| AIRSONNETT AIRSHOWER AIR 3 (K081062) | Airsonett, Inc. | 2008-11-07 |
| VANISHPOINT I.V. CATHETER (K081420) | Retractable Technologies, Inc. | 2008-11-07 |
| MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE (K082595) | Roche Diagnostics | 2008-10-28 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K082597) | Tangshan Linyuan Plastic Products Co., Ltd. | 2008-10-24 |
| ABC SYRINGE INFUSION PUMP, MODEL 4100 (K072603) | Elixir Corporation | 2008-10-23 |
| K-PACK II NEEDLE - 29G THIN WALL (K082820) | Terumo Europe N.V. | 2008-10-23 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K082822) | Zibo Zhuangyuan Plastic Products Company | 2008-10-22 |
| INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES (K081436) | Inviro Medical Devices, Inc. | 2008-10-22 |
| GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE (K083019) | Hospira, Inc. | 2008-10-22 |
| ALCOHOL PAD (K080466) | 122 Corporation | 2008-10-21 |
| NIPRO SAFETOUCH HUBER INFUSTION SET (K081210) | Nipro Medical Corp. | 2008-10-21 |
| 1ML UNITRACT INSULIN SYRINGE 27G*1/2 , 1ML UNITRACT SYRINGE 29G*1/2 (K080877) | Unilife Medical Solutions Limited | 2008-10-21 |
| MEDLINE POWDER-FREE NITRILE EXAMINATION GLOVE WITH ALOE (K081594) | Medline Industries, Inc. | 2008-10-17 |
| POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (K082370) | Smart Glove Corp. Sdn Bhd | 2008-10-17 |
| FIRMGRIP (K080793) | Flexicath , Ltd. | 2008-10-16 |
| MRDH BANDAGE (K082703) | Marine Polymer Technologies, Inc. | 2008-10-14 |
| DISPOSABLE VINYL EXAMINATION GLOVE, POWDER FREE (K082447) | Rich Mountain Medical Products, Inc. | 2008-10-14 |
| RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM (K082217) | Arizant Healthcare, Inc. | 2008-10-06 |
| ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) (K082106) | Elcam Medical Acal | 2008-10-02 |
| AUTO-SAFETY INJECTOR-2 (ASI-2) (K082587) | Medical House Products Limited | 2008-10-02 |
| COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT (K081425) | Cook Vascular, Inc. | 2008-09-30 |
| DISPOSABLE VINYL EXAMINATION GLOVE, POWDERED (K082444) | Rich Mountain Medical Products, Inc. | 2008-09-30 |
| POWDER-FREE VINYL EXAMINATION GLOVES (K081658) | Jiangsu Alfa Glove Co., Ltd. | 2008-09-30 |
| SECURACATH CATHETER, MODEL SPK01 (K082047) | Interrad Medical, Inc. | 2008-09-30 |
| QUICKPIN (K082752) | Laboratorios Grifols, S.A. | 2008-09-29 |
| HASELMEIER PEN 8 (K082616) | Haselmeier GmbH | 2008-09-26 |
| SYNTHETIC POWDER FREE (PINK) VINYL PATIENT EXAMINATION GLOVE (K082029) | Ever Light Plastic Products Co., Ltd. | 2008-09-26 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR (K081539) | Rich Mountain Medical Products, Inc. | 2008-09-26 |
| DISPOSABLE SYNTHETIC EXAMINATION GLOVES, POWDER FREE (K082443) | Rich Mountain Medical Products, Inc. | 2008-09-26 |
| SERIM DISINTEK OPA TEST STRIP (K082352) | Serim Research Corp. | 2008-09-25 |
| PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY) (K081904) | Medcomp | 2008-09-23 |
| SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TITANIUM, TRIUMPH LOW PROFILE TITANIUM PORTS (K081472) | AngioDynamics, Inc. | 2008-09-23 |
| SURSHIELD SAFETY I.V. CATHETER (K082362) | Terumo Medical Corp. | 2008-09-17 |
| INFRARED EAR THERMOMETER, MODEL ET-101A (K082192) | Sejoy Electronics & Instruments Co., Ltd. | 2008-09-17 |
| NON-STERILE, POWDERED LATEX EXAMINATION GLOVE (K081910) | Siam Sempermed Corp., Ltd. | 2008-09-17 |
| DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS (K081569) | Dynarex Corporation | 2008-09-12 |
| EFFECTIV (TM) CAP (K080579) | Hospira, Inc. | 2008-09-11 |
| VERSAPOD (TM) INSTRUMENT TRAYS (K071783) | Containmed, Inc. | 2008-09-09 |
| BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC (K081547) | Bio-Med USA, Inc. | 2008-09-08 |
| WEIGAO EMPTY CARTRIDGE SYRINGE (K081241) | Shandong Weigao Group Medical Polymer Co., Ltd. | 2008-09-08 |
| CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY (K080531) | Conmed Linvatec | 2008-09-05 |
| GONGDONG DISPOSABLE SHARP CONTAINER (K082042) | Zhejiang Gongdong Medical Plastic Factory | 2008-09-03 |
| NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) (K081907) | Siam Sempermed Corp., Ltd. | 2008-09-03 |
| RESERT XL HLD HIGH LEVEL DISINFECTANT (K080420) | STERIS Corporation | 2008-09-02 |
| D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP) (K081821) | Global Pathogen Solutions, Inc. | 2008-09-02 |
| POWERLOC CLEAR SAFETY INFUSION SET (K082306) | C.R. Bard, Inc. | 2008-08-28 |
| CENTURION PROTECTIVE RESTRAINT, SCR SERIES (K080448) | Tri-State Hospital Supply Corp. | 2008-08-28 |
| POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE (K081488) | Pt. Maja Agung Latexindo | 2008-08-28 |
| CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX (K081361) | Icu Medical, Inc. | 2008-08-28 |
| STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES (K081464) | Cardinalhealth | 2008-08-28 |
| STERIS RESERT XL TEST STRIP (K081600) | STERIS Corporation | 2008-08-22 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW) (K081657) | Jiangsu Cureguard Glove Co., Ltd. | 2008-08-20 |
| TRITON MEIDCAL TMED IV-SET (K073444) | Triton Medical, LLC | 2008-08-18 |
| AP 34 MULTI-THERAPY INFUSION PUMP (K082182) | Q-Core, Ltd. | 2008-08-15 |
| INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105 (K080136) | Steritec Products, Inc. | 2008-08-15 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR (K081535) | Rich Mountain Medical Products, Inc. | 2008-08-14 |
| UNASSIGNED (K080544) | Medcomp | 2008-08-14 |
| FORA COMFORTSCAN EAR THERMOMETER, MODELS TD-1261A; TD-1261B (K081445) | Taidoc Technology Corporation | 2008-08-11 |
| POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (PINK, BLACK, GREY, AND BLUE PEPPERMENT) (K081315) | Gx Corporation Sdn Bhd | 2008-08-11 |
| ANTIMICROBIAL ULTRASITE VALUE, ULTRASITE AG (K073396) | B.Braun Medical, Inc. | 2008-08-07 |
| ALATECH POWDERED LATEX PATIENT EXAMINATION GLOVE (K080606) | Alatech Healthcare, LLC | 2008-08-07 |
| EZ REGULAR (K080303) | Meinntech Co., Ltd. | 2008-08-05 |
| V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE (K081289) | Baxter Healthcare Corp | 2008-08-04 |
| SPSMEDICAL SPORVIEW PA CULTURE SET (K081879) | Spsmedical Supply Corp. | 2008-07-30 |
| STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (K081466) | Smart Glove Corp. Sdn Bhd | 2008-07-30 |
| COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS (K081113) | Cook, Inc. | 2008-07-30 |
| SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L (K081524) | Spectra Medical Devices, Inc. | 2008-07-29 |
| EXPRESS CHEST DRAIN (K081718) | Atrium Medical Corp. | 2008-07-25 |
| NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 (K081515) | Neomed, Inc. | 2008-07-21 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES (LIGHT YELLOW) (K081655) | Jiangsu Cureguard Glove Co., Ltd. | 2008-07-21 |
| CADD MEDICATION CASSETTE RESERVOIR (K081156) | Smiths Medical MD, Inc. | 2008-07-18 |
| HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-002 AND KINETIK BRANDED IET1 SERIES (K081061) | Harvard Medical Devices , Ltd. | 2008-07-18 |
| ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP (K081905) | Westmed, Inc. | 2008-07-15 |
| SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (K081690) | Cook, Inc. | 2008-07-14 |
| KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM (K081089) | Kimberly-Clark Corp. | 2008-07-14 |
| SERIM DISINTEK OPA TEST STRIP (K081370) | Serim Research Corp. | 2008-07-11 |
| KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES (K081260) | Kimberly-Clark Corp. | 2008-07-09 |
| MOBILE I.V. SYSTEMS 10,20,60 (K080695) | Northwind Technologies, Corp. | 2008-07-01 |
| KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE) (K081027) | Kimberly-Clark Corp. | 2008-06-30 |
| PRESSURE INJFECTABLE PICC (K080604) | Arrow International, Inc. | 2008-06-27 |
| ULTIMED ULTICARE SAFETY SYRINGE (K080600) | Ultimed, Inc. | 2008-06-25 |
| SYMPHONY GLUCOSE MANAGEMENT SYSTEM (K080639) | Animas Corp. | 2008-06-24 |
| AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES (K081160) | Avita Corporation | 2008-06-24 |
| SHARPS TRANSPORT TUBE, MODEL 50035 (K073577) | Sharps Compliance, Inc. | 2008-06-23 |
| OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500 (K081094) | Olympic Medical Corp. | 2008-06-20 |
| MICRO-TOUCH NITRAFREE (K080536) | Ansell Healthcare Products, LLC | 2008-06-19 |
| VACUETTE PREMIUM SAFETY NEEDLE SYSTEM (K072602) | Medpro Safety Products, Inc. | 2008-06-18 |
| MEDRAD INTEGO PET INFUSION SYSTEM (K080297) | Medrad, Inc. | 2008-06-17 |
| BROWNE OPA TEST STRIP (K081427) | STERIS Corporation | 2008-06-11 |
| NILIMEDIX ADI (K070844) | Nilimedix , Ltd. | 2008-06-06 |
| AVIATOR TRANSPORT INCUBATOR (K081399) | International Biomedical, Ltd. | 2008-06-06 |
| POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER (K081311) | C.R. Bard, Inc. | 2008-06-04 |
| FEEL-FINE INSULIN PEN NEEDLE (K080904) | Feel Tech | 2008-06-04 |
| ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER (K081449) | Ultimed, Inc. | 2008-06-03 |
| NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600, (K072080) | Smiths Medical Asd, Inc. | 2008-06-02 |
| TSO3 OZONE STERILIZATION WRAP (K080198) | Tso3, Inc. | 2008-05-30 |
| MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY (K073051) | Medrad, Inc. | 2008-05-30 |
| VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VH202 GASEOUS STERILIZATION PROCESSES (K073244) | STERIS Corporation | 2008-05-28 |
| WIRELESS BODY TEMPERATURE MONITOR, MODELS BTM-DIC, D, E, F, G AND H (K081256) | Rio Flexon Technology Co., Ltd. | 2008-05-27 |
| TARRY MEDICAL TEMPERATURE PROBES (K071977) | Tarry Medical Products, Inc. | 2008-05-23 |