| INTRAVENOUS POWER INJECTOR EXTENSION SET (K090134) | C.R. Bard, Inc. | 2009-04-21 |
| MODIFICATION TO: GIRAFFE AND PANDA WARMER (K090697) | Ohmeda Medical | 2009-04-16 |
| ACTHERM INFRARED EAR THERMOMETER, ACT 8000 SERIES; PROBE COVER FOR ACTHERM INFRARED EAR THERMOMETER, MODEL MEDACCU2010 (K090031) | Actherm, Inc. | 2009-04-16 |
| TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER (K082997) | Terumo Medical Corp. | 2009-04-15 |
| BLOOD TRANSFUSION SET (K083349) | Shan Dong Wei Gao Group Medical Polymer Products | 2009-04-10 |
| ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE (K090189) | Icu Medical, Inc. | 2009-04-10 |
| MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM (K090087) | Iradimed Corporation | 2009-04-07 |
| SPINNING SPIROS, MODEL CH-2000 (K082806) | Icu Medical, Inc. | 2009-04-06 |
| 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 |
| ZETAJET (K090003) | Bioject, Inc. | 2009-04-02 |
| COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET (K083482) | Cook Vascular, Inc. | 2009-04-02 |
| POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETER (K090512) | C.R. Bard, Inc. | 2009-03-27 |
| KIMGUARD ONE-STEP STERILIZATION WRAP (K082177) | Kimberly-Clark Corp. | 2009-03-27 |
| PHASEAL PROTECTOR P14, P21, P28 AND P50 (K090634) | Carmel Pharma Ab. | 2009-03-23 |
| STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE (K082689) | Spectra Medical Devices, Inc. | 2009-03-20 |
| PICC (CT RATED AND NON-RATED) (K083873) | Pfm Medical, Inc. | 2009-03-19 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K090537) | Tangshan Jiteng Plastic Products Co., Ltd. | 2009-03-19 |
| SMITH & NEPHEW INSTRUMENT TRAYS (K090562) | Smith & Nephew, Inc. | 2009-03-18 |
| ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN (K083763) | R4 Vascular, Inc. | 2009-03-16 |
| SERIM DISINTEK GTA 2.1%, MODEL: 5164 (K083295) | Serim Research Corp. | 2009-03-16 |
| VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED (VH2O2) STERILIZATION PROCESSES (K090514) | STERIS Corporation | 2009-03-16 |
| SUPERCATH 5 (K081953) | Togo Medikit Co., Ltd. | 2009-03-12 |
| BIOCLEAN CHEMO SHIELD (K081970) | Nitritex (M) Sdn. Bhd. | 2009-03-11 |
| CADI SMARTSENSE VITAL SIGNS AND WIRELESS TEMPERATURE MONITORI NG SYSTEM, MODEL S1 (K083185) | Cadi Scientific Pte.Ltd | 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 |
| FORA IR20B EAR THERMOMETER, MODEL TD-1261F, FORA IR21B EAR THERMOMETER, MODEL TD-1261E (K090395) | Taidoc Technology Corporation | 2009-03-10 |
| NOVA SAFE SCALP VEIN BLOOD COLLECTION SET (K090502) | U.S. Safety Syringes Co., Inc. | 2009-03-10 |
| BLACK NITRILE EXAMINATION GLOVES (K083908) | Innovative Gloves Co;, Ltd. | 2009-03-06 |
| EMU-GRAPH 4 EMULATOR, MODEL CI 144 (K083650) | Steritec Products, Inc. | 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 |
| MODIFICATION TO SECURACATH, MODEL: SPK01 (K083081) | Interrad Medical, Inc. | 2009-03-04 |
| ENVIRO SHARP SOLUTIONS 3 (K083511) | Industrial Water Solutions, Inc. | 2009-03-03 |
| MEDILED PHOTOTHERAPY LAMP (K083179) | Medix I.C.S.A. | 2009-02-27 |
| FORA IR22 EAR THERMOMETER, MODEL TD-1262 (K090294) | Taidoc Technology Corporation | 2009-02-26 |
| PHARMAJET NEEDLE-FREE INJECTION SYSTEM (K081532) | Pharmajet, Inc. | 2009-02-26 |
| ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES (K082836) | Icu Medical, Inc. | 2009-02-25 |
| GLUSEAL 90, MODEL GLU9010 (K083752) | Glustitch, Inc. | 2009-02-23 |
| EVICEL APPLICATION DEVICE (K090162) | Omrix Biopharmaceuticals , Ltd. | 2009-02-20 |
| FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM (K083225) | Abbott Diabetes Care, Inc. | 2009-02-20 |
| VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED) (K083600) | Quantum Co., Ltd. | 2009-02-19 |
| PATIENT VINYL EXAMINATION GLOVES, POWDERFREE, NON-STERILE (K083259) | Tangshan Zhongying Plastic Products Co., Ltd. | 2009-02-17 |
| REVAC AUTO RETRACTABLE SAFETY SYRINGE (K083193) | Revolutions Medical Corporation, Inc. | 2009-02-13 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K090016) | Suqian Clean Glove Co., Ltd. | 2009-02-13 |
| FLU-ADMIN, MODELS 60150, 60150C, 60151C, 60153C, 60160 (K082027) | Genesis Bps, LLC | 2009-02-13 |
| TACTIPEN (K083457) | Haselmeier GmbH | 2009-02-13 |
| STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 (K081264) | Children'S Health First, Inc. | 2009-02-13 |
| BELMONT HYPERTHERMIA PUMP (K090089) | Belmont Instrument Corp. | 2009-02-12 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K083047) | Zibo Wanci Plastic & Rubber Co., Ltd. | 2009-02-12 |
| NEO MAPCATH SENSOR STYLET (K083121) | Corpak Medsystems | 2009-02-11 |
| 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 |
| NUOVOGUARD (K090122) | U.S. Safety Syringes Co., Inc. | 2009-02-05 |
| IRRISEPT WOUND CLEANSING SYSTEM (K080779) | Irrimax Corporation | 2009-02-04 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K082691) | Hebei Handform Plastic Products Co., Ltd. | 2009-02-04 |
| AIDERA DIASEND (K083221) | Aidera AB | 2009-02-03 |
| EQUASHIELD SYSTEM (K083152) | Plastmed, Ltd. | 2009-02-02 |
| POWDER FREE NITRILE EXAMINATION GLOVES, BUBBLE GUM SCENTED, PINK (K083717) | Gx Corporation Sdn Bhd | 2009-01-30 |
| ALL-IN-ONE CONTAINER (K090096) | Baxter Healthcare Corporation | 2009-01-30 |
| PATIENT ISOLATION UNIT, MODEL G019-1000 (K080117) | Gentex Corporation | 2009-01-30 |
| NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES (K083337) | Terang Nusa Sdn Bhd | 2009-01-27 |
| AIRGENT, MODEL AG7000010 (K082138) | Perfaction, Inc. | 2009-01-23 |
| PASTURE, MODELS: F550, A520 (K083176) | Pasture Pharma Pte, Ltd. | 2009-01-23 |
| MEDIGARD BLOOD COLLECTION DEVICE (K082511) | Medigard Limited | 2009-01-16 |
| NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE (K081911) | Siam Sempermed Corp., Ltd. | 2009-01-15 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K082936) | Zibo Litong Plastic Products Co., Ltd. | 2009-01-12 |
| POWDER FREE BLUE PATIENT NITRILE EXAMINATION GLOVE (K082598) | Tangshan Zhonghong Pulin Group Co., Ltd. | 2009-01-07 |
| VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK (K073618) | STERIS Corporation | 2009-01-07 |
| AMSCO EVOLUTION MEDIUM STEAM STERILIZER (K082435) | STERIS Corporation | 2008-12-30 |
| MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL (K083765) | Medegen Medical Manufacturing Services | 2008-12-30 |
| BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES (K081971) | Nitritex (M) Sdn. Bhd. | 2008-12-23 |
| MISER CONTRAST MANAGEMENT SYSTEM (K083576) | Merit Medical Systems, Inc. | 2008-12-23 |
| SUBCUTANEOUS NEEDLE INFUSION SET (K082818) | Marcal Medical, Inc. | 2008-12-23 |
| ASTOFLO PLUS (K082765) | Stihler Electronic GmbH | 2008-12-18 |
| STERILE FIELD SALINE PRE-FILLED SYRINGE(S) (K082837) | Excelsior Medical Corp. | 2008-12-18 |
| PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE (K081412) | Hospira, Inc. | 2008-12-17 |
| SYMPHONY METER REMOTE (K082590) | Lifescan, Inc. | 2008-12-17 |
| CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE (K082783) | Smiths Medical MD, Inc. | 2008-12-17 |
| FLOWPICC CATHETER (K082481) | Vasonova, Inc. | 2008-12-17 |
| INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200 (K081788) | Innochips Technology Co., Ltd. | 2008-12-17 |
| SHARPS COMPLIANCE CONTAINER (K083129) | Sharps Compliance, Inc. | 2008-12-15 |
| BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES (K081972) | Nitritex (M) Sdn. Bhd. | 2008-12-11 |
| DISPOSABLE VINYL SYNTHETIC EXAMINATION GLOVES, POWDERED (K082448) | Rich Mountain Medical Products, Inc. | 2008-12-10 |
| TAIDOC TD-11 SERIES AND CLEVER TD-1112 EAR/SKIN/ SURFACE IR THERMOMETERS & FORA IR16/17 EAR THERMOMETER (K083299) | Taidoc Technology Corporation | 2008-12-10 |
| MEDEGEN PRESSURE RATED EXTENSION SETS (K083472) | Medegen, Inc. | 2008-12-09 |
| POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM (K082302) | Pt. Medisafe Technologies | 2008-12-09 |
| STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS (K080558) | Case Medical, Inc. | 2008-12-05 |
| NUOVOCATH (K083454) | U.S. Safety Syringes Co., Inc. | 2008-12-04 |
| POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES (K081592) | Quality Gallant Sdn. Bhd. | 2008-12-03 |
| SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE (K082674) | Spectra Medical Devices, Inc. | 2008-11-28 |
| N-DEX FREE NIGHTHAWK BLACK NITRILE MEDICAL EXAMINATION GLOVE, POWDER -FREE, MODEL# 7700PFT (K082125) | Best Glove, Inc. | 2008-11-21 |
| STERI-LUB LUBRICATION GEL (K083189) | Avail Medical Products, Inc. | 2008-11-21 |
| NEXUS I.V. NEEDLESS ACCESS CANNULA FOR INTRAVASCULAR ADMINISTRATION SETS (K081123) | Nexus Medical, LLC | 2008-11-14 |
| RHAPSODY MRI (K082126) | Grantadler Corporation | 2008-11-13 |
| RHAPSODY CT (K081889) | Grantadler Corporation | 2008-11-12 |
| MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE) (K082457) | Ansell Healthcare Products, Inc. | 2008-11-10 |
| NEXUS I.V. FLUID TRANSFER DEVICE (K080976) | Nexus Medical, LLC | 2008-11-10 |
| DIGITAL CLINICAL THERMOMETER MODEL V9XX (K082266) | Amperor-Electronic(Sz) Co., Ltd. | 2008-11-07 |
| MICROMYST APPLICATOR, MODEL 20-5000 (K082454) | Covidien | 2008-11-07 |