| STERI-LUB LUBRICATION GEL (K083189) | Avail Medical Products, Inc. | 2008-11-21 |
| AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5 (K082714) | Aalto Scientific, Ltd. | 2008-11-19 |
| SYNTHEMED DEVICE (K082276) | Synthemed, Inc. | 2008-11-18 |
| CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA (K080623) | Jas Diagnostics, Inc. | 2008-11-17 |
| MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE) (K082457) | Ansell Healthcare Products, Inc. | 2008-11-10 |
| AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5 (K082717) | Aalto Scientific, Ltd. | 2008-10-30 |
| BRAVORACER PEDIATRIC MANUAL WHEELCHAIR (K082314) | Otto Bock Healthcare LP | 2008-10-28 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K082597) | Tangshan Linyuan Plastic Products Co., Ltd. | 2008-10-24 |
| MODIFICATION TO ZENIEVA (K082865) | Gorbec Pharmaceutical Services, Inc. | 2008-10-23 |
| DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786 (K081382) | Duckworth & Kent, Ltd. | 2008-10-23 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K082822) | Zibo Zhuangyuan Plastic Products Company | 2008-10-22 |
| MEDLINE POWDER-FREE NITRILE EXAMINATION GLOVE WITH ALOE (K081594) | Medline Industries, Inc. | 2008-10-17 |
| POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (K082370) | Smart Glove Corp. Sdn Bhd | 2008-10-17 |
| CRYSTALSERT CRYSTALENS DELIVERY SYSTEM (K082944) | Bausch & Lomb, Inc. | 2008-10-16 |
| MRDH BANDAGE (K082703) | Marine Polymer Technologies, Inc. | 2008-10-14 |
| DISPOSABLE VINYL EXAMINATION GLOVE, POWDER FREE (K082447) | Rich Mountain Medical Products, Inc. | 2008-10-14 |
| JUMAO MANUAL WHEELCHAIR (K082784) | Danyang Jumao Healthcare Equipment Co., Ltd. | 2008-10-07 |
| RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS (K081478) | Bionostics, Inc. | 2008-10-06 |
| BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A (K082661) | Princeton BioMeditech Corp. | 2008-10-06 |
| ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 (K081545) | Advanced Medical Optics, Inc. | 2008-10-02 |
| DISPOSABLE VINYL EXAMINATION GLOVE, POWDERED (K082444) | Rich Mountain Medical Products, Inc. | 2008-09-30 |
| POWDER-FREE VINYL EXAMINATION GLOVES (K081658) | Jiangsu Alfa Glove Co., Ltd. | 2008-09-30 |
| OSSTELL ISQ IMPLANT STABILITY METER (K082523) | Osstell AB | 2008-09-26 |
| SYNTHETIC POWDER FREE (PINK) VINYL PATIENT EXAMINATION GLOVE (K082029) | Ever Light Plastic Products Co., Ltd. | 2008-09-26 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR (K081539) | Rich Mountain Medical Products, Inc. | 2008-09-26 |
| DISPOSABLE SYNTHETIC EXAMINATION GLOVES, POWDER FREE (K082443) | Rich Mountain Medical Products, Inc. | 2008-09-26 |
| GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002 (K082395) | Bionostics, Inc. | 2008-09-18 |
| CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2 (K082107) | Cliniqa Corporation | 2008-09-17 |
| NON-STERILE, POWDERED LATEX EXAMINATION GLOVE (K081910) | Siam Sempermed Corp., Ltd. | 2008-09-17 |
| YEAST TRAFFIC LIGHT PNA FISH (K080719) | Advandx, Inc. | 2008-09-12 |
| DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS (K081569) | Dynarex Corporation | 2008-09-12 |
| HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE (K080682) | Handpiece Headquarters, Inc. - Hpr, Inc. | 2008-09-11 |
| EYEFEEL OPHTHALMIC WARMER (K082087) | Bio-Lipid, Inc. | 2008-09-11 |
| DIGNITY 100 (K082246) | Dignity Medical Devices, Inc. | 2008-09-09 |
| LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK (K082036) | Bio-Rad Laboratories | 2008-09-08 |
| RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06 (K081455) | Rayner Surgical, Inc. | 2008-09-05 |
| SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS (K073478) | Sybron Dental Specialties, Inc. | 2008-09-03 |
| NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) (K081907) | Siam Sempermed Corp., Ltd. | 2008-09-03 |
| PERIMETRICS PERIOMETER (K072213) | Perimetrics, Inc. | 2008-08-29 |
| PLANMECA SOVEREIGN (K081699) | Planmeca USA, Inc. | 2008-08-29 |
| CENTURION PROTECTIVE RESTRAINT, SCR SERIES (K080448) | Tri-State Hospital Supply Corp. | 2008-08-28 |
| POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE (K081488) | Pt. Maja Agung Latexindo | 2008-08-28 |
| STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES (K081464) | Cardinalhealth | 2008-08-28 |
| SKINSENSE POLYISOPRENE UNDERGLOVE (K081180) | Molnlycke Health Care Us, LLC | 2008-08-26 |
| CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT MODEL ST-98 AND SATELLITE UNIT (K081237) | Craftmaster Contour Equipment, Inc. | 2008-08-25 |
| ELECSYS ANTI-TSHR CALCHECK (K080643) | Roche Diagnostics | 2008-08-22 |
| WESTAR SERIES DENTAL UNITS (K082294) | Westar Medical Products, Inc. | 2008-08-22 |
| MSC LIPID CONTROL (K082067) | Maine Standards Co. | 2008-08-22 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW) (K081657) | Jiangsu Cureguard Glove Co., Ltd. | 2008-08-20 |
| HAIDA MODEL HD11 MANUAL WHEELCHAIR (K082274) | Jiangyin East China Medical Technology Co., Ltd. | 2008-08-19 |
| VERISTA IMAGING ISOCAM II GAMMA CAMERA (K081757) | Verista Imaging, Inc. | 2008-08-15 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR (K081535) | Rich Mountain Medical Products, Inc. | 2008-08-14 |
| POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (PINK, BLACK, GREY, AND BLUE PEPPERMENT) (K081315) | Gx Corporation Sdn Bhd | 2008-08-11 |
| FDTX GLUCOSE CONTROL SOLUTION (K081915) | Fujirebio Diagnostics Texas, Inc. | 2008-08-08 |
| FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER (K073664) | Injectimed, Inc. | 2008-08-08 |
| AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION (K080273) | Fujirebio Diagnostics Texas, Inc. | 2008-08-08 |
| TCM ENDO 20 (K081191) | NOUVAG AG | 2008-08-07 |
| NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B (K071649) | Wallac OY | 2008-08-07 |
| ALATECH POWDERED LATEX PATIENT EXAMINATION GLOVE (K080606) | Alatech Healthcare, LLC | 2008-08-07 |
| PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M (K073381) | Focus Diagnostics, Inc. | 2008-08-04 |
| CARRIAZO-PENDULAR MICROKERATOME (K082043) | Schwind Eye-Tech-Solutions GmbH & Co. KG | 2008-08-01 |
| STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (K081466) | Smart Glove Corp. Sdn Bhd | 2008-07-30 |
| PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G (K073382) | Focus Diagnostics, Inc. | 2008-07-28 |
| ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR (K080848) | Q3 Innovations, LLC | 2008-07-25 |
| GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK (K081403) | Bionostics, Inc. | 2008-07-25 |
| ZENIEVA (K073246) | Gorbec Pharmaceutical Services, Inc. | 2008-07-23 |
| NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS (K063841) | Liposcience | 2008-07-23 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES (LIGHT YELLOW) (K081655) | Jiangsu Cureguard Glove Co., Ltd. | 2008-07-21 |
| SIALO DRAIN (K072334) | Sialo Technology, Ltd. | 2008-07-18 |
| APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201 (K080125) | Wako Chemicals USA, Inc. | 2008-07-18 |
| DIAZYME APOLIPOPROTEIN A-1 ASSAY (K072977) | General Atomics | 2008-07-16 |
| KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM (K081089) | Kimberly-Clark Corp. | 2008-07-14 |
| ICI P AND S SERIES IR CAMERAS (K073581) | Texas Infrared | 2008-07-11 |
| INSULIN PROTECTOR (K073555) | Medicool, Inc. | 2008-07-11 |
| CAPIMAGE (K081829) | Danish Diagnostic Development A/S | 2008-07-11 |
| AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY) (K081345) | Thermogenesis Corp. | 2008-07-10 |
| WATER WORKS DOUCHING DEVICE (K080200) | Abbott Research Group, Inc. | 2008-07-10 |
| ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT (K080739) | Abbott Molecular, Inc. | 2008-07-10 |
| KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES (K081260) | Kimberly-Clark Corp. | 2008-07-09 |
| DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE (K081300) | Siemens Healthcare Diagnostics | 2008-07-02 |
| KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE) (K081027) | Kimberly-Clark Corp. | 2008-06-30 |
| NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 (K073537) | Siemens Medical Solutions Diagnostics | 2008-06-27 |
| MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM (K081542) | Entellus Medical, Inc. | 2008-06-27 |
| MILLENIUM II (K081665) | Next Mobility, LLC | 2008-06-27 |
| VISUAL FOOTCARE TECHNOLOGIES TEMPSTAT (K080816) | Visual Footcare Technologies, LLC | 2008-06-24 |
| S40 CLINICAL ANALYZER, S TEST IP, S TEST UA (K072141) | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-24 |
| SMARTBURS (K080687) | S.S. White Burs, Inc. | 2008-06-20 |
| DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2 (K072985) | Duckworth & Kent, Ltd. | 2008-06-20 |
| MICRO-TOUCH NITRAFREE (K080536) | Ansell Healthcare Products, LLC | 2008-06-19 |
| ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) (K072560) | Teikoku Pharma USA, Inc. | 2008-06-17 |
| SWC/DWC WARMING CABINETS (K080609) | Mac Medical | 2008-06-13 |
| VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY (K080931) | bioMerieux, Inc. | 2008-06-11 |
| MARTIN CHAIR, MODEL C4S1 (K080506) | Martin Manufacturing Co., LLC | 2008-06-09 |
| COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE (K080677) | Kaltenbach & Voigt GmbH & Co. | 2008-06-06 |
| CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC (K080973) | Cliniqa Corporation | 2008-06-02 |
| CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER (K080631) | Oral Health Technologies, LLC | 2008-05-23 |
| POWDER FREE NITRILE EXAMINATION GLOVE, ORANGE (K080937) | Gx Corporation Sdn Bhd | 2008-05-23 |
| SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL (K073684) | Sheffield Industries, Div. of Faria , Ltd. | 2008-05-22 |
| NEUTROPHASE (K081009) | Novabay Pharmaceuticals | 2008-05-20 |
| POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE (K081040) | Pt.Shamrock Manufacturing Corp. | 2008-05-20 |