| POWDER FREE NITRILE EXAMINATION GLOVE, GREEN TEA SCENTED, GREEN (K091151) | Gx Corporation Sdn Bhd | 2009-06-01 |
| NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLOR, POLYMER COATED, TESTED WITH CHEMOTHERAPY DRUGS (K082957) | Siam Sempermed Corp., Ltd. | 2009-05-29 |
| IMMUNOCARD STAT CAMPY, MODEL 751530 (K090700) | Meridian Bioscience, Inc. | 2009-05-28 |
| ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089 (K090943) | American Biological Technologies, Inc. | 2009-05-27 |
| MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES (K090676) | Anthogyr | 2009-05-22 |
| ORALUBE (K090457) | Pulpdent Corporation | 2009-05-21 |
| APLION TOPICAL CARE SYSTEM (K091133) | Aplion Medical,Llc | 2009-05-20 |
| STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE) (K090520) | Shandong Huayue Glove Co., Ltd. | 2009-05-18 |
| POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVE (K090066) | Wear Safe (Malaysia) Sdn. Bhd. | 2009-05-15 |
| TEARLAB OSMOLARITY SYSTEM (K083184) | Ocusense, Inc. | 2009-05-14 |
| VINYL EXAMINATION GLOVE, POWDER FREE CLEAR (NON-COLORED) (K090513) | Shandong Huayue Glove Co., Ltd. | 2009-05-08 |
| NON STERILE POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (K083156) | Giga-Drive Sdn, Bhd | 2009-05-08 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K090691) | Shijiazhuang Benestar Plastic Co., Ltd. | 2009-05-07 |
| ELECSYS RUBELLA IGG CALCHECK (K090311) | Roche Diagnostics | 2009-05-05 |
| GBS PNA FISH (K082612) | Advandx, Inc. | 2009-05-05 |
| VIVID, MODELS 40-A0001, 40-A0004, 40-A0006 (K090079) | Progeny, Inc. | 2009-05-01 |
| SYNTHETIC POWDER-FREE EXAM VINYL GLOVES, YELLOW/WHITE (K083931) | Quantum Co., Ltd. | 2009-04-27 |
| MOBILECARE MONITOR, MODEL 2100 (K090138) | Aframe Digital, Inc. | 2009-04-24 |
| BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (K090464) | Pt Mahakarya Inti Buana | 2009-04-23 |
| APEXUM ABLATOR (K082325) | Apexum , Ltd. | 2009-04-21 |
| CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3 (K083554) | Cliniqa Corporation | 2009-04-21 |
| PROGASTRO CD ASSAY (K090239) | Prodesse, Inc. | 2009-04-16 |
| ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090 (K090854) | American Biological Technologies, Inc. | 2009-04-16 |
| AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT (K081922) | Wallac OY | 2009-04-16 |
| VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402 (K090475) | Maine Standards Co. | 2009-04-16 |
| ORTHO T. CRUZI ELISA TEST SYSTEM (K072732) | Ortho-Clinical Diagnostics, Inc. | 2009-04-15 |
| PORTABLE OXYGEN UNIT SCA900 (K080243) | San Cheong Co. , Ltd. | 2009-04-07 |
| POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE (K090327) | Wear Safe (Malaysia) Sdn. Bhd. | 2009-04-03 |
| ALCO TUBE PLUS (K082080) | Alcotest Quebec | 2009-04-01 |
| C. DIFF QUIK CHEK COMPLETE (K082499) | Techlab, Inc. | 2009-03-26 |
| EK/P. AERUGINOSA PNA FISH (K081433) | Advandx, Inc. | 2009-03-26 |
| BACTRACK SELECT BREATHALYZER, MODEL S80 (K090067) | Khn Solutions, LLC | 2009-03-24 |
| HOYA IS INJECTOR SYSTEM (K081346) | Hoya Surgical Optics, Inc. | 2009-03-23 |
| VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901 (K083891) | Maine Standards Co. | 2009-03-23 |
| STERIS CMAX XLT SURGICAL TABLE (K090136) | STERIS Corporation | 2009-03-20 |
| BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70 (K083801) | Khn Solutions, LLC | 2009-03-19 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K090537) | Tangshan Jiteng Plastic Products Co., Ltd. | 2009-03-19 |
| BIOCLEAN CHEMO SHIELD (K081970) | Nitritex (M) Sdn. Bhd. | 2009-03-11 |
| LOUSEBUSTER (K083206) | Larada Sciences | 2009-03-10 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K083015) | Zibo Goldenline Plastic Product Co., Ltd. | 2009-03-10 |
| BLACK NITRILE EXAMINATION GLOVES (K083908) | Innovative Gloves Co;, Ltd. | 2009-03-06 |
| TRACH-ASSIST (K083702) | Mergenet Medical | 2009-03-05 |
| NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR, POLYMER COATED, TEXTED WITH CHEMOTHERAPY DRUGS (K083755) | Siam Sempermed Corp., Ltd. | 2009-03-05 |
| PRODRIVE LINE OF DENTAL HANDPIECES (K090369) | Prodrive Systems, Inc. | 2009-02-27 |
| GLUSEAL 90, MODEL GLU9010 (K083752) | Glustitch, Inc. | 2009-02-23 |
| PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES (K083101) | Sable Industries, Inc. | 2009-02-23 |
| VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED) (K083600) | Quantum Co., Ltd. | 2009-02-19 |
| EMS AIR-FLOW MASTER (K082791) | E.M.S Electro Medical Systems S.A | 2009-02-18 |
| NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM (K083252) | Dentalez Group, Stardental Division | 2009-02-18 |
| PATIENT VINYL EXAMINATION GLOVES, POWDERFREE, NON-STERILE (K083259) | Tangshan Zhongying Plastic Products Co., Ltd. | 2009-02-17 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K090016) | Suqian Clean Glove Co., Ltd. | 2009-02-13 |
| STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 (K081264) | Children'S Health First, Inc. | 2009-02-13 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K083047) | Zibo Wanci Plastic & Rubber Co., Ltd. | 2009-02-12 |
| ELECSYS TOXO IGG CALCHECK (K083655) | Roche Diagnostics | 2009-02-12 |
| N-DEX BWC PINK NITRILE MEDICAL EXAMINATION GLOVE, NON STERILE (K082428) | Best Glove, Inc. | 2009-02-10 |
| POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES (K083624) | Comfort Rubber Gloves Ind. Sdn. Bhd. | 2009-02-10 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K082690) | Hebei Handform Plastic Products Co., Ltd. | 2009-02-09 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K082691) | Hebei Handform Plastic Products Co., Ltd. | 2009-02-04 |
| PREMIER CAMPY, MODEL 618096 (K083464) | Meridian Bioscience, Inc. | 2009-01-30 |
| POWDER FREE NITRILE EXAMINATION GLOVES, BUBBLE GUM SCENTED, PINK (K083717) | Gx Corporation Sdn Bhd | 2009-01-30 |
| MARVEL PEDIATRIC WHEELCHAIR (K083847) | Rogue Wheelchairs, Inc. | 2009-01-30 |
| RELIEVA STRATUS MICROFLOW SPACER (K083574) | Acclarent, Inc. | 2009-01-29 |
| NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES (K083337) | Terang Nusa Sdn Bhd | 2009-01-27 |
| BEAU RX SCAR CARE GEL (K083718) | Beau RX Solutions, LLC | 2009-01-26 |
| PANTHERA MECHANICAL WHEELCHAIR, MODELS S2, U2, BAMBINO, MICRO, BT (K083231) | Panthera Production AB | 2009-01-26 |
| CARE3 PLUS (K081811) | Nakanishi, Inc. | 2009-01-21 |
| EPIVISION SL SYSTEM (K072102) | Gebauer Medizintechnik GmbH | 2009-01-16 |
| CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 (K081908) | Cliniqa Corporation | 2009-01-16 |
| REAL-TIME PCR INTERNAL CONTROL 2B SET (K083430) | Nanogen, Inc. | 2009-01-15 |
| A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43 (K082716) | A-Dec, Inc. | 2009-01-15 |
| NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE (K081911) | Siam Sempermed Corp., Ltd. | 2009-01-15 |
| INTRATEMP SOLUTION WARMER (K083417) | C Change Surgical, LLC | 2009-01-13 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K082936) | Zibo Litong Plastic Products Co., Ltd. | 2009-01-12 |
| AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1 (K081767) | Amnisure International, LLC | 2009-01-09 |
| PAIN VISION, MODEL PS-2100 (K072882) | Osachi Co., Ltd. | 2009-01-08 |
| MODIFICATION TO ZENIEVA (K083721) | River'S Edge Pharmaceuticals, LLC | 2009-01-08 |
| POWDER FREE BLUE PATIENT NITRILE EXAMINATION GLOVE (K082598) | Tangshan Zhonghong Pulin Group Co., Ltd. | 2009-01-07 |
| A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT (K082827) | A-Dec, Inc. | 2009-01-07 |
| VIROCULT, MODEL MW950 (K082472) | Medical Wire & Equipment Company (Bath), Ltd. | 2008-12-30 |
| BD BACTEC Plus Aerobic/F Culture Vials (K083572) | Becton, Dickinson & CO | 2008-12-24 |
| D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT (K081928) | Diagnostic Hybrids, Inc. | 2008-12-23 |
| BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES (K081971) | Nitritex (M) Sdn. Bhd. | 2008-12-23 |
| D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT (K081746) | Diagnostic Hybrids, Inc. | 2008-12-23 |
| ABT GLUCOSE CONTROL SOLUTION (K083549) | American Biological Technologies, Inc. | 2008-12-22 |
| IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS) (K081855) | Canada, Inc. | 2008-12-19 |
| KEY RING ALCOHOL BREATHALYZER (K082086) | The Ashley Collection, Inc. | 2008-12-19 |
| BD GENEOHM CDIFF ASSAY (K081920) | Bd Diagnostics (Geneohm Sciences, Inc.) | 2008-12-19 |
| E.COLI/P. AERUGINOSA PNA FISH (K081309) | Advandx, Inc. | 2008-12-19 |
| GRAFTGUARD PRESSURE CONTROLLING SYRINGE (K082725) | Maquet Cardiovascular, LLC | 2008-12-17 |
| A-DEC 334/335 DELIVERY SYSTEM (K082985) | A-Dec, Inc. | 2008-12-17 |
| MARVEL WHEELCHAIR, MODEL EDCAL01 (K082970) | Rogue Wheels, Inc. | 2008-12-12 |
| HUBANG, MODEL HBL13/HBG12-S (K083044) | Shanghai Hubang Medical Appliances Co., Ltd. | 2008-12-12 |
| BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES (K081972) | Nitritex (M) Sdn. Bhd. | 2008-12-11 |
| BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY (K081824) | Becton, Dickinson & CO | 2008-12-11 |
| DISPOSABLE VINYL SYNTHETIC EXAMINATION GLOVES, POWDERED (K082448) | Rich Mountain Medical Products, Inc. | 2008-12-10 |
| POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM (K082302) | Pt. Medisafe Technologies | 2008-12-09 |
| POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES (K081592) | Quality Gallant Sdn. Bhd. | 2008-12-03 |
| DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER (K082208) | Scivolutions, Inc. | 2008-12-01 |
| N-DEX FREE NIGHTHAWK BLACK NITRILE MEDICAL EXAMINATION GLOVE, POWDER -FREE, MODEL# 7700PFT (K082125) | Best Glove, Inc. | 2008-11-21 |
| VERTEBRAL ACCESS SYSTEM BY VIDACARE (K081713) | Vidacare Corporation | 2008-11-21 |