| MODIFICATION TO: T-PORT HP INFUSION PORT (K073210) | Pfm Medical, Inc. | 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 |
| VERIFY V-PRO CHEMICAL INDICATOR, VERSIONS 1 AND 2 (K072510) | STERIS Corporation | 2007-12-11 |
| CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM (K072330) | Biomet, Inc. | 2007-12-06 |
| MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039 (K070705) | Vygon Corp. | 2007-11-30 |
| STERRAD 100NX STERILIZER (K071385) | Advanced Sterilization Products | 2007-11-29 |
| HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY (K072482) | Smiths Medical Asd, Inc. | 2007-11-29 |
| DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM (K072921) | Symbios Medical Products, LLC | 2007-11-26 |
| DISPENSER DP 20 (K071588) | NOUVAG AG | 2007-11-26 |
| PRO-PICC, BASIC TRAY; LONG WIRE TRAY; BASIC NURSING TRAY; FULL NURSING TRAY (K072509) | Medcomp | 2007-11-26 |
| MONOJECT HYPODERMIC NEEDLE, MODEL 250, 30 GAUGE HYPODERMIC NEEDLE (K073122) | Covidien Lp, Formerly Registered AS Tyco Healthcar | 2007-11-21 |
| YUYUAN LATEX EXAMINATION GLOVE, POWDERED (K072639) | Shandong Yuyuan Latex Gloves Company , Ltd. | 2007-11-19 |
| BRIO ACUPUNCTURE NEEDLES (K072778) | Helio Medical Supplies, Inc. | 2007-11-19 |
| PFM PICC (K072391) | Pfm Medical, Inc. | 2007-11-19 |
| SMARTSPONGE PLUS SYSTEM (K073180) | Clearcount Medical Solutions, Inc. | 2007-11-19 |
| VERIFY 275 DEGREE F. 3-10 INDICATOR; 10 INDICATOR; 3 INDICATOR (K071895) | STERIS Corporation | 2007-11-14 |
| TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER (K072549) | C.R. Bard, Inc. | 2007-11-14 |
| ADVANTIV SAFETY I.V. CATHETER (K072419) | Smiths Medical Asd, Inc. | 2007-11-09 |
| STERICAN HYPODERMIC NEEDLES (K072247) | B.Braun Medical, Inc. | 2007-11-08 |
| SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) (K072894) | Terumo Europe N.V. | 2007-11-06 |
| SMARTBLOCK PAIN PUMP (K072053) | Medical Flow Systems, Ltd. | 2007-11-06 |
| CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH THE CLEARLINK ANTIMICROBIAL LUER ACTIVATED (K072576) | Baxter Healthcare Corp | 2007-11-06 |
| V-CATH POLY PICC (K071875) | Hdc Corp. | 2007-11-05 |
| DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4. (K072641) | Famidoc Technology Co., Ltd. | 2007-11-01 |
| TITANIUM POWERPORT ISP IMPLANTED PORT (K072215) | C.R. Bard, Inc. | 2007-11-01 |
| GRIPPER MICRO NEEDLE (K072059) | Smiths Medical MD, Inc. | 2007-11-01 |
| ERBE ERBEJET 2 SYSTEM (K072404) | Erbe USA, Inc. | 2007-10-31 |
| Z-800 VOLUMETRIC INFUSION PUMP (K071545) | Zyno Medical, LLC | 2007-10-31 |
| BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1 (K072097) | Medical Select, Inc. | 2007-10-30 |
| DISPOSABLE VINYL EXAMINATION GLOVE, POWDERED (K072472) | Xuzhou Full Sun Medical Products , Ltd. | 2007-10-25 |
| LANFAN POWDER-FREE VINYL EXAM GLOVES (K072488) | Shanghai Lanfan Co., Ltd. | 2007-10-19 |
| MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305 (K070438) | Medtronic Minimed, Inc. | 2007-10-17 |
| T-PORT HP INFUSION PORT (K071993) | Pfm Medical, Inc. | 2007-10-17 |
| VIS-U-ALL II HEAT-SEAL POUCH AND TUBING (K071087) | STERIS Corporation | 2007-10-16 |
| SCM CATH ( SIZES ARE VARYING BETWEEN 16G X 2'' AND 24G X 3/4'' ), MODEL 1.50, 1.77,1.88',2, 1.25, 1.50, 1.77, (K071382) | Shinchang Medical Co., Ltd. | 2007-10-16 |
| DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR (K072401) | Xuzhou Full Sun Medical Products , Ltd. | 2007-10-15 |
| VIS-U-ALL II SELF SEAL POUCH (K070765) | STERIS Corporation | 2007-10-12 |
| VACU-MED BLOOD COLLECTION NEEDLES (K071947) | Shina Corp. | 2007-10-12 |
| SHARPS AWAY DISPOSABLE CONTAINER (K072667) | Solutions, Inc. | 2007-10-10 |
| BELIMED STEAM STERILIZER MODEL TOP 5000 SERIES 24 (K072087) | Belimed Sauter AG | 2007-10-05 |
| POWERPICC SOLO (K072230) | C.R. Bard, Inc. | 2007-10-05 |
| ICU MEDICAL SINGLE-USE SYRINGE (K070856) | Icu Medical, Inc. | 2007-10-05 |
| POLYPERF / POLYPERF SAFE (K063631) | Laboratoires Perouse | 2007-10-05 |
| VHP 136 TRAY (K070769) | STERIS Corporation | 2007-10-05 |
| POWRSYRINGE ASPIRATOR (K072299) | Pinyons Medical Technology, Inc. | 2007-10-04 |
| VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM (K062297) | STERIS Corporation | 2007-10-04 |
| PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET (K071421) | Promepla | 2007-10-04 |
| CHLORINATED POWDER FREE NITRILE LATEX EXAMINATION GLOVES (K071740) | Medtexx Manufacturing Sdn. Bhd. | 2007-10-04 |
| MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) (K072512) | Datex-Ohmeda, Inc. | 2007-10-03 |
| ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT (K071998) | Arrow Intl., Inc. | 2007-09-26 |
| DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES (K070339) | Cincinnati Sub-Zero Products, Inc. | 2007-09-26 |
| MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR (K072542) | Medegen Medical Manufacturing System | 2007-09-25 |
| TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM (K071741) | Migada Plant | 2007-09-24 |
| POWRSYRINGE INJECTOR (K072318) | Pinyons Medical Technology, Inc. | 2007-09-21 |
| MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX (K070291) | Medix I.C.S.A. | 2007-09-21 |
| POWRSYRINGE MONITOR (K072345) | Pinyons Medical Technology, Inc. | 2007-09-21 |
| AUTOSAFE-REFLEX SAFETY NEEDLE, AUTOSAFE ADVANTAGE SAFETY NEEDLE (K071567) | Autosafe-Refelx, Inc. | 2007-09-14 |
| POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH ALLOGEL (K071170) | Smart Glove Corp. Sdn Bhd | 2007-09-14 |
| GREINER VACUETTE QUICKSHIELD COMPLETE (K072320) | Greiner Bio-One North America, Inc. | 2007-09-14 |
| TRANS-CATHETER EXTRACTOR (K063048) | Tran Pa-C, Inc. | 2007-09-14 |
| MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT19S1R (K070590) | Microlife Intellectual Property GmbH | 2007-09-11 |
| FLEXWARMER, MODELS KZ-1 AND KZ-2 (K062644) | Merlyn Associates, Inc. | 2007-09-11 |
| NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK) (K071910) | Hartalega Sdn Bhd | 2007-09-06 |
| VERIFY CHALLENGE PACKS, MODELS 270F 4 CHALLENGE PACK; 275F 3 CHALLENGE PACK; 275F 10 CHALLENGE PACK (K070895) | STERIS Corporation | 2007-09-05 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K072085) | Zibo Hongye Shangqin Plastic Rubbert Co, Ltd. | 2007-09-04 |
| DANA 3CC SYRINGE INSULIN RESERVOIR (K071418) | Sooil Development Co., Ltd. | 2007-09-04 |
| OPACIDEN OPA REAGENT STRIPS (K070419) | Hach Company | 2007-08-31 |
| HEALTH LINE INTERNATIONAL CORPORATION'S PRIMARY IV SOLUTION ADMINISTRATION SET WITH CHECK VALVE (K070630) | Health Line International Corporation (Hlic) | 2007-08-31 |
| MODIFICATION TO THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES (K072108) | Tecnimed S.R.L. | 2007-08-31 |
| MODIFICATION TO EZ HUBER SAFETY INFUSION SET (K071846) | Pfm Medical, Inc. | 2007-08-30 |
| ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER (K071538) | Arrow International, Inc. | 2007-08-30 |
| SHANGHAI CHINA STAR CORP. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE (K071072) | Shanghai China Star Corp | 2007-08-30 |
| ANGIODYNAMICS, INC MORPHEUS PICC AND PROCEDURE KIT (K072196) | AngioDynamics, Inc. | 2007-08-27 |
| MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) (K072157) | Ohmeda Medical | 2007-08-27 |
| SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G) (K070988) | Shinchang Medical Co., Ltd. | 2007-08-23 |
| SMALL VOLUME SYRINGE (K062865) | Alcon Laboratories | 2007-08-23 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES (K071686) | Langfang Huilong Plastic Product Co., Ltd. | 2007-08-22 |
| R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,005 (K071361) | R4 Vascular, Inc. | 2007-08-20 |
| BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER (K070002) | Boston Scientific | 2007-08-17 |
| CRYOSEAL FS APPLICATOR SYSTEM (K071126) | Thermogenesis Corp. | 2007-08-16 |
| COMCASET-P SAFETY IV CATHETER (K070020) | Pitango Medical, Ltd. | 2007-08-16 |
| B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES (K071459) | B.Braun Medical, Inc. | 2007-08-16 |
| HEATMARKER TIME TEMPERATURE INDICATOR (K063759) | Temptime Corporation | 2007-08-15 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K072001) | Tangshan Hongyun Plastic Products Co., Ltd. | 2007-08-15 |
| STD MED PRIMO PORT (K070911) | Std Med, Inc. | 2007-08-10 |
| CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML (K072037) | Life-Shield Products, Inc. | 2007-08-08 |
| MASTER GUARD NITRILE BLUE POWDERED EXAMINATION GLOVES (K071207) | High Momentum Sdn Bhd | 2007-08-07 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K071685) | Langfang Huilong Plastic Product Co., Ltd. | 2007-08-06 |
| LULLABY (K071828) | Ge Healthcare Clinical Systems | 2007-08-06 |
| SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC (K070117) | Dolomite Biotech Sdn Bhd | 2007-08-06 |
| SWABBABLE CAP, MODEL 60205 (K070163) | Baxa Corp. | 2007-08-03 |
| HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE (K071785) | Smiths Medical Asd, Inc. | 2007-08-02 |
| OPACIDEN SOLUTION (K070627) | Ciden Technologies, LLC | 2007-08-02 |
| ABLE CENTRAL VENOUS CATHETER (K070451) | Foshan Nanhai Bai HE Medical Technology Co., Ltd. | 2007-07-31 |
| DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR (K071123) | Xuzhou Full Sun Medical Products , Ltd. | 2007-07-30 |
| MASTER GUARD NITRILE BLUE POWDER FREE EXAMINATION GLOVES (K071208) | High Momentum Sdn Bhd | 2007-07-30 |
| NON-STERILE, LATEX POWDER FREE PATIENT EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE) (K071060) | Sgmp Co., Ltd. | 2007-07-26 |
| MASTER GUARD LATEX POWDER FREE EXAMINATION GLOVES (K071209) | High Momentum Sdn Bhd | 2007-07-25 |
| POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE, WHITE) (K071119) | Gx Corporation Sdn Bhd | 2007-07-24 |
| TRIBOGLIDE LUBRICATED SILICONE-FREE SYRINGE (K071027) | Tribofilm Research, Inc. | 2007-07-20 |