| IND URINARY TRACT INFECTION (UTI) TEST STRIPS (K103037) | Ind Diagnostic, Inc. | 2012-04-17 |
| MECHANICAL WHEELCHAIR (K120032) | Aikin Healthcare Co., Ltd. | 2012-04-13 |
| STERILE LUBRICATING JELLY (K112110) | Jianerkang Medical Dressing Company | 2012-04-10 |
| PIXEL APP (K120473) | Gauss Surgical, Inc., | 2012-04-09 |
| ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS (K112653) | ACON Laboratories, Inc. | 2012-04-09 |
| SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT (K113674) | Handpiece Headquarters, Inc. - Hpr, Inc. | 2012-04-05 |
| TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE (K110481) | Asi Medical, Inc. | 2012-04-05 |
| SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT (K113433) | Focus Diagnostics, Inc. | 2012-04-04 |
| REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM (K111636) | Gunnell, Inc. | 2012-04-03 |
| STAPHYLOCOCCUS QUICKFISH BC (K113371) | Advandx, Inc. | 2012-04-03 |
| DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR (K120190) | Rich Mountain Medical Products, Inc. | 2012-04-02 |
| PATHASSIT LIGHT SEEKER (K120735) | Entellus Medical, Inc. | 2012-04-02 |
| KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT (K120563) | Microphage, Inc. | 2012-03-30 |
| ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT (K112538) | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-03-29 |
| POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM (K113233) | Shen Wei (Usa), Inc. | 2012-03-29 |
| JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR (K112948) | Jiangsu Healthy Way Medical Equipment Co;Ltd | 2012-03-28 |
| JIANGSU HEALTHY WAY MECHANICL WHEELCHAIR (K112950) | Jiangsu Healthy Medical Equipment Co;Ltd | 2012-03-28 |
| MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4) (K112977) | Alcon Research, Ltd. | 2012-03-27 |
| LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK (K120504) | Bio-Rad Laboratories, Inc. | 2012-03-27 |
| NON-STERILE, POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K112005) | Ug Healthcare (Usa), Inc. | 2012-03-21 |
| POSEY BED (K113357) | J. T. Posey Co. | 2012-03-21 |
| NON-STERILE, POWDER-FREE BLUE, NITRILE EXAMINATION GLOVES (K112012) | Ug Healthcare (Usa), Inc. | 2012-03-21 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K110536) | Zibo Tengyue Plastic Products Co., Ltd. | 2012-03-19 |
| ENDO-EXPRESS (R) HANDPIECE (K111541) | Essential Dental Systems, Inc. | 2012-03-16 |
| BD BACTEC Plus Aerobic/F Culture Vials (plastic) (K113558) | Becton, Dickinson and Company | 2012-03-16 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR (K113749) | Full Synergy Medical Products, Inc. | 2012-03-15 |
| POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM (K102189) | Latexx Manufacturing Sdn.Bhd. | 2012-03-14 |
| KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE (K113423) | Kimberly-Clark Corp. | 2012-03-09 |
| YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR (K120526) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2012-03-08 |
| NEO NEST (K112547) | Denovo Proucts, LLC | 2012-03-06 |
| DISPOSABLE VINYL EXAM GLOVE, POWDERED (K113790) | Full Synergy Medical Products, Inc. | 2012-03-06 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K120358) | Hongxin Plastic Products Co., Ltd. | 2012-03-06 |
| DISPOSABLE POWDER FREE VINYL EXAM GLOVE, WHITE COLOR (K113750) | Full Synergy Medical Products, Inc. | 2012-03-05 |
| TI-MAX X TURBINE (K113655) | Nakanishi, Inc. | 2012-03-05 |
| HELICOBACTER PYLORI ELISA IGG TEST KIT (K110745) | Gold Standard Diagnostics | 2012-03-02 |
| DISPOSABLE VINYL EXAM GLOVE, POWDER FREE (K113797) | Full Synergy Medical Products, Inc. | 2012-03-02 |
| AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY (K111964) | Aalto Scientific, Ltd. | 2012-03-02 |
| TRANSPORT CULTURE MEDIUM DEVICE (K113249) | Puritan Medical Products, LLC | 2012-03-01 |
| BIONIME DIABETES MANAGEMENT SYSTEM VI.0 (K113007) | Bionime Corporation | 2012-02-27 |
| ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE (K113222) | Nakamura Dental Handpiece Mfg. Co., Ltd. | 2012-02-23 |
| POWDERFREE POLYISOPRENE SURGICAL GLOVES (K112654) | Pt. Medisafe Technologies | 2012-02-17 |
| BD MAX GBS ASSAY, BD MAX INSTRUMENT (K111860) | Becton, Dickinson & CO | 2012-02-16 |
| CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900 (K110278) | Nakanishi, Inc. | 2012-02-15 |
| IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL... (K111938) | Immunodiagnostic Systems , Ltd. | 2012-02-14 |
| DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR (K113710) | Full Synergy Medical Products, Inc. | 2012-02-14 |
| DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR (K113722) | Full Synergy Medical Products, Inc. | 2012-02-14 |
| NOTOUCH BREASTSCAN (K113259) | Ue Lifesciences, Inc. | 2012-02-10 |
| ORTHOSLENDERIZER (K111249) | Orthomatics, Inc. | 2012-02-08 |
| PROPHY-MATE NEO (K112673) | Nakanishi, Inc. | 2012-02-07 |
| POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K113100) | Maxter Glove Manufacturing Sdn Bhd | 2012-02-06 |
| NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM (K112976) | Hartalega Snd. Bhd. | 2012-02-02 |
| GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT (K110899) | Gold Standard Diagnostics | 2012-02-01 |
| AUDIT MICROCV T-UPTAKE LINEARITY (K112143) | Aalto Scientific, Ltd. | 2012-01-31 |
| BIOGEL (R) INDICATOR (R) UNDERGLOVE (K111413) | Molnlycke Health Care Us, LLC | 2012-01-30 |
| GLUCOSE METER-CHECK SOLUTION FOR INFOPIA (K113764) | Bionostics, Inc. | 2012-01-30 |
| VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT (K113524) | Maine Standards Co. | 2012-01-27 |
| PATHASSIST LIGHT SEEKER (K113522) | Entellus Medical, Inc. | 2012-01-27 |
| NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K111134) | Siem Aempemed Corp., Ltd. | 2012-01-26 |
| COBAS 4800 CT / NG TEST (K110923) | Roche Molecular Systems, Inc. | 2012-01-24 |
| AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL (K112705) | Aalto Scientific, Ltd. | 2012-01-24 |
| RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3 (K110534) | Randox Laboratories Limited | 2012-01-23 |
| CONCENPIECE,HIGH-SPEED HANDPIECE SERIES (K113301) | Dentalez, Inc. | 2012-01-23 |
| AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE.. (K112161) | Radiometer Medical Aps | 2012-01-20 |
| TORQTECH (K103697) | J. Morita USA, Inc. | 2012-01-20 |
| POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (K112612) | Top Calibre Sdn Bhd | 2012-01-18 |
| CRY-ACTRACKERCAM (K110305) | Brymill Cryogenic Cystems | 2012-01-13 |
| ABSOLUTE WHITE LIGHT (K110888) | Dr. Fresh, Inc. | 2012-01-12 |
| I-ENDO DUAL (K111623) | Satelec - Acteon Group | 2012-01-10 |
| NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM (K112955) | Nova Biomedical Corporation | 2012-01-05 |
| TRIMOTION INJECTOR (K102999) | Kaneka Corp. | 2011-12-29 |
| GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT (K112352) | Bionostics, Inc. | 2011-12-23 |
| XPRESS MULTI-SINUS DILATION TOOL (K112506) | Entellus Medical, Inc. | 2011-12-21 |
| I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE (K112430) | Abbott Pont of Care, Inc. | 2011-12-20 |
| EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400 (K112869) | Beyes Dental Canada, Inc. | 2011-12-16 |
| IMMUNOCARD C. DIFFICILE GDH (K112048) | Meridian Bioscience, Inc. | 2011-12-16 |
| AIRLIGHT DENTAL HANDPIECE (K112623) | Beyes Dental Canada, Inc. | 2011-12-16 |
| PATIENT EXAMINATION GLOVE (K113193) | Suqian Ruijang Medical Supplies Co., Ltd. | 2011-12-16 |
| SAME/VARIOUS DISTRIBUTORS/WE MAY PRIVATE LABEL (K112743) | Clean Medical Manfacturing Co;Ltd | 2011-12-16 |
| BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER (K112562) | Kimberly-Clark | 2011-12-15 |
| HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE (K111753) | Hitachi Chemical Diagnostics, Inc. | 2011-12-14 |
| AIR-N-GO (K110379) | Satelec | 2011-12-08 |
| NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREE (K110698) | Terang Nusa Sdn Bhd | 2011-12-07 |
| ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT (K112125) | Meridian Bioscience, Inc. | 2011-12-05 |
| SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS) (K112610) | Inpro Technology Device Factory | 2011-12-05 |
| MAGNESIUM ASSAY (K111915) | Sekisui Diagnostics P.E.I., Inc. | 2011-12-02 |
| DYNAMIC DU SERIES PORTABLE DENTAL UNIT (K111907) | Shanghai Dynamic Industry Co., Ltd. | 2011-12-02 |
| RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL (K112337) | Randox Laboratories, Ltd. | 2011-12-01 |
| NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE) (K111248) | Yty Industry (Manjung) Sdn Bhd | 2011-12-01 |
| ROM PLUS (K110605) | Clinical Innovations, LLC | 2011-11-23 |
| DIMENSION CLINICAL CHEMISTRY SYSTEM (K112999) | Siemens Healthcare Diagnostics | 2011-11-22 |
| PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM (K110614) | Seju Engineering Co., Ltd. | 2011-11-21 |
| POWER FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR (K113191) | Suqian Ruijang Medical Supplies Co., Ltd. | 2011-11-17 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K113195) | Suqian Ruijang Medical Supplies Co., Ltd. | 2011-11-16 |
| HYPERELASTIC WIRE (K112640) | Ormco Corp. | 2011-11-16 |
| CS 1200 (K112321) | Carestream Health, Inc. | 2011-11-10 |
| ASIMANAGER - AT (K111356) | Arlington Scientific, Inc. | 2011-11-09 |
| POWDER FREE LATEX PATIENT EXAM GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS PER DM SQUARED OR LESS OF WATER SOLUBLE (K112988) | Northstar Healthcare Holdings Limited | 2011-11-09 |
| IT/IF CONTROL (K101863) | Sebia | 2011-11-07 |
| INTERDRY SILVER (K110715) | Milliken Healthcare Products, LLC | 2011-11-04 |
| ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS (K112603) | Beckman Coulter, Inc. | 2011-11-04 |