| ULTRA SEAL STERILE LUBRICATING JELLY (K101522) | Ultra Seal Corporation | 2010-12-23 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K102817) | Hebei Hongtai Plastic Products Co., Ltd. | 2010-12-23 |
| AUDIT MICROCV HS-CRP LINEARITY SET (K101427) | Aalto Scientific, Ltd. | 2010-12-23 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K102819) | Hebei Hongtai Plastic Products Co., Ltd. | 2010-12-23 |
| MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE (K101782) | Staar Japan | 2010-12-22 |
| OSOM C. DIFFICILE TOXIN A/B TEST (K102242) | Genzyme Corporation | 2010-12-21 |
| LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS (K102700) | Alere, San Diego, Dba Biosite INcorporated, Dba IN | 2010-12-21 |
| SYNTHETIC, POWDER-FREE NITRILE EXAMINATION (K102593) | Zibo Yinghao Medical Products Co., Ltd. | 2010-12-20 |
| SUNMAX VIETNAM CO. LTD POWDER FREE WHITE NITRILE EXAMINATION GLOVE (K101870) | Sunmax Vietnam Co., Ltd. | 2010-12-20 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K102977) | Heze Juxinyuan Food Co., Ltd. | 2010-12-20 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K103198) | Youngshengplastic Co., Ltd. | 2010-12-20 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K102724) | Zibo Yuqun New Material Science and Technology CO | 2010-12-20 |
| SMARTO (K101563) | Jeil Medical Corporation | 2010-12-17 |
| NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUG LABELING CLAIM (K103249) | Cardinal Health, Inc. | 2010-12-16 |
| GSP NEONATAL IRT KIT (3306-001U) (K102419) | Wallac Oy, Subsidiary of Perkinelmer | 2010-12-16 |
| GNR TRAFFIC LIGHT PNA FISH (K101558) | Advandx, Inc. | 2010-12-16 |
| POWDERED VINYL PATIENT EXAMINIATION GLOVES, CLEAR (NON-COLORED) (K102976) | Heze Juxinyuan Food Co., Ltd. | 2010-12-13 |
| TREVAIR CHAIR ADULT (K102061) | Patmont Motor Werks, Inc. | 2010-12-13 |
| PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399 (K100854) | Premium Plus International Limited | 2010-12-09 |
| SELF RETAINING SOFT TISSUE RETRACTOR (K101609) | Koros USA, Inc. | 2010-12-09 |
| SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM (K103340) | Harvest Technologies, Corp. | 2010-12-06 |
| PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH (K103099) | Roche Diagnostics | 2010-12-06 |
| BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES (K100785) | Bonart Co., Ltd. | 2010-12-03 |
| BOSWORTH AIR POLISHER (K100731) | Harry J. Bosworth Co. | 2010-12-03 |
| BRAVO PH MONITORING SYSTEM AND ACCESSORIES (K102543) | Given Imaging , Ltd. | 2010-12-01 |
| VITALA CONTINENCE CONTROL DEVICE (K102536) | Convatec, Inc. | 2010-12-01 |
| POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG (K102790) | Perusahaan Getah Asas Sdn. Bhd. | 2010-11-29 |
| A-DEC 200 DENTAL SYSTEM (K102234) | A-Dec, Inc. | 2010-11-24 |
| ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL (K102904) | Siemens Healthcare Diagnostics | 2010-11-23 |
| BIOGEL ORTHOPRO INDICATOR UNDERGLOVE (K101163) | Molnlycke Health Care USA | 2010-11-23 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K102444) | Zibo Yingbo Medical Products, Inc. | 2010-11-22 |
| POWDERFREE BLACK NITRILE EXAMINATION GLOVES (K102620) | Pt. Medisafe Technologies | 2010-11-22 |
| BRIGHTWAY TM BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE. (GREY COLOR) (K102880) | Brightway Holdings Sdn. Bhd. | 2010-11-19 |
| NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K101822) | Sgmp Co., Ltd. | 2010-11-19 |
| ELECSYS PTH CALCHECK 5 (K103162) | Roche Diagnostics | 2010-11-18 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K102097) | Shijiazhuang Great Vision Plastic Products Co., LT | 2010-11-17 |
| PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) (K101436) | Shen Wei (Usa), Inc. | 2010-11-17 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K102171) | Wuxi Bingfa Gainlite Gloves Cp., Ltd. | 2010-11-16 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE) (K102558) | Tangshan Hengda Plastic Products Co., Ltd. | 2010-11-12 |
| POWDERED, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEP1 (K101106) | Best Putra Gloves Sdn Bhd | 2010-11-10 |
| POWDER-FREE, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEPF1 (K101105) | Best Putra Gloves Sdn Bhd | 2010-11-10 |
| SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (K102337) | Curon Scientific Co., Ltd. | 2010-11-08 |
| SYNTHETIC, POWDER-FREE NITRILE EXAMINATION GLOVES (K101943) | Tangshan Jiteng Plastic Products Co., Ltd. | 2010-11-08 |
| HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) (K101538) | Philips Electronics UK Limited | 2010-11-05 |
| STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING (K102500) | Cardinal Health, Inc. | 2010-11-04 |
| DISCOVERY NM 750B (K102231) | Ge Medical Systems Israel, Functional Imaging | 2010-11-03 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K102093) | Shijiazhuang Great Vision Plastic Products Co., LT | 2010-11-03 |
| POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, BLUE (SG) (K102074) | Gx Corporation Sdn Bhd | 2010-11-02 |
| ELECSYS CA 125 II CALCHECK 5 (K102086) | Roche Diagnostics | 2010-11-01 |
| COMFORT RUBBER GLOVES IND.SDN.BHD. (K101917) | Comfort Rubber Gloves Industries Sdn. Bhd. | 2010-10-29 |
| POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA (YELLOW, WHITE, BLUE) (K102655) | Ever Light Plastic Products Co., Ltd. | 2010-10-29 |
| 24 WIDEN WHEELCHAIR (JY/CT-H28), 18 RECLINING WHEELCHAIR (JY-260), 18 LIGHT WEIGHT WHEELCHAIR (JY/CT-H06), 18 ALUMIN (K102110) | Foshan Shunde Jaeyong Hardware Co., Ltd. | 2010-10-26 |
| DENTACENTER/EXPEDITION, MODEL SAF-430 (K100212) | Safari Dental, Inc. | 2010-10-22 |
| XPRESS BALLOON DEVICE (K102003) | Entellus Medical, Inc. | 2010-10-22 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K102611) | Shijiazhuang Hyland Plastic Co., Ltd. | 2010-10-21 |
| REMIN PRO (K101104) | Voco GmbH | 2010-10-21 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) (K102570) | Tangshan Kangjie Glove Co., Ltd. | 2010-10-21 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) (K102569) | Tangshan Kangyuan Glove Co., Ltd. | 2010-10-21 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) (K102559) | Tangshan Hengda Plastic Products Co., Ltd. | 2010-10-21 |
| GALAXY LITE (K102031) | Future Mobility Healthcare, Inc. | 2010-10-20 |
| NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT (K101351) | Ascend Eagle, Inc. | 2010-10-15 |
| PROTEGRITY SMT LATEX SURGICALGLOVES (K101811) | Cardinal Health, Inc. | 2010-10-15 |
| REL-K ARTIFICAL LIMB PROSTHESIS (K101859) | Rizzoli Ortopedica S.P.A. | 2010-10-13 |
| BLUE SAIL INNOVATION (K102161) | Shandong Blue Sail Innovation Co., Ltd. | 2010-10-08 |
| POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE (K101594) | Better Care Plastic Technology Cp., Ltd. | 2010-10-08 |
| ELECSYS IGE CALCHECK 5 (K102269) | Roche Diagnostics | 2010-10-07 |
| ELEGANT BLUE, WHITE, PINK POWDER FREE, NITRILE EXAMINATION GLOVES (K101760) | Profit Point Manufacturing Sdn Bhd | 2010-10-06 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K102099) | Hong DI Plastic Products Co., Ltd. | 2010-10-06 |
| GRAND WORK PLASTIC PRODUCTS CO., LTD. POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K102089) | Grand Work Plastic Products Co., Ltd. | 2010-10-06 |
| ELECSYS CA 19-9 CALCHECK 5 (K101365) | Roche Diagnostics Corp. | 2010-10-05 |
| ELECSYS CEA CALCHECK 5 (K101856) | Roche Diagnostics | 2010-10-05 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K102094) | Grand Work Plastic Products Co., Ltd. | 2010-10-05 |
| FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20 (K101809) | Fujirebio Diagnostics,Inc. | 2010-10-05 |
| STRETCH VINYL EXAMINATION GLOVE POWDER FREE (K102160) | Shandong Blue Sail Innovation Co., Ltd. | 2010-10-04 |
| KAIYANG ALUMINUM WHEELCHAIR (K101998) | Guangdong Kaiyang Medical Technology Co., Ltd. | 2010-10-04 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K102362) | Jiangsu Huayuan Gloves Co., Ltd. | 2010-10-04 |
| KAIYANG STEEL WHEELCHAIR (K101999) | Guangdong Kaiyang Medical Technology Co., Ltd. | 2010-10-04 |
| POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (K102096) | Syntex Healthcare Products Co., Ltd. | 2010-10-04 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K102431) | Tangshan Fuqiang Glove Co., Ltd. | 2010-10-04 |
| POWDER FREE LATEX EXAMINATION GLOVES (18 ML), BLUE TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K101828) | Gx Corporation Sdn Bhd | 2010-10-04 |
| CRIT-LINE ANEMIA MANAGEMENT SOFTWARE (K093834) | Hema Metrics, LLC | 2010-09-29 |
| POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC (K100550) | Polymedco, Inc. | 2010-09-28 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K100421) | Tangshan Yonkshun Glove, Co., Ltd. | 2010-09-27 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K102098) | Hong DI Plastic Products Co., Ltd. | 2010-09-27 |
| QUICKVUE RSV 10 (K101918) | Quidel Corp. | 2010-09-24 |
| FDI GLUCOSE CONTROL SOLUTIONS (K102260) | Fujirebio Diagnostics,Inc. | 2010-09-24 |
| LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK (K100727) | Bio-Rad, Diagnostics Grp. | 2010-09-14 |
| NUGARD NITILE GREY COLOR (K102230) | Terang Nusa Sdn Bhd | 2010-09-10 |
| ELECSYS FERRITIN CALCHECK 5 (K102267) | Roche Diagnostics | 2010-09-10 |
| PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M (K101551) | Delma Medical Instrument (Guangzhou) Co., Ltd. | 2010-09-09 |
| KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS (K102032) | Kimberly-Clark Corp. | 2010-09-08 |
| NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR (K101646) | Sgmp Co., Ltd. | 2010-09-08 |
| POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE (K101630) | Pt. Smartglove Indonesia | 2010-09-07 |
| POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE (K101799) | Wear Safe (Malaysia) Sdn. Bhd. | 2010-09-03 |
| AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5 (K100718) | Aalto Scientific, Ltd. | 2010-09-03 |
| PRECICONTROL CLINCHEM MULTI 1 AND 2 (K102016) | Roche Diagnostics | 2010-09-01 |
| ELECSYS DIGOXIN CALCHECK 5 (K102044) | Roche Diagnostics | 2010-08-31 |
| AUDIT MICROCV RF/CRP LINEARITY SET (K101226) | Aalto Scientific, Ltd. | 2010-08-31 |
| ELECSYS PRECICONTROL MULTIMARKER (K102157) | Roche Diagnostics | 2010-08-27 |
| NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH (K101633) | Nova Biomedical Corp. | 2010-08-27 |