| POWDER FREE NATURAL RUBBER LOW MODULUS LATEX PATIENT EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (K072300) | Perusahaan Pelindung Getah (M) Sdn Bhd | 2008-05-16 |
| SMART SAVERS POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK AND GRAY) (K080165) | Platinum Glove Industries Sdn. Bhd. | 2008-05-14 |
| PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM (K080674) | PAJUNK GmbH Medizintechnologie | 2008-05-09 |
| LYRIC HEARING AID (K081136) | Insound Medical, Inc. | 2008-05-08 |
| TC MATRIX CLINICAL CHEMISTRY ANALYZER (K073370) | Teco Diagnostics | 2008-05-08 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K071999) | Tangshan Hongyun Plastic Products Co., Ltd. | 2008-05-08 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K072084) | Zibo Hongye Shangqin Plastic Rubbert Co, Ltd. | 2008-05-08 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES (K073192) | Shijiazhuang Prosperous Plastic Co., Ltd. | 2008-05-02 |
| LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM (K080158) | Lb Medical LLC | 2008-05-02 |
| MAS TOX CONTROL (K080085) | Thermo Fisher Scientific | 2008-04-30 |
| NON STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, POLYMER COATING WITH CHEMOTHERAPY CLAIM (K080520) | Siam Sempermed Corp., Ltd. | 2008-04-30 |
| SURGI GLOVES (K073447) | Metacure Surgical Gloves Sdn Bhd | 2008-04-24 |
| CENTURION SORBAVIEW OTC (K080524) | Tri-State Hospital Supply Corp. | 2008-04-23 |
| YULEX LATEX POWDER-FREE EXAM GLOVES (K063810) | Yulex Corporation | 2008-04-18 |
| MANUAL RIGID MOBILITY WHEELCHAIR (K080270) | Freedom Designs, Inc. | 2008-04-16 |
| CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES (K072814) | Covidien | 2008-04-16 |
| MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVE (K072614) | Matang Mfg. Sdn. Bhd. | 2008-04-15 |
| HDL CHOLESTEROL REAGENT, MODEL 10211 (K073497) | Medica Corp. | 2008-04-14 |
| RTM AND OVAL (K080880) | Next Mobility, LLC | 2008-04-09 |
| ENTELLUS MEDICAL RS-SERIES SYSTEM (K072302) | Entellus Medical, Inc. | 2008-04-08 |
| DENTAL UNIT WITH CHAIR (K080438) | North West Medical Instrument (Group) Co., Ltd. | 2008-04-04 |
| SPIRUS MEDICAL SURGICAL INSTRUMENT (K080042) | Spirus Medical, Inc. | 2008-04-03 |
| NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES (K072400) | Sgmp Co., Ltd. | 2008-03-27 |
| NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (200 UG OR LESS) (K072403) | Sgmp Co., Ltd. | 2008-03-27 |
| CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500 (K080183) | Roche Diagnostics Corp. | 2008-03-25 |
| NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (50 UG OR LESS) (K072406) | Sgmp Co., Ltd. | 2008-03-21 |
| ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE (K073652) | Nakamura Magnifier Co., Ltd. | 2008-03-20 |
| SINUS SPACER (K072891) | Acclarent, Inc. | 2008-03-19 |
| MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM (K073591) | Staar Surgical Co. | 2008-03-13 |
| MOUNTABLE ENDOSCOPIC BLADE (K080133) | A.M. Surgical, Inc. | 2008-03-13 |
| MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM (K073586) | Staar Surgical Co. | 2008-03-13 |
| POWDER-FREE LATEX EXAMINATION GLOVES - 18 MILS AT FINGER, BLUE COLOR; 9 AND 10 MILS AT FINGER, NATURAL COLOR (K072197) | Metacure Surgical Gloves Sdn Bhd | 2008-03-12 |
| DANYANG HUAYI K2 AND K7 WHEELCHAIRS (K080207) | Danyang Huayi Medical Supply & Equipment Co, Ltd. | 2008-03-12 |
| DRAEGER ALCOTEST 6510 (K063443) | Drager Safety | 2008-03-11 |
| RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER (K073041) | Acclarent, Inc. | 2008-03-11 |
| DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX (K073488) | Diazyme Laboratories | 2008-03-07 |
| BLUE LATEX EXAM GLOVES NON STERILE CHLORINATED POWDER FREE (K073299) | Betel Care Sdn. Bhd. | 2008-03-05 |
| VFLEX POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK, AND GRAY COLOR) (K080066) | Gx Corporation Sdn Bhd | 2008-03-05 |
| SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIENT EXAMINATION GLOVE (K072802) | Ultrawin Sdn Bhd | 2008-02-29 |
| EI DOWNPAK BARRIER SLEEVES (K073369) | Hu-Friedy Mfg. Co., Inc. | 2008-02-27 |
| ELECSYS PROBNP II CALCHECK (K080147) | Roche Diagnostics Corp. | 2008-02-27 |
| QUIKCLOT NOSEBLEED (K080247) | Z-Medica Corporation | 2008-02-27 |
| MEDICAL GLOVE SERIES (K072145) | Zhanjiang Jiali Glove Products Co., Ltd. | 2008-02-26 |
| DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B (K073072) | Dade Behring, Inc. | 2008-02-21 |
| VINYL EXAMINATION GLOVE, POWDERED (K072223) | Pinnacle Co., Ltd. | 2008-02-21 |
| EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT (K072249) | Medica Corp. | 2008-02-20 |
| VINYL EXAMINATION GLOVE POWDER FREE (K072227) | Pinnacle Co., Ltd. | 2008-02-15 |
| HUAYI H035 BASIC WHEELCHAIR (K080114) | Danyang Huayi Medical Supply & Equipment Co, Ltd. | 2008-02-15 |
| SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE) (K072228) | Pinnacle Co., Ltd. | 2008-02-08 |
| CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE (K080240) | Promident, LLC | 2008-02-07 |
| ORAL-B SUB-BRAND MANUAL TOOTHBRUSH (K073224) | Procter & Gamble | 2008-02-06 |
| STATMATIC 31 HANDPIECE MAINTENANCE UNIT (K073319) | Scican , Ltd. | 2008-02-04 |
| MUSMATE WALKING AID (K073521) | Musmate, Ltd. | 2008-02-04 |
| PROVISA CEM (K073539) | Cavex Holland BV | 2008-01-31 |
| MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL (K072257) | More Diagnostics | 2008-01-30 |
| GELSPRAY WOUND DRESSING (K073663) | Biocure, Inc. | 2008-01-30 |
| ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE (K062534) | Drg Intl., Inc. | 2008-01-29 |
| AXIS SYSTEM (K072989) | Dentsply Intl., Inc. | 2008-01-28 |
| AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE (K072754) | Axenic Dental, Inc. | 2008-01-25 |
| G-TRAINER MEDICAL (K072887) | Alter-G, Inc. | 2008-01-25 |
| INSUCOZI INSULIN VIAL COVER (K072174) | 41 Industries, LLC | 2008-01-25 |
| QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 (K073080) | Bio-Rad Laboratories | 2008-01-24 |
| DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS (K072523) | General Atomics | 2008-01-22 |
| START JUNIOR (K073512) | Otto Bock Healthcare LP | 2008-01-14 |
| REDLINE ALCOHOL BREATH TESTER (K072953) | Redline Products (Pty) , Ltd. | 2008-01-07 |
| DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS (K072395) | Diazyme Laboratories | 2008-01-03 |
| CHOLESTRAK HDL CHOLESTEROL HOME TEST (K072836) | Accutech, LLC | 2007-12-27 |
| IRISPEC,CA/CB/CC (K072640) | Iris Diagnostics | 2007-12-21 |
| VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118 (K072138) | bioMerieux, Inc. | 2007-12-21 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K073193) | Shijiazhuang Prosperous Plastic Co., Ltd. | 2007-12-20 |
| T-QUEST SYSTEM (K073456) | Medx, Inc. | 2007-12-20 |
| BELMONT QUOLIS 5000 SERIES DENTAL UNIT (K072273) | Takara Belmont USA, Inc. | 2007-12-20 |
| ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118) (K071706) | Clinical Data, Inc. | 2007-12-20 |
| AIR-FLOW MASTER STANDARD (K073284) | (Ems Sa) Electro Medical Systems | 2007-12-14 |
| FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C (K071353) | Shanghai Foshion Medical Instruments Co., Ltd. | 2007-12-14 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVE, WHITE COLOR (K072377) | Xuzhou Full Sun Medical Products , Ltd. | 2007-12-14 |
| DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES (K071746) | Ansell Healthcare Products, LLC | 2007-12-13 |
| DISPOSABLE POWDERED VINYL EXAM GLOVE, YELLOW COLOR (K071122) | Xuzhou Full Sun Medical Products , Ltd. | 2007-12-12 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR (K072314) | Xuzhou Full Sun Medical Products , Ltd. | 2007-12-12 |
| LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK (K072835) | Bio-Rad, Diagnostics Grp. | 2007-12-11 |
| LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC (K072721) | Bio-Rad, Diagnostics Grp. | 2007-12-11 |
| DO-ALL DENTAL HANDPIECE LUBRICANT (K073353) | Prodrive Systems, Inc. | 2007-12-07 |
| TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5 (K072892) | Biosite Incorporated | 2007-12-07 |
| LEUKO EZ VUE (K071712) | Techlab Inc., Corporate Research Center | 2007-12-04 |
| BBL CHROMAGAR 0157 (K070691) | Becton, Dickinson & CO | 2007-11-20 |
| MICROLUX/BLU (K072309) | Addent, Inc. | 2007-11-19 |
| YUYUAN LATEX EXAMINATION GLOVE, POWDERED (K072639) | Shandong Yuyuan Latex Gloves Company , Ltd. | 2007-11-19 |
| SMARTSPONGE PLUS SYSTEM (K073180) | Clearcount Medical Solutions, Inc. | 2007-11-19 |
| ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES (K072554) | Sable Industries, Inc. | 2007-11-14 |
| ROYALE AE 9036 LSP INJECTOR (K073010) | Asico, LLC | 2007-11-07 |
| IOL INJECTOR SET (K070669) | Medicel AG | 2007-11-01 |
| DISPOSABLE VINYL EXAMINATION GLOVE, POWDERED (K072472) | Xuzhou Full Sun Medical Products , Ltd. | 2007-10-25 |
| QUANTRX FEMALE FERTILITY TEST (K070484) | Quantrx Biomedical Corporation | 2007-10-22 |
| LANFAN POWDER-FREE VINYL EXAM GLOVES (K072488) | Shanghai Lanfan Co., Ltd. | 2007-10-19 |
| TRU RSV (K071101) | Meridian Bioscience, Inc. | 2007-10-18 |
| DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR (K072401) | Xuzhou Full Sun Medical Products , Ltd. | 2007-10-15 |
| PTS PANELS CHOL+HDL PANEL TEST STRIPS (K071593) | Polymer Technology Systems, Inc. | 2007-10-15 |
| AMNISCREEN HOME DETECTION LINER KIT (K071100) | Common Sense , Ltd. | 2007-10-15 |
| ACON UTI URINARY TRACT INFECTION TEST STRIPS (K063295) | ACON Laboratories, Inc. | 2007-10-12 |
| HI-SPEED TURBINE HANDPIECES, MODEL GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-D (K071561) | Beijing North Pole Dental Handpiece Co., Ltd. | 2007-10-12 |