BONE TIPS (K111741) | Integra Burlington Ma, Inc. (Formerly Integra Radi | 2011-08-23 |
| TL-CERMIDE SKIN BARRIER EMULSION (K110757) | Trigen Laboratories, Inc. | 2011-08-19 |
| SONAFINE WOUND DRESSING (K110172) | Stratus Pharmaceutical | 2011-08-19 |
| COLLACARE DENTAL (K110388) | Innocoll Pharmaceuticals, Ltd. | 2011-08-09 |
| FREEWAY COMFORT BITE GUARD (K110468) | Randmark Dental Products, LLC | 2011-08-05 |
| MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY (K110546) | Derma Sciences, Inc. | 2011-07-27 |
| ADVANCIS ACTIVON TUBE (K101114) | Advancis Medical | 2011-07-26 |
| RE / STASIS (TM) GINGIVAL RETRACTION PASTE (K111348) | Centrix, Inc. | 2011-07-22 |
| MP 719 (K111524) | Marine Polymer Technologies, Inc. | 2011-07-22 |
| BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF (K103745) | Glaxosmithkline Consumer Healthcare (Gskch) | 2011-07-20 |
| CORELEADER ALGIPLASTER MODEL AP 050501 (K102942) | Coreleader Biotech Co., Ltd. | 2011-06-22 |
| ELTA WOUND CLEANSER (K103713) | Swiss American Products, Inc. | 2011-06-16 |
| GUARDACARE (K103641) | Hem Con Medical Technologies, Inc. | 2011-06-16 |
| CUSA NXT EXTENDED LENGTH TIP (K102258) | Integra Radionics, Inc. | 2011-06-10 |
| EMULSION SB (K110732) | Prugen IP Holdings, Inc. | 2011-06-03 |
| CORELEADER COLLA-PAD MODEL CS 03030 (K102946) | Coreleader Biotech Co., Ltd. | 2011-05-20 |
| EXSALT SD7 WOUND DRESSING (K103067) | Exciton Technologies, Inc. | 2011-05-20 |
| SYNTHES HEMOSTATIC BONE PUTTY (HBP) (K103822) | Synthes USA Products, LLC | 2011-05-19 |
| CHITOGAUZE FUSION (K111163) | Hem Con Medical Technologies, Inc. | 2011-05-17 |
| CELOX RAPID GAUZE (K110386) | Medtrade Products , Ltd. | 2011-05-10 |
| DURAFIBER AG (K103793) | Smith & Nephew, Inc. | 2011-05-02 |
| PERIOPATCH (K110750) | Mis Implants Technologies , Ltd. | 2011-04-28 |
| CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050 (K102943) | Coreleader Biotech Co., Ltd. | 2011-04-12 |
| PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT WRIST STRIP (K110563) | Therapeutics 101, Inc (Dba Pressure Point, Inc.) | 2011-04-08 |
| D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER (K102212) | Vascular Solutions, Inc. | 2011-04-08 |
| XEROS DRY MOUTH PUMP (K110116) | Lorin Technologies Corporation | 2011-04-08 |
| THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY (K101746) | Microgenics Corp. | 2011-04-08 |
| PRONTOSAN WOUND IRRIGATION SOLUTION (K110744) | B.Braun Medical, Inc. | 2011-04-06 |
| HYLATOPICPLUS CREAM (K110727) | Precision Dermatology Incorporated | 2011-04-01 |
| CHLORASHIELD TM ANTIMICROBIAL DRESSING (K103106) | Care Fusion 213, LLC | 2011-03-30 |
| MANUKATEX (K110042) | Manuka Medical Limited | 2011-03-24 |
| CELSTAT (K103245) | Baxter Healthcare Corp | 2011-03-23 |
| SILVER ANTIMICROBIAL WOUND GEL (K110458) | Advanced Medical Solutions Limited | 2011-03-14 |
| APEX POINTER+; MEASRUING CABLE, HOOK, LIP CLIP, TOUCH PROBE (ACCESSORIES) (K103123) | Micro-Mega Societe Anonyme | 2011-03-10 |
| SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION T (K101797) | Covidien, Formerly Valleylab, A Division of Tyco | 2011-02-24 |
| MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY (K101793) | Derma Sciences, Inc. | 2011-02-22 |
| ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR (K102762) | Orthocon, Inc. | 2011-02-15 |
| QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION (K103244) | Dentsply Intl., Inc. | 2011-02-14 |
| PERIOPATCH (K103054) | Izun Pharmaceuticals Corporation | 2011-02-07 |
| PEDIACYN ATOPIC DERMATITIS HYDROGEL (K102945) | Oculus Innovative Sciences, Inc. | 2011-02-02 |
| SURGIAID (K100927) | Maxigen Biotech, Inc. | 2011-02-02 |
| NASAL CEASE (K102742) | Catalina, Inc. | 2011-02-02 |
| HYPO CLENZ WOUND WASH MODEL 100 PPM (K100948) | Nevoa Life Sciences, LLC | 2011-02-02 |
| GC ORAL MOISTURIZING GEL (K101346) | GC America, Inc. | 2011-01-27 |
| ORAL FLUID PHENCYCLIDINE (K093989) | Roche Diagnostics | 2011-01-25 |
| SORBACT (K100591) | Abigo Medical AB | 2011-01-24 |
| LOW ADHERENT AFM AG DRESSINGS (K103141) | Milliken Healthcare Products, LLC | 2011-01-21 |
| BIOMED WOUND CLEANSER (K100613) | Biomed Laboratories, Inc. | 2011-01-05 |
| NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABS (K102806) | Allergan Medical | 2011-01-05 |
| NYDIAG 200 (K102364) | Interacoustics A/S | 2010-12-23 |
| THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY (K102549) | Ascension Orthopedics, Inc. | 2010-12-21 |
| ACTIVON TULLE (K101118) | Calidad Solutions, Inc. | 2010-12-15 |
| PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD (K100261) | Tei Biosciences, Inc. | 2010-12-10 |
| CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI (K102965) | Medtrade Products , Ltd. | 2010-12-08 |
| MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER (K102659) | Manuka Medical Limited | 2010-12-08 |
| NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE (K102459) | Hemostasis, LLC | 2010-12-03 |
| SPECTRA OPTIA R APHERESIS SYSTEM (K103090) | Caridianbct, Inc.. | 2010-11-19 |
| I-ROOT (K100450) | S-Denti Co., Ltd. | 2010-11-18 |
| CHITOGAUZE (K102546) | Hem Con Medical Technologies, Inc. | 2010-11-17 |
| VIPER F2 FACET FIXATION SYSTEM (K101762) | Depuy Spine, Inc. | 2010-11-15 |
| PRONTOSAN ANTIMICROBIAL WOUND GEL (K101882) | B.Braun Medical, Inc. | 2010-11-03 |
| OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING (K102478) | Southwest Technologies, Inc. | 2010-11-03 |
| COLLEXA (K100574) | Innocoll Pharmaceuticals | 2010-10-28 |
| TSC (K101756) | Kerr Corporation | 2010-10-26 |
| KYPHON ANCHOR FACET SCREW SYSTEM (K101765) | Medtronic Spine, LLC | 2010-10-22 |
| EXSALT WOUND DRESSING (K100580) | Exciton Technologies, Inc. | 2010-10-12 |
| APEXNRG RIDER (K101177) | Medicnrg , Ltd. | 2010-10-08 |
| OSTENE CT, AOC CT, OSTEOTENE, CERETENE (K102071) | Ceremed , Inc. | 2010-10-08 |
| GIRAFFE2 (K102133) | Kerr Corporation | 2010-10-07 |
| PRIMALOK FACET FIXATION SYSTEM (K102438) | Osteomed LP | 2010-09-30 |
| BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH (K101477) | Glaxosmithkline Consumer Healthcare (Gskch) | 2010-09-28 |
| CALGAESEAL MODEL: CAS (K101097) | Bz Medical, Inc. | 2010-09-22 |
| MEPILEX BORDER AG DRESSING (K100029) | Molnlycke Health Care | 2010-09-15 |
| ROMIAPEX MODEL A-15 (K101054) | Romidan, Ltd. | 2010-09-03 |
| TX1 TISSUE REMOVAL SYSTEM (K101561) | American Optisurgical, Inc. | 2010-08-27 |
| LANX FACET SCREW SYSTEM (K101364) | Lanx, Inc. | 2010-08-16 |
| POSTURETEK (K093553) | Perseus Althetics,Llc | 2010-08-13 |
| AQUANOVA AG SUPER ABSORBANT DRESSING, AQUANOVA AG ANTIMICROBIAL DRESSING (K100693) | Medtrade Products Limited | 2010-08-10 |
| VASHE WOUND THERAPY SYSTEM MODEL: 9000-0014 (K100918) | Puricore, Inc. | 2010-08-09 |
| MULTI-PURPOSE HEALTH DEVICE (K093322) | Upc Medical Supplies, Inc. Dba United Pacific Co. | 2010-08-05 |
| TALYMED (K102002) | Marine Polymer Technologies | 2010-07-28 |
| FACET SCREW SYSTEM (K101284) | Nuvasive, Inc. | 2010-07-15 |
| OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE (K101059) | Omega Laboratories, Inc. | 2010-07-12 |
| PR CREAM (K093159) | Prugen IP Holdings, Inc. | 2010-06-24 |
| PRUCLAIR NONSTEROIDAL CREAM (K093156) | Prugen IP Holdings, Inc. | 2010-06-24 |
| ENDOFORM DENTAL TEMPLATE (K101546) | Mesynthes, Ltd. | 2010-06-23 |
| DRYODINE CADEXOMER-IODINE GEL (K093320) | Collegium Pharmaceutical Incorporated | 2010-06-18 |
| COLLAWOUND ART (K093351) | Collamatrix, Inc. | 2010-06-16 |