| CENTURY MODEL 105C (K093341) | Sybron Dental Specialties, Inc. | 2010-04-05 |
| COBAS U411 TEST SYSTEM (K093555) | Roche Diagnostics | 2010-04-02 |
| PROXISCAN MODEL 101 (K093706) | Hybridyne Imaging Technologies, Inc. | 2010-04-02 |
| VITALA CONTINENCE CONTROL DEVICE (K083785) | Convatec | 2010-04-02 |
| ELECSYS TROPONIN I CALCHECK 5 (K100594) | Roche Diagnostics | 2010-04-01 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K100337) | Tangshan Qixin Glove Co., Ltd. | 2010-03-29 |
| ELECSYS CK-MB CALCHECK 5 (K093582) | Roche Diagnostics | 2010-03-29 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K100324) | Tangshan Hengtong Plastic Products Co. | 2010-03-29 |
| MULTIPLE PRIVATE LABEL (K100162) | Biogreen Yields Sdn.Bhd | 2010-03-24 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K100326) | Tangshan Hongda Plastci Products Co, Ltd. | 2010-03-24 |
| 18 STANDARD WHEELCHAIR, MODEL MS005-4, 18 RECLINING WHEELCHAIR , MODEL MS008-1, 14 PEDIATRIC WHEELCHAIR (K094047) | Modern Rehabilitation Solutions Co., Ltd. | 2010-03-22 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K100339) | Tangshan Changrong Glove Co., Ltd. | 2010-03-22 |
| ELECSYS TROPONIN T CALCHECK 5 (K092848) | Roche Diagnostics Corp. | 2010-03-19 |
| MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR (K093492) | Diamond Diagnostics, Inc. | 2010-03-19 |
| C. ALBICANS/C. GLABRATA PNA FISH (K092784) | Advandx, Inc. | 2010-03-12 |
| GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES (K093213) | Carl Zeiss Meditec, Inc. | 2010-03-12 |
| LIQUICHEK OPIATE CONTROL (K093577) | Bio-Rad Laboratories | 2010-03-12 |
| MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3) (K093384) | Diamond Diagnostics, Inc. | 2010-03-10 |
| POC-AS10 AUTO SAMPLER (K092817) | Otsuka Pharmaceutical Co., Ltd. | 2010-03-09 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) (K100058) | Tangshan Zhongpu Plastic Products Co., Ltd. | 2010-03-05 |
| RUBBER-LIKE POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR (K093576) | Jiangsu Cureguard Glove Co., Ltd. | 2010-03-04 |
| MICRO-TOUCH NITRILE (K093523) | Ansell Healthcare Products, LLC | 2010-03-04 |
| ELECSYS HCG STAT CALCHECK 5 (K093700) | Roche Diagnostics Corp. | 2010-03-04 |
| MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER (K093594) | Acclarent, Inc. | 2010-03-03 |
| ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE (K093894) | Anthogyr | 2010-03-03 |
| ANAPNOGUARD ENDOTRACHEAL TUBE (K093126) | Hospitech Respiration , Ltd. | 2010-03-02 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) (K100074) | Tangshan Jiteng Plastic Products Co., Ltd. | 2010-02-26 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE) (K100075) | Tangshan Jiteng Plastic Products Co., Ltd. | 2010-02-26 |
| SKIN BARRIER FILM (K092712) | Lodestar Products, Inc. | 2010-02-23 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVE (K093798) | Supermax Plastic Products Co., Ltd. | 2010-02-23 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES (YELLOW, WHITE) (K093797) | Supermax Plastic Products Co., Ltd. | 2010-02-23 |
| POWDERED LATEX EXAMINATION GLOVES, NON-STERILE (K092681) | Khai Hoan Joint Stock Company | 2010-02-23 |
| ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003 (K093718) | Zutron Medical, LLC | 2010-02-22 |
| MEDIGUARD NITRILE EXAMINATION GLOVE- BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) (K093726) | Medline Industries, Inc. | 2010-02-22 |
| MULTIPLE NAME MODEL MULTIPLE (K093759) | Gx Corporation Sdn Bhd (Plant 1) | 2010-02-19 |
| SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803 (K093696) | Central Medicare Sdn Bhd | 2010-02-12 |
| ENTELLUS MEDICAL BALLOON DEVICE (K093007) | Entellus Medical, Inc. | 2010-02-05 |
| STRONG DENTAL HANDPIECES (K100192) | Saeshin Precision Co., Ltd. | 2010-02-04 |
| NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVES WITH AND/OR WITHOUT STRAWBERRY SCENT AND WITH PROTEIN CONTENT (K093496) | Oon Corp. Resources | 2010-02-03 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLO COLOR (K093727) | Zibo Bolin Gloves Co., Ltd. | 2010-02-01 |
| MISSION BREATH ALCOHOL DETECTOR (K093143) | ACON Laboratories, Inc. | 2010-01-28 |
| C. ALBICANS PNA FISH (K092655) | Advandx, Inc. | 2010-01-19 |
| POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE (K093500) | Wear Safe (Malaysia) Sdn. Bhd. | 2010-01-19 |
| SAF (SELF ADJUSTING FILE) (K092933) | Redent-Nova , Ltd. | 2010-01-14 |
| ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773 (K091867) | Siemens Healthcare Diagnostics | 2010-01-14 |
| ENDOMAX CORDLESS ENDODONTIC HANDPIECE (K092833) | Dentamerica | 2010-01-07 |
| STARCARE HANDPIECE MAINTENANCE UNIT (K093072) | Dentalez, Inc. | 2009-12-28 |
| STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K091851) | Gx Corporation Sdn Bhd | 2009-12-28 |
| FORESEE HOME (K091579) | Notal Vision , Ltd. | 2009-12-23 |
| D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT (K093415) | Diagnostic Hybrids, Inc. | 2009-12-23 |
| AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM (K093098) | Arkray, Inc. | 2009-12-23 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K093439) | Tangshan Pufa Plastic Products Co., Ltd. | 2009-12-22 |
| SMARTWAND-DTX (K093557) | Clearcount Medical Solutions | 2009-12-18 |
| DYNAREX STERILE LUBRICATING JELLY (K092488) | Dynarex Corporation | 2009-12-18 |
| ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP (K093084) | Rolence Ent., Inc. | 2009-12-16 |
| E.COLI/P. AERUGINOSA PNA FISH (K092236) | Advandx, Inc. | 2009-12-16 |
| BINAXNOX STAPHYLOCOCCUS AUREUS TEST (K090964) | Binax, Inc. | 2009-12-16 |
| LOUSEBUSTER (K093144) | Larada Sciences | 2009-12-16 |
| ELECSYS PROBNP II CALCHECK 5 (K092169) | Roche Diagnostics | 2009-12-16 |
| CHIROPRO L SYSTEM (K092214) | Bien-Air Dental, SA | 2009-12-15 |
| CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR (K090931) | W&H Dentalwerk Buermoos GmbH | 2009-12-15 |
| SPECTRA MEDICAL SAFETY SCAPEL (K091462) | Spectra, Inc. | 2009-12-15 |
| SPOTCHECK BLOOD SPOT CONTROL, ASSAYED (K090940) | Astoria-Pacific, Inc. | 2009-12-14 |
| LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913 (K093498) | DiaSorin, Inc. | 2009-12-14 |
| GAMMALOC SYSTEM, MODEL 03-00001 (K082588) | Dilon Technologies, LLC | 2009-12-11 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K092966) | Jin Zhou Chang Hao Plastic Products Co., Ltd. | 2009-12-08 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K092956) | Shandong Aobo Medical Co, Ltd. | 2009-12-04 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR (K093570) | Jiangsu Jaysun Glove Co., Ltd. | 2009-12-04 |
| RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18 (K091507) | Rayner Intraocular Lenses , Ltd. | 2009-12-04 |
| MAS AND MINI-TROL PTH CONTROL (K092749) | Microgenics Corporation | 2009-12-03 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K092820) | Shijiazhuang Fuhao Plastic Products Co., Ltd. | 2009-12-03 |
| X-SMART EASY (K092614) | Dentsply Interntional | 2009-12-02 |
| INSERTEASE (K092829) | Christcot Medical Company | 2009-12-02 |
| KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS) (K093375) | Koon Seng Sdn Bhd | 2009-12-02 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K093277) | Tangshan Green Healthcare Co., Ltd. | 2009-11-30 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K093272) | Tangshan Huamei Healthcare Co., Ltd. | 2009-11-30 |
| POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES (K092160) | Comfort Rubber Gloves Ind. Sdn. Bhd. | 2009-11-27 |
| POWDER FREE NITRILE EXAMINATION GLOVES BLACK; BLUE, GRAPE SCENTED (K091965) | Platinum Glove Industries Sdn. Bhd. | 2009-11-24 |
| S. AUREUS/CNS PNA FISH, MODEL KT005 (K092166) | Advandx, Inc. | 2009-11-23 |
| LAGLOVE BRAND COLORED LATEX EXAMINATION GLOVES POWDERED, NON-STERILE (PINK/GREEN/VIOLET) (K092499) | La Glove (M) Sdn. Bhd. | 2009-11-20 |
| ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL (K092993) | Siemens Healthcare Diagnostics | 2009-11-20 |
| LAGLOVE BRAND NITRILE EXAMINATION GLOVES POWDERED, NON STERILE (PINK COLOR) (K092498) | La Glove (M) Sdn. Bhd. | 2009-11-20 |
| ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579 (K091714) | Skyfine Inc. Limited | 2009-11-18 |
| CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS (K080459) | Chromsystems Instruments & Chemicals GmbH | 2009-11-17 |
| EASYRA MG REAGENT, MODEL 10220 (K092737) | Medica Corp. | 2009-11-17 |
| SINEXUS SINUS STENT GEN 2, MODEL 1999-25 (K092401) | Sinexus, Inc. | 2009-11-17 |
| ELECSYS HCG+B CALCHECK 5 (K092168) | Roche Diagnostics | 2009-11-16 |
| BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY (K091724) | Becton, Dickinson & CO | 2009-11-13 |
| TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET (K093032) | Biosite Incorporated | 2009-11-13 |
| ELECSYS TOXO IGG CALCHECK 5 (K092888) | Roche Diagnostics Corp. | 2009-11-10 |
| OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION (K091914) | Bionostics, Inc. | 2009-11-06 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K093276) | Tangshan Kangyuan Glove Co., Ltd. | 2009-11-04 |
| POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED, BLUE (K092072) | Gx Corporation Sdn Bhd | 2009-11-04 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K093270) | Tangshan Excellence Glove Co., Ltd. | 2009-11-04 |
| MODEL 220 PATIENT MAGNET (K092364) | Cyberonics, Inc. | 2009-11-03 |
| ELECSYS PRECICONTROL THYROAB (K092320) | Roche Diagnostics | 2009-11-03 |
| INTRA LUX HEAD 3 LDSY (K092446) | Kaltenbach & Voigt GmbH & Co. | 2009-11-03 |
| POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K091643) | Gx Corporation Sdn Bhd | 2009-11-02 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K092790) | Zibo Boxiang Plastic & Rubber Co., Ltd. | 2009-11-02 |
| ELECSYS RUBELLA IGGA CALCHECK 5 (K092585) | Roche Diagnostics | 2009-10-30 |