| ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS (K123561) | Bsn Medical, Inc. | 2012-12-18 |
| DR. SCHOLL'S COMPRESSION SOCKS (K123398) | Renfro Corporation | 2012-12-18 |
| CATHETER CONNECTIONS DUALCAP SOLO (K123065) | Catheter Connections, Inc. | 2012-12-14 |
| STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE (K122555) | Steritec Products Mfg Co, Inc. | 2012-12-12 |
| VASU-PICC (K122423) | Medical Components, Inc. | 2012-12-12 |
| POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE (K122874) | Nitrilist Gloves Manufacturing Sdn Bhd | 2012-12-10 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) (K122828) | Shandong Hongxin Chemicals Co., Ltd. | 2012-12-10 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) (K122835) | Yuanhang Plastic Co., Ltd. | 2012-12-10 |
| OMNIPOD INSULIN MANAGMENT SYSTEM (K122953) | Insulet Corporation | 2012-12-07 |
| COMFORT EZ (K122787) | Simple Diagnostics, Inc. | 2012-12-06 |
| POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K122999) | Top Glove Sdn. Bhd. | 2012-11-30 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) (K122893) | Geenli Plastic Co, Ltd. | 2012-11-30 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) (K122920) | Hebei Leader Plastic Co., Ltd. | 2012-11-30 |
| ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC) (K121501) | Arrow International (Subsidiary of Teleflex Inc.) | 2012-11-29 |
| ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER (K121775) | Vital Signs, Inc., A GE Healthcare Company | 2012-11-28 |
| CUROS TIP (K121171) | Ivera Medical, Inc. | 2012-11-26 |
| POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES (K121811) | Shen Wei (Usa), Inc. | 2012-11-21 |
| NON-CONTACT THERMOMETER (K120711) | K-Jump Health Co., Ltd. | 2012-11-19 |
| ACCU-CHEK ULTRAFLEX INFUSION SET (K122686) | Roche Diabetes Care AG | 2012-11-16 |
| POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL (K120066) | Kossan Latex Industries(M)Sdn Bhd | 2012-11-16 |
| TEXTURED, BLUE, LATEX, POWDER FREE EXAMINATION GLVOES, WITH PROTEIN LABELING CLAIM (50UG/DM OR LESS OF WATER SOLUBLE PRO (K123026) | Northstar Healthcare Holdings | 2012-11-16 |
| POWERPORT CLEARVUE SLIM IMPLANTABLE PORT (K122899) | C.R. Bard, Inc. | 2012-11-15 |
| REGEN SPRAY APPLICATOR, (K122122) | Regen Lab SA | 2012-11-09 |
| TERUMO(R) NEEDLE (K121607) | Terumo (Philippines) Corporation | 2012-11-08 |
| DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER) (K122912) | Hangzhou Hua'An Medical & Health Instruments Co., | 2012-11-07 |
| BLUE POWDERED NITRILE EXAMINATION GLOVE (K122998) | Northstar Healthcare Holdings | 2012-11-06 |
| NYLUS PICC (K113225) | Semprus Biosciences | 2012-11-06 |
| RESUSCITAIRE WITH AUTOBREATH (K120642) | Draeger Medical Systems, Inc. | 2012-11-02 |
| SURFFLASH(R) PLUS SAFETY I.V. CATHETER (K123267) | Kofu Factory of Terumo Corp. | 2012-11-02 |
| NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) (K122215) | Carticept Medical, Inc. | 2012-10-26 |
| AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE (K121637) | Sunwell Biotech Co., Ltd. | 2012-10-25 |
| COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE) (K121594) | Tekmedic (M) Sdn Bhd | 2012-10-25 |
| CLICKFINE PEN NEEDLE (K122969) | P/L Biomedical | 2012-10-25 |
| CLICKFINE PEN NEEDLE (K122971) | P/L Biomedical | 2012-10-25 |
| 3M ATTEST(TM) SUPER RAPID READOUT BIOLOGICAL INDICATOR, 3M ATTEST(TM) AUTO-READER (K121484) | 3M Company | 2012-10-19 |
| NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE (K113469) | Nipro Medical Corporation | 2012-10-18 |
| NMI HPICC III (K122882) | Navilyst Medical, Inc. | 2012-10-18 |
| NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET (K113471) | Nipro Medical Corporation | 2012-10-18 |
| STERILE BLUNT FOR SINGLE USE (K120420) | Shanghai Double Dove Industrial Co., Ltd. | 2012-10-18 |
| NIPRO SAFE TOUCH HUBER INFUSION SET (K113470) | Nipro Medical Corporation | 2012-10-17 |
| GLOBAL MEDI PRODUCTS RETRACTABLE SAFETY SYRINGE (K120641) | Global Medi Products | 2012-10-17 |
| POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY) (K122131) | Matang Mfg. Sdn. Bhd. | 2012-10-17 |
| THS INSTRUMENT TRAY (K120947) | Hologic, Inc. | 2012-10-17 |
| POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR (K121992) | Xinwei (Shandong) Plastic and Rubber Products Co., | 2012-10-16 |
| MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, PINK (K122465) | Industrial Clothings, Ltd. | 2012-10-16 |
| TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS (K112087) | Advanced Sterilization Products | 2012-10-15 |
| AUTOJECT 2 FOR GLASSY SYRINGE (K122837) | Owen Mumford, Ltd. | 2012-10-15 |
| RAPICIDE OPA-28 TEST STRIP (K120652) | Serim Research Corp. | 2012-10-12 |
| FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY) (K121591) | Tekmedic (M) Sdn Bhd | 2012-10-11 |
| WIRELESS THERMOMETER (K121696) | Raling Medical Company | 2012-10-11 |
| STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR (K122044) | Advanced Sterilization Products | 2012-10-04 |
| ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET (K120110) | Profit Point Manufacturing Sdn Bhd | 2012-10-04 |
| MIXJECT WITH SPRAY HEAD (K122023) | Medimop Medical Projects, Ltd. | 2012-10-04 |
| HT-WEDGE (K121287) | D.T. Davis Enterprises Ltd. T/A Hovertech Int'L | 2012-10-03 |
| STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202 (K111519) | Advanced Sterilization Products | 2012-10-03 |
| STERRAD CHEMIAL INDICATOR STRIP MODEL 14100 (K111518) | Advanced Sterilization Products | 2012-10-03 |
| GIRAFFE AND PANDA WARMERS (K122267) | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2012-10-02 |
| 14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE (K122263) | Symmetry Medical | 2012-09-28 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K122266) | Shandong Junfeng Industries Co., Ltd. | 2012-09-27 |
| RAPICIDE OPA-28 (K120306) | Minntech Corp. | 2012-09-27 |
| DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATION (K122507) | Cardinal Health200, LLC | 2012-09-26 |
| STERRAD (R) 100NX DUO CYCLE TEST PACK (K111391) | Advanced Sterilization Products | 2012-09-26 |
| ULTRASAFE PASSIVE NEEDLE GUARD (K122558) | Safety Syringes, Inc. | 2012-09-20 |
| NEOMED ORAL/ENTERAL SYRINGE (K122373) | Neomed, Inc. | 2012-09-20 |
| BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM (K121926) | Northstar Healthcare Holdings | 2012-09-20 |
| CG+ ARROW PICC POWERED BY ARROW VPS STYLET (K122545) | Arrow International (Subsidiary of Teleflex Inc.) | 2012-09-20 |
| MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY (K121262) | Medefil, Inc. | 2012-09-20 |
| POWER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) (K120968) | Tangshan Zhonghong Pulin Plastic Co.,Ltd | 2012-09-19 |
| DIGNITY POWER INJECTABLE TITANIUM PORT (K120281) | Medical Components, Inc. | 2012-09-17 |
| STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR (K111375) | Advanced Sterilization Products | 2012-09-14 |
| LULLABY TM WARMER (K121625) | Wipro GE Healthcare Private, Ltd. | 2012-09-14 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVE (K112741) | Lifestyle Safty Products (Hui Zhou) Co., Ltd. | 2012-09-13 |
| STERRAD(R) 100NX STERILIZER DUO CYCLE (K111377) | Advanced Sterilization Products | 2012-09-13 |
| PROTECTOR, INJECTOR, CONNECTOR (K120384) | Bd Medical-Medical Surgical Systems | 2012-09-12 |
| NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES (K112693) | Sgmp Co., Ltd. | 2012-09-12 |
| POWDER FREE BLACK NITRILE EXAMINATION GLOVES (K113393) | Tg Medical Sdn. Bhd. | 2012-09-11 |
| POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR (K121528) | Shen Wei (Usa), Inc. | 2012-09-11 |
| ETS BLUE POWDER-FREE PATIENT NITRILE EXAMINATION GLOVES (K121947) | Northstar Healthcare Holdings | 2012-09-10 |
| NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (K122363) | Siam Sempermed Corp., Ltd. | 2012-09-10 |
| INFRARED THERMOMETER (K113761) | Famidoc Technology Co., Ltd. | 2012-09-07 |
| ARROW PICC POWERED BY ARROW VPS STYLET (K121941) | Arrow International (Subsidiary of Teleflex Inc.) | 2012-09-07 |
| ZYNO MEDICAL ADMINISTRATION SET (K120685) | Zyno Medical, LLC | 2012-09-07 |
| TERUMO SURFLASH SAFETY I.V. CATHETER (K122544) | Terumo Corporation | 2012-09-05 |
| INFILL GRAFT DELIVERY SYSTEM (K121476) | Pinnacle Spine Group, LLC | 2012-08-29 |
| TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE (K122249) | Terumo (Philippines) Corporation | 2012-08-28 |
| ARJORAD STERILE WRAP (K110954) | Arjo Wiggins Medical, Inc. | 2012-08-24 |
| (MULTIPLE) DIGITAL THERMOMETER (K120004) | China Shenyang Med-Land Imp/Exp Corp., Ltd. | 2012-08-23 |
| NMI PICC III (K121089) | Navilyst Medical, Inc. | 2012-08-23 |
| HY-CHLO(TM)WOUND SCRUB (K113312) | Patrin Pharma | 2012-08-21 |
| POWDER-FREE NITRIE EXAMINATION GLOVES, ORANGE (K120890) | Shen Wei (Usa), Inc. | 2012-08-17 |
| VIALOK SINGLE VIAL ACCESS DEVICE VENTED (K122265) | Yukon Medical, LLC | 2012-08-14 |
| LUBE JELLY SURINGE (K121390) | Nurse Assist, Inc. | 2012-08-10 |
| COMFORT EZ (K121632) | Simple Diagnostics, Inc. | 2012-08-10 |
| NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE) (K121368) | Matang Mfg. Sdn. Bhd. | 2012-08-10 |
| POWDER FREE LATEX EXAMINATION GLOVES (K113685) | Khai Hoan Joint Stock Company | 2012-08-10 |
| FLASHPAK (K113776) | Symmetry Medical | 2012-08-08 |
| NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK) (K121192) | Tekmedic (M) Sdn Bhd | 2012-08-03 |
| POWER-FREE NITRILE PATIENT EXAMINATION GLOVES (K121526) | Shandong Junchi Medical Products Co., Ltd. | 2012-08-03 |
| PICC CONVENIENCE KIT (K121990) | Navilyst Medical, Inc. | 2012-08-03 |
| MYSAFETY SYRINGE (K113673) | Medicalchain Internartional Corporation | 2012-08-03 |