| SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE (K111923) | Pt. Intan Hevea Industry | 2011-11-04 |
| THERMO SCIENTIFIC MAS OMNI-CORE (K110738) | Microgenics Corporation | 2011-11-03 |
| ALCATRON AND / OR MULTIPLE BRAND (K112222) | Alcatron Gloves Factory | 2011-10-27 |
| OSRAM ITOS (K110326) | Osram Sylvania, Inc. | 2011-10-27 |
| POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE (K111772) | Kossan Latex Industries(M)Sdn Bhd | 2011-10-20 |
| DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE,TESTED FOR USE W/ CHEMOTHERAPY DRUGS (K110979) | Advanced Medical Products Sdn Bhd | 2011-10-20 |
| ELECSYS T4 CALCHECK 5 (K112528) | Roche Diagnostics Corporation | 2011-10-18 |
| EZ VEIN INFLATABLE TOURNIQUET (K112874) | Dominion Medical Devices, LLC | 2011-10-17 |
| MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES (K110250) | Total Gloves Sdn Bhd | 2011-10-14 |
| MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4) (K101774) | Alcon Manufacturing, Ltd. | 2011-10-13 |
| RELIEVA SPIN SINUS DILATION SYSTEM (K111875) | Acclarent, Inc. | 2011-10-11 |
| MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE (K111532) | Anthogyr Sas | 2011-10-07 |
| RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL) (K110687) | Acclarent, Inc. | 2011-10-07 |
| SILVER CARE ANITBACTERIAL TOOTHBRUSH (K102871) | Piave Spazzolificio S.P.A. | 2011-10-03 |
| CHIENMAX VIETNAM CO. LTD POWDER FREE BLUE NITRILE EXAMINATION GLOVE (K103675) | Chienmax Vietnam Co., Ltd. | 2011-10-03 |
| RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3 (K110904) | Randox Laboratories, Ltd. | 2011-09-30 |
| RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 (K110846) | Randox Laboratories Limited | 2011-09-30 |
| PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES (K111878) | Cardinal Health, Inc. | 2011-09-29 |
| NEODYNE DRESSING (K112131) | Neodyne Biosciences, Inc. | 2011-09-29 |
| NMR LIPOPROFILE (R) TEST AND NMR PROFILER (K111516) | Liposcience, Inc. | 2011-09-27 |
| LUMAGEM MOLECULAR BREAST IMAGING SYSTEM (K111791) | Gamma Medica-Ideas Incorporated | 2011-09-23 |
| CORELEADER SCAR-DIMMER (K111733) | Coreleader Biotech Co., Ltd. | 2011-09-22 |
| SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE (K111857) | Inmed Gloves Factory | 2011-09-21 |
| CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL (K110061) | Siemens Healthcare Diagnostics | 2011-09-21 |
| STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING (K111868) | Cardinal Health-Medical Products and Services | 2011-09-21 |
| BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE (K112257) | Molnlycke Health Care Us, LLC | 2011-09-20 |
| GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE (K112356) | Bionostics, Inc. | 2011-09-19 |
| PATHASSIST LIGHT FIBER (K111763) | Entellus Medical, Inc. | 2011-09-15 |
| ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2 (K111996) | Elitechgroup | 2011-09-14 |
| ELECSYS MYOGLOBIN CALCHECK 5 (K112113) | Roche Diagnostics | 2011-09-14 |
| POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES (K110945) | Zhaoyang Plastic Co., Ltd. | 2011-09-13 |
| SMARTSHEARS (K112400) | Nuscience Consulting and Management Group, LLC | 2011-09-12 |
| IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS... (K111650) | Immunodiagnostic Systems , Ltd. | 2011-09-06 |
| DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U (K111139) | Ansell Healthcare Products, Inc. | 2011-09-02 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K110944) | Wangda Plastic Co., Ltd. | 2011-09-01 |
| ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS (K103747) | Elitechgroup Seppim S.A.S. | 2011-08-31 |
| VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY (K101234) | Ventana Medical Systems, Inc. | 2011-08-25 |
| ELECSYS N-MID OSTEOCALCIN CALCHECK 5 (K112104) | Roche Diagnostics | 2011-08-25 |
| BIOGEL ORTHOPOR BROWN SURGICAL GLOVE (K112089) | Molnlycke Health Care Us, LLC | 2011-08-24 |
| SHENGKUN CHEMICAL (K110621) | Zibo Shengkun Chemical Industrial Co., Ltd. | 2011-08-24 |
| HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM (K110031) | Instrumentation Laboratory CO | 2011-08-24 |
| POWDER FREE NITRILE PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP A SKIN PROTECTANT DRUG (K111589) | Derma Care Plus Products, LLC | 2011-08-23 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) (K110016) | Rongyao Plastic Produce Co., Ltd. | 2011-08-23 |
| RELIEVA SOLO ELITE SINUS BALLOON CATHETER (K111254) | Acclarent, Inc. | 2011-08-22 |
| POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE (K103734) | Central Medicare Sdn Bhd | 2011-08-19 |
| VITALA CONTINENCE CONTROL DEVICE (K111365) | Convatec, Inc. | 2011-08-19 |
| ELECTROTORQUE TLC (K103027) | Kaltenbach & Voigt GmbH | 2011-08-19 |
| E-CUBE (K111616) | Saeshin Precision Co., Ltd. | 2011-08-19 |
| MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM... (K111807) | Medline Industries, Inc. | 2011-08-18 |
| NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS (K100602) | Nova Biomedical Corp. | 2011-08-17 |
| RAPIDPOINT 405 NEONATAL BILIRUBIN (K110277) | Siemens Healthcare Diagnostics | 2011-08-15 |
| NITRILE POWDER FREE EXAMINATION GLOVES (K110758) | Hartalega Sdn Bhd | 2011-08-12 |
| KIDS ROCK 3 CHAIR (K111739) | Pride Mobility Products Corp. | 2011-08-12 |
| SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE) (K111300) | Pt Mahakarya Inti Buana | 2011-08-12 |
| LATEX EXAMINATION GLOVES POWDER-FREE (BLACK COLOR) WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K111158) | Innovative Gloves Co;, Ltd. | 2011-08-10 |
| SYNTHETIC EXAM GLOVE POWDER FREE COATED WITH ALLOGEL (GREEN/ BLUE / WHITE / MAGENTA / CLEAR - NON COLORED) (K103619) | Shandong Blue Sail Innovation Co., Ltd. | 2011-08-10 |
| SYNTHES RIA SYSTEM (EXPANDED INDICATIONS) (K111437) | Synthes (USA) Products, LLC | 2011-08-10 |
| CYBOW READER, MODELS 300 & 720 (K102188) | DFI Co., Ltd. | 2011-08-09 |
| LO-BAK TRAX (K110858) | Roland F Berthiaume, DC | 2011-08-02 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K111752) | Shandong Jianhong New Material Company | 2011-07-27 |
| ELECSYS T3 CALCHECK 5 (K111552) | Roche Diagnostics | 2011-07-21 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K110970) | Ppp Medical and Safety Products Company Limited | 2011-07-21 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR (NON-COLORED) (K110966) | Ppp Medical and Safety Products Company Limited | 2011-07-21 |
| POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVE (K111598) | Lpl (Hui Zhou) Glove Co., Ltd. | 2011-07-20 |
| POWDER FREE NITRILE EXAMINATION GLOVES (K111328) | Gx Corporation Sdn Bhd | 2011-07-15 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR (K110857) | Shandong Zhanpeng Medical Products Co., Ltd. | 2011-07-15 |
| CENTRO FAMILY OF MANUAL WHEELCHAIRS (K111045) | Otto Bock Healthcare LP | 2011-07-15 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, BLUE COLOR (K111240) | Xuzhou Full Sun Medical Products , Ltd. | 2011-07-14 |
| ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE (K110960) | Koon Seng Sdn Bhd | 2011-07-14 |
| POWDER FREE NITRILE EXAMINATION GLOVES (K110418) | W.A. Rubbermate Co., Ltd. | 2011-07-13 |
| EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT (K111036) | Medica Corporation | 2011-07-12 |
| ELECSYS PRECICONTROL VARIA 3 (K111506) | Roche Diagnostics | 2011-07-08 |
| ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA (K103714) | Ansell Healthcare Products, LLC | 2011-07-07 |
| SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (BLUE/GREEN) (AND MULTIPLE LABELS) (K111012) | True Glove Factory | 2011-07-06 |
| VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT (K110880) | Maine Standards Company, LLC | 2011-07-05 |
| SENSICARE POWDER-FREE POLYMER COATED POLYSOPRENE SURGICAL GLOVES, STERILE (K102177) | Medline Industries, Inc. | 2011-06-30 |
| ASICO SOFTIP INJECTOR SYSTEM (K103495) | Asico, LLC | 2011-06-29 |
| THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO (K110616) | Microgenics Corp. | 2011-06-29 |
| VITAL SERUM CONTROLS (K111063) | Vital Diagnostics (Manufacturing) Ptyltd | 2011-06-28 |
| INDIKO (K110035) | Thermofisher Scientific OY | 2011-06-28 |
| NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM (50 MG OR LESS) (K111133) | Ssc Surat Thani | 2011-06-24 |
| DISPOSABLE THYROID COLLAR (K110900) | Bloxr Corporation | 2011-06-24 |
| SAFETYMATE TALKING FIRST AID (K110625) | Safetymate, Inc. | 2011-06-17 |
| SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS) (K111297) | Premier Medical Gloves Factory | 2011-06-16 |
| AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301 (K101641) | Ag Digital Technology Corp. | 2011-06-16 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR (K111459) | Jiangsu Alfa Glove Co., Ltd. | 2011-06-16 |
| ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT (K102274) | Arvik Enterprises/ Mini Lap Technologies | 2011-06-15 |
| POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES (K110297) | Comfort Rubber Gloves Industries Sdn. Bhd. | 2011-06-15 |
| ENTELLUS MEDICAL SINUS GUIDEWIRE (K110739) | Entellus Medical, Inc. | 2011-06-14 |
| AEU-26L ELCTRONIC ENDODONTIC SYSTEM (K111078) | Aseptico, Inc. | 2011-06-14 |
| POWDER FREE NUTRILE PATIENT EXAMINATION GLOVES, BLUE COLOR (K110247) | Jiangsu Dongling Plastic & Rubber Co., Ltd. | 2011-06-10 |
| POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WHITE COLOR (K110248) | Jiangsu Dongling Plastic & Rubber Co., Ltd. | 2011-06-10 |
| TEMPOCEM (K110759) | Dmg USA, Inc. | 2011-06-10 |
| AUTODELFIA NEONATAL IRT KIT (K110274) | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 2011-06-10 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K110969) | Ppp Medical and Safety Products Company Limited | 2011-06-10 |
| AUDIT MICROCV IMMUNOASSAY LINEARITY SET (K103601) | Aalto Scientific, Ltd. | 2011-06-10 |
| ELECSYS SHBG CALCHECK 5 (K111349) | Roche Diagnostics | 2011-06-09 |
| STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG (K110272) | Cardinal Health, Inc. | 2011-06-08 |
| ILLUMINATING SINUS SEEKER (K110158) | Entellus Medical, Inc. | 2011-06-07 |
| MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM (K110753) | Dentsply International, Inc. | 2011-06-06 |