| MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C (K124009) | Diamond Diagnostics, Inc. | 2013-04-17 |
| Z CARTRIDGE IOL DELIVERY SYSTEM (K123888) | Aaren Scientific, Inc. | 2013-04-15 |
| LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK (K130761) | Bio-Rad Laboratories | 2013-04-12 |
| MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, ORANGE (K122464) | Industrial Clothings, Ltd. | 2013-04-12 |
| MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, GREY (K122453) | Industrial Clothings, Ltd. | 2013-04-05 |
| POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT (K122494) | Hemostasis, LLC | 2013-03-27 |
| HIGH METABOLITE QUALICHECK (K130415) | Radiometer Medical Aps | 2013-03-26 |
| DIMENSION EXL WITH LM SYSTEM (K130276) | Siemens Healthcare Diagnostics, Inc. | 2013-03-22 |
| AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET (K130157) | Aalto Scientific, Ltd. | 2013-03-19 |
| STERILE LATEX SURGICAL GLOVE (K123628) | Lucenxia Prescience AG | 2013-03-18 |
| RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3 (K130236) | Radiometer Medical Aps | 2013-03-15 |
| IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL (K122534) | Siemens Healthcare Diagnostics, Inc. | 2013-03-14 |
| PICCOLO LACTATE TEST SYSTEM (K130113) | Abaxis, Inc. | 2013-03-11 |
| DISCOVERY TMAX MANUAL WHEELCHAIR (K113164) | Otto Bock Healthcare LP | 2013-03-11 |
| FASTPACK CONTROL KIT (K123725) | Qualigen, Inc. | 2013-03-08 |
| DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL) (K123677) | Siemens Healthcare Diagnostics | 2013-03-07 |
| MULTIPLE NAME (K123819) | Top Calibre Sdn Bhd | 2013-03-05 |
| LIQUID ASSAYED MULTIQUAL PREMIUM (K130162) | Bio-Rad Laboratories | 2013-03-01 |
| POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE (K123749) | Kossan Latex Industries(M)Sdn Bhd | 2013-03-01 |
| POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES (K123869) | Dehai (Shandong) Medical Gloves, Co., Ltd. | 2013-02-28 |
| TI-MAX Z45 (K121901) | Nakanishi, Inc. | 2013-02-28 |
| MYVISIONTRACK(TM) (K121738) | Vital Art and Science Incorporated | 2013-02-22 |
| T:CONNECT DATA MANAGEMENT SYSTEM (K122361) | Tandem Diabetes Care, Inc. | 2013-02-22 |
| BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE (K122727) | Northstar Healthcare Holdings | 2013-02-22 |
| POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE (K130038) | Hl Rubber Industries Sdn Bhd | 2013-02-21 |
| POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILE (K123469) | Wear Safe (Malaysia) Sdn Bhd - Facility II | 2013-02-19 |
| PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM (K130200) | Abaxis, Inc. | 2013-02-15 |
| DIMENSION AMMONIA FLEX REAGENT CARTRIDGE (K123320) | Siemens Healthcare Diagnostics | 2013-02-15 |
| GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK (K123851) | Bionostics, Inc. | 2013-02-14 |
| CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR) (K123116) | Worldmed Manufacturing Sdn. Bhd. | 2013-02-11 |
| LINSHI NITRILE DISPOSABLE EXAM GLOVES, POWDER-FREE (K123488) | Puyang Linshi Health Co., Ltd. | 2013-02-08 |
| BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP (K122718) | Becton, Dickinson and Company | 2013-02-06 |
| POWDER FREE LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM, NATURAL COLOR (K123757) | Assurguard Sdn. Bhd. | 2013-02-01 |
| AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL (K121456) | Arkray, Inc. | 2013-02-01 |
| POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE) (K122696) | Cardinal Health, Inc. | 2013-01-31 |
| POWERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K122396) | Wealth on (Jiangsu) Co., Ltd. | 2013-01-31 |
| LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK (K123775) | Bio-Rad Laboratories | 2013-01-31 |
| MULTIPLE NAME (K123760) | Assurguard Sdn. Bhd. | 2013-01-28 |
| BACT/ALERT FN PLUS CULTURE BOTTLE (K121455) | bioMerieux, Inc. | 2013-01-25 |
| DECLIPSESPECT VIEWER (K123917) | Surgiceye GmbH | 2013-01-25 |
| LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET (K122793) | DiaSorin, Inc. | 2013-01-25 |
| GLUCOSE METER-CHECK SOLUTION FOR BAYER (K123966) | Bionostics, Inc. | 2013-01-25 |
| LANTOS 3D EAR SCANNER (K121326) | Lantos Technologies | 2013-01-25 |
| BACT/ALERT PF PLUS CULTURE BOTTLE (K121446) | bioMerieux, Inc. | 2013-01-25 |
| BACT/ALERT FA PLUS CULTURE BOTTLE (K121461) | bioMerieux, Inc. | 2013-01-22 |
| POWDER FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK (K123328) | Nitrilist Gloves Manufacturing Sdn Bhd | 2013-01-18 |
| POWDER FREE BLUE NITRILE EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS (K121592) | Tekmedic (M) Sdn Bhd | 2013-01-18 |
| POWDER FREE NITRILE EXAMINATION GLOVES (BLACK, WHITE, GREEN) (K122408) | Hongye Plastic Products Co., Ltd. | 2013-01-17 |
| FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA (K123612) | Fujirebio Diagnostics,Inc. | 2013-01-17 |
| TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 UG/DM2 O (K122788) | Northstar Healthcare Holdings | 2013-01-17 |
| ERGO IMAGING SYSTEM (K123408) | Digirad Corp. | 2013-01-15 |
| LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK (K123798) | Bio-Rad Laboratories | 2013-01-09 |
| ENTEROCOCCUS QUICKFISH BC (K121991) | Advandx, Inc. | 2013-01-07 |
| NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE (K121549) | Siam Sempermed Corp., Ltd. | 2012-12-27 |
| EZ-ASSIST-FILL (K121661) | Assist Fill, LLC | 2012-12-27 |
| LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK (K123663) | Bio-Rad Laboratories | 2012-12-27 |
| MR4500 WHEELCHAIR (K120391) | Wardray Premise, Ltd. | 2012-12-21 |
| FINN CHAMBERS AQUA (K123184) | Smartpractice | 2012-12-19 |
| HELIO (K120628) | Motion Composites | 2012-12-19 |
| TRAUS SIP10 (K123695) | Saeshin Precision Co., Ltd. | 2012-12-18 |
| POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE (K122874) | Nitrilist Gloves Manufacturing Sdn Bhd | 2012-12-10 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) (K122828) | Shandong Hongxin Chemicals Co., Ltd. | 2012-12-10 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) (K122835) | Yuanhang Plastic Co., Ltd. | 2012-12-10 |
| ELECSYS CA 15-3 II CALCHECK 5 (K122242) | Roche Diagnostics | 2012-12-05 |
| POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K122999) | Top Glove Sdn. Bhd. | 2012-11-30 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) (K122893) | Geenli Plastic Co, Ltd. | 2012-11-30 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) (K122920) | Hebei Leader Plastic Co., Ltd. | 2012-11-30 |
| TANDA PEARL, ULTRAWYTE, PEARL (K122725) | Syneron Beauty | 2012-11-27 |
| POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES (K121811) | Shen Wei (Usa), Inc. | 2012-11-21 |
| RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3 (K121603) | Randox Laboratories, Ltd. | 2012-11-20 |
| LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA (K123198) | Bio-Rad Laboratories | 2012-11-20 |
| PEDIATRIC POSITIONER PAD SET (K122174) | Ge Healthcare Coils (Usa Instruments, Inc.) | 2012-11-16 |
| POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL (K120066) | Kossan Latex Industries(M)Sdn Bhd | 2012-11-16 |
| TEXTURED, BLUE, LATEX, POWDER FREE EXAMINATION GLVOES, WITH PROTEIN LABELING CLAIM (50UG/DM OR LESS OF WATER SOLUBLE PRO (K123026) | Northstar Healthcare Holdings | 2012-11-16 |
| BLUE POWDERED NITRILE EXAMINATION GLOVE (K122998) | Northstar Healthcare Holdings | 2012-11-06 |
| INSURGICAL SINGLE USE POWER EQUIPMENT (K112599) | Insurgical, LLC | 2012-11-06 |
| RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM (K120280) | Acclarent, Inc. | 2012-11-05 |
| OSOM INFLUENZA A&B TEST MODEL 190 (K123182) | SEKISUI Diagnostics, LLC | 2012-11-05 |
| XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX) (K121539) | Cepheid | 2012-11-02 |
| BIOPLEX 2200 EBV IGM KIT (K123021) | Bio-Rad Laboratories | 2012-11-02 |
| COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE) (K121594) | Tekmedic (M) Sdn Bhd | 2012-10-25 |
| POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY) (K122131) | Matang Mfg. Sdn. Bhd. | 2012-10-17 |
| LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK (K122838) | Bio-Rad Laboratories | 2012-10-17 |
| POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR (K121992) | Xinwei (Shandong) Plastic and Rubber Products Co., | 2012-10-16 |
| MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, PINK (K122465) | Industrial Clothings, Ltd. | 2012-10-16 |
| FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY) (K121591) | Tekmedic (M) Sdn Bhd | 2012-10-11 |
| ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT (K122757) | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-10-05 |
| ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET (K120110) | Profit Point Manufacturing Sdn Bhd | 2012-10-04 |
| EK DELIVERY DEVICE (K121579) | Tdak Medical, Inc. | 2012-10-03 |
| SHIGA TOXIN CHEK (K121411) | Techlab Inc., Corporate Research Center | 2012-10-02 |
| SHIGA TOXIN QUIK CHEK (K121364) | Techlab Inc., Corporate Research Center | 2012-10-02 |
| BAUSCH & LOMB IOL INJECTOR (K113852) | Bausch & Lomb, Inc. | 2012-09-28 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K122266) | Shandong Junfeng Industries Co., Ltd. | 2012-09-27 |
| RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3 (K113720) | Randox Laboratories, Ltd. | 2012-09-20 |
| CHAMP CHAMP TRANSIT (K120501) | Convaid Products, Inc. | 2012-09-20 |
| BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM (K121926) | Northstar Healthcare Holdings | 2012-09-20 |
| POWER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) (K120968) | Tangshan Zhonghong Pulin Plastic Co.,Ltd | 2012-09-19 |
| BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV (K121633) | Becton, Dickinson and Company | 2012-09-18 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVE (K112741) | Lifestyle Safty Products (Hui Zhou) Co., Ltd. | 2012-09-13 |
| STREPTOCOCCUS APP. SEROLOGICAL REAGENTS (K122019) | Meridian Bioscience, Inc. | 2012-09-13 |