| G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE (K121335) | Hutchinson Sante S.N.C. | 2012-09-13 |
| NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES (K112693) | Sgmp Co., Ltd. | 2012-09-12 |
| TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED) (K120009) | Abbott Laboratories | 2012-09-11 |
| POWDER FREE BLACK NITRILE EXAMINATION GLOVES (K113393) | Tg Medical Sdn. Bhd. | 2012-09-11 |
| POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR (K121528) | Shen Wei (Usa), Inc. | 2012-09-11 |
| ESENSOR RESPIRATORY VIRAL PANEL (K113731) | Clinical Micro Sensors, Inc. | 2012-09-10 |
| ETS BLUE POWDER-FREE PATIENT NITRILE EXAMINATION GLOVES (K121947) | Northstar Healthcare Holdings | 2012-09-10 |
| NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (K122363) | Siam Sempermed Corp., Ltd. | 2012-09-10 |
| VITROS CHEMISTRY PRODUCTS DHDL SLIDES (K120609) | Ortho-Clinical Diagnostics, Inc. | 2012-09-07 |
| THERMO SCIENTIFIC MAS OMNI-CARDIO (K122291) | Microgenics Corporation | 2012-08-31 |
| VANTERA CLINICAL ANALYZER (K113830) | Liposcience | 2012-08-30 |
| SINUS DILATION SYSTEM (K121351) | Entrigue Surgical, Inc. | 2012-08-29 |
| ACE MAGNESIUM REGENT (K122302) | Alfa Wassermann Diagnostics Technologies, LLC | 2012-08-27 |
| ELEVANCE (K120239) | Midmark | 2012-08-24 |
| ELECSYS HSV-2 IGG IMMUNOASSAY (K121895) | Roche Diagnostics | 2012-08-24 |
| XPRESS MULTI-SINUS DILATION TOOL (K121943) | Entellus Medical, Inc. | 2012-08-22 |
| POWDER-FREE NITRIE EXAMINATION GLOVES, ORANGE (K120890) | Shen Wei (Usa), Inc. | 2012-08-17 |
| LUBE JELLY SURINGE (K121390) | Nurse Assist, Inc. | 2012-08-10 |
| NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE) (K121368) | Matang Mfg. Sdn. Bhd. | 2012-08-10 |
| POWDER FREE LATEX EXAMINATION GLOVES (K113685) | Khai Hoan Joint Stock Company | 2012-08-10 |
| IDS-ISYS IGF-I CALIBRATION VERIFIERS (K122141) | Immunodiagnostic Systems , Ltd. | 2012-08-07 |
| BD BACTEC Plus PRIME Aerobic/F Culture Vials (K120994) | Becton, Dickinson and Company | 2012-08-07 |
| NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN (K121698) | Dentsply International, Inc. | 2012-08-06 |
| NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK) (K121192) | Tekmedic (M) Sdn Bhd | 2012-08-03 |
| POWER-FREE NITRILE PATIENT EXAMINATION GLOVES (K121526) | Shandong Junchi Medical Products Co., Ltd. | 2012-08-03 |
| POWDER-FREE VIVYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K121157) | Shijazhuang Jiuyuan Plastic Co., Ltd. | 2012-08-02 |
| EON CHOLESTEROL REAGENT (K120202) | Vital Diagnostics Pty., Ltd. | 2012-07-27 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K120797) | Shandong Shouguang Kingliyuan Medical Apparatus & | 2012-07-27 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, NON-STERILE (K120230) | Shandong Taixiang Medical Products Co., Ltd. | 2012-07-27 |
| PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES (K121897) | Cardinal Health, Inc. | 2012-07-27 |
| COMPOTHIXO (K111465) | Kerrhawe SA | 2012-07-25 |
| CONE-TROL LIQUID CHEMISTRY CONTROLS (K121759) | Cone Bioproducts | 2012-07-24 |
| NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, COLORED (BLUE) (K120970) | Tangshan Zhonghong Pulin Plastic Co.,Ltd | 2012-07-19 |
| ACE ALT REAGENT (K113382) | Alfa Wassermann | 2012-07-19 |
| BLACK NITRILE POWDER-FREE EXAMINATION GLOVES (K121529) | Northstar Healthcare Holdings | 2012-07-12 |
| LIQUICHEK URINE CHEMISTRY CONTROL (K121794) | Bio-Rad, Diagnostics Grp. | 2012-07-11 |
| RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID) (K121746) | Randox Laboratories, Ltd. | 2012-07-11 |
| POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES (K120584) | Wealth on (Jiangsu) Co., Ltd. | 2012-07-10 |
| BLUE POWER FREE NITRILE EXAMINATION GLOVE (K121464) | Northstar Healthcare Holdings | 2012-07-05 |
| DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL (K121122) | Biochemical Diagnostic, Inc. | 2012-07-03 |
| UTB BLUE POWDER FREE NITRILE (K121506) | Northstar Healthcare Holdings | 2012-07-03 |
| ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT (K113262) | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-07-03 |
| TEK USA E-GENERATOR INTEGRATED LED HANDPIECE (HIGH & LOW SPEED AIR TURBNINE DENTAL HANDPIECE) (K120218) | Palm Beach Dental Supply D/B/A Tek USA | 2012-06-29 |
| POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES (K120963) | Medtexx Manufacturing Sdn. Bhd. | 2012-06-29 |
| PIXEL APP (K121274) | Gauss Surgical, Inc., | 2012-06-27 |
| NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U (K120336) | Hartalega Sdn Bhd | 2012-06-25 |
| EUROTROL GAS-ISE METABOLITES (K121468) | Eurotrol B.V. | 2012-06-22 |
| BEAM BRUSH/BEAM APP (K121165) | Beam Technologies, LLC | 2012-06-21 |
| AIRTRAQ SP AIRTRAQ AVANT (K121378) | Prodol Meditec , Ltd. | 2012-06-21 |
| RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3 (K121588) | Randox Laboratories, Ltd. | 2012-06-20 |
| ABLE-X (K120783) | Im-Able, Ltd. | 2012-06-20 |
| CONE-TROL HEMOGLOBIN A1C CONTROL SET (K121534) | Cone Bioproducts | 2012-06-20 |
| TI-MAX X450 (K112024) | Nakanishi, Inc. | 2012-06-20 |
| AUDIT MICROLQ SPINAL FLUID CONTROL (K112742) | Aalto Scientific, Ltd. | 2012-06-15 |
| DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT (K120695) | Dentist IN A Box Pty., Ltd. | 2012-06-12 |
| INVENT SNORING DEVICE (K120665) | Ventus Medical, Inc. | 2012-06-12 |
| LANO-E (K111604) | Ug Global Resources Sdn. Bhd. | 2012-06-08 |
| TRANSPORT CULTURE MEDIUM DEVICE (K120846) | Puritan Medical Products, LLC | 2012-06-08 |
| LANO-E (K111718) | Ug Global Resources Sdn. Bhd. | 2012-06-08 |
| ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT (K113438) | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-06-01 |
| NCI SPATULA (K110734) | Fischer Surgical, Inc. | 2012-05-31 |
| COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM (K121039) | Copan Flock Technologies | 2012-05-25 |
| PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 UG/DM OR LESS (K120934) | Cardinal Health, Inc. | 2012-05-23 |
| HIGH FIVE (K113440) | Central Medicare Sdn Bhd | 2012-05-23 |
| LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) (K121143) | Bio-Rad Laboratories | 2012-05-18 |
| BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE (K121237) | Cliniqa Corporation | 2012-05-18 |
| ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT (K113253) | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-05-17 |
| LIQUID BANDAGE (K120059) | Chesson Laboratory Associates, Inc. | 2012-05-17 |
| XPRESS MULTI-SINUS DILATION TOOL (K121174) | Entellus Medical, Inc. | 2012-05-17 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR (K113194) | Suqian Ruijang Medical Supplies Co., Ltd. | 2012-05-14 |
| LATEX EXAMINATION GLOVES (POWDER FREE) (K120692) | Top Calibre Sdn Bhd | 2012-05-14 |
| COMED K-SERIES MANUAL WHEELCHAIR (K120077) | Danyang Comed Healthcare Co., Ltd. | 2012-05-14 |
| DISPOSABLE POWER FREE VINYL EXAM GLOVE, PINK COLOR (K120798) | Canopus Medical Supply Co., Ltd. | 2012-05-14 |
| ELECSYS LH CALCHECK 5 (K121279) | Roche Diagnostics | 2012-05-10 |
| COMPLETE D 25-OH VITAMIN D CONTROL (K113177) | Quantimetrix Corp. | 2012-05-10 |
| LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L (K121084) | Siemens Healthcare Diagnostics, Inc. | 2012-05-09 |
| LATEX EXAMINATION GLOVES (POWDERED) (K120693) | Top Calibre Sdn Bhd | 2012-05-08 |
| C2 MEDICAL GLOVES (K113639) | Amercare, Inc. | 2012-05-08 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR (K112266) | Shandong Zhiyuan Medical Products Co., Ltd. | 2012-05-08 |
| GEN_2 MECHANICAL WHEELCHAIR (K113713) | Free Wheelchair Mission | 2012-05-07 |
| DUKAL LUBRICATING JELLY (K113689) | Dukal Corporation | 2012-05-04 |
| TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE (K112665) | J. Morita USA, Inc. | 2012-05-04 |
| RAPIDPOINT 500 BLOOD GAS ANALYER (K113216) | Siemens Healthcare Diagnostics | 2012-05-03 |
| RS SAFE BLACK NITRILE MEDICAL EXAMINATION GLOVES POWDER OR OTHER PROPRIETARY NAME (K112924) | Riverstone Resources Sdn Bhd | 2012-05-02 |
| POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLORED, BLACK COLORED AND WHITE COLORED (K120184) | Encompass Medical Supplies Inc Limited | 2012-05-02 |
| POSEY BED (K113355) | J. T. Posey Co. | 2012-05-02 |
| ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM (K121044) | Meridian Bioscience, Inc. | 2012-05-01 |
| PORTRAIT ANALYZER (DEN120013) | Great Basin Scientific | 2012-04-30 |
| STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING (K113707) | Cardinal Health-Medical Products and Services | 2012-04-27 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K113837) | Hebei Changsheng Plastic Products Co., Ltd. | 2012-04-27 |
| PATHASSIST LIGHT FIBER (K120962) | Entellus Medical, Inc. | 2012-04-27 |
| DISPOSABLE POWDER FREE VINYL EXAM GLOVES (K120746) | Canopus Medical Supply Co., Ltd. | 2012-04-27 |
| NASAL/EPISTAXIS PACK (K113585) | Cogent Therapeutics, LLC | 2012-04-25 |
| PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM (K120664) | Abaxis, Inc. | 2012-04-24 |
| PICCOLO HDL-CAPILLARY TEST SYSTEM (K120662) | Abaxis, Inc. | 2012-04-24 |
| BLUWHITE DIAMOND DENTAL BURS MODIFIED (K120037) | Beavers Dental, Div. Sybron Canada, Ltd. | 2012-04-20 |
| PALM-PRO POWDER FREE NITRILE EXAMINATION GLOVES (K111464) | Dipped Products (Thailand), Ltd. | 2012-04-19 |
| ZHENJIANG ASURE MECHANICAL WHEELCHAIR (K112816) | Zhenjiang Assure Medical Equipment Co., Ltd. | 2012-04-18 |
| VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECES (K112305) | Thunder Tiger Corp. | 2012-04-17 |
| RS SAFE WHITE NITRILE MEDICAL EXAMINATION GLOVES POWDER FREE OR OTHER PROPRIETARY NAME (K112928) | Riverstone Resources Sdn Bhd | 2012-04-17 |