| MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM (K070239) | Exir Pharmaceutical Co. | 2007-05-25 |
| ACCU-CHEK SMART PIX (K062395) | Roche Diagnostics Corp. | 2007-05-09 |
| TRACKRECORD DATA MANAGEMENT SOFTWARE (K070593) | Home Diagnostics, Inc. | 2007-05-07 |
| EASY CHECK BLOOD GLUCOSE MONITORING SYSTEM (K062538) | Diacare Corp. | 2007-04-30 |
| FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM (K070850) | Abbott Diabetes Care, Inc. | 2007-04-10 |
| ADVOCATE DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223 (K070641) | Taidoc Technology Corporation | 2007-04-09 |
| CLEVER CHEK TD-4230 BLOOD GLUCOSE MONITORING SYSTEM, RD-4230, SURECHEK BLOOD GLUCOSE MONITORING SYSTEM, SMS-4230 (K070472) | Taidoc Technology Corporation | 2007-03-15 |
| RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM (K062567) | Bionime Corporation | 2007-02-16 |
| ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEM (K070088) | Apex BioTechnology Corp. | 2007-02-16 |
| OK METER BLOOD GLUCOSE MONITORING SYSTEM (K063026) | Ok Biotech Co., Ltd. | 2007-02-09 |
| PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS (K070017) | Polymer Technology Systems, Inc. | 2007-01-31 |
| LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 (K063409) | Agamatrix | 2007-01-12 |
| CLEVER CHEK TD-3213/ CLEVER CHEK TD-3215/ DR. T TD-3216/ CLEVER CHEK TD-3217/ CLEVER CHEK TD-3250 BLOOD GLUCOSE PLUS BLO (K062800) | Taidoc Technology Corporation | 2007-01-12 |
| EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G (K062555) | Visgeneer, Inc. | 2006-12-27 |
| FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100 (K063068) | Arkray USA, Inc. | 2006-12-20 |
| COPILOT HEALTH MANAGEMENT SYSTEM (K062770) | Abbott Diabetes Care, Inc. | 2006-12-14 |
| ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM (K062347) | Bayer Healthcare, LLC | 2006-11-22 |
| CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM (K063212) | Taidoc Technology Corporation | 2006-11-22 |
| ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528 (K062434) | Agamatrix | 2006-11-13 |
| GLUCOPLUS BLOOD GLUCOSE MONITORING SYSTEM (K061234) | Glucoplus, Inc. | 2006-10-30 |
| DIACHEX BLOOD GLUCOSE MONITORING SYSTEM (K062829) | Tyson Bioresearch, Inc. | 2006-10-10 |
| EASY CHECK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM; CLEVER CHECK TD-4222, TD-4225, TD-4226 BLOOD GLUCOSE MONITORING SYST (K062235) | Taidoc Technology Corporation | 2006-09-19 |
| ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080 (K062058) | Bayer Healthcare | 2006-09-11 |
| MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM (K062195) | Lifescan, Inc. | 2006-08-16 |
| ACCU-CHEK AVIVA TEST STRIPS (K060620) | Roche Diagnostics Corp. | 2006-08-11 |
| ELEMENT BLOOD GLUCOSE TEST SYSTEM (K060793) | Home Diagnostics, Inc. | 2006-07-25 |
| PRODIGY BLOOD GLUCOSE TEST SYSTEM (K060467) | Diagnostic Devices, Inc. | 2006-07-13 |
| ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4207 (K061181) | Taidoc Technology Corporation | 2006-07-06 |
| PRODIGY (K053593) | Diagnostic Devices, Inc. | 2006-07-06 |
| EZ SMART-168 GLUCOSE MONITORING SYSTEM (K052818) | Tyson Bioresearch, Inc. | 2006-06-16 |
| THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM) (K061328) | E-San Limited | 2006-06-13 |
| GLUCOPACK (K052469) | Healthpia America Corp. | 2006-06-05 |
| ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM (K061118) | Lifescan, Inc. | 2006-05-19 |
| G4, MODEL IGM-0004 (K051651) | U. S. Diagnostics, Inc. | 2006-04-14 |
| ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; ASCENSIA MICROFILL REAGENT STRIP, MODEL 7080 (K060470) | Bayer Healthcare | 2006-04-12 |
| FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001 (K051839) | Abbott Diabetes Care, Inc. | 2006-03-09 |
| EASYMATE BLOOD GLUCOSE MONITORING SYSTEM (K053312) | Bioptik Technology, Inc. | 2006-03-01 |
| MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM (K053635) | Bionime Corporation | 2006-02-21 |
| LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 (K052762) | Agamatrix, Inc. | 2006-01-23 |
| ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM (K053529) | Lifescan, Inc. | 2006-01-17 |
| GLUCOSE PILOT (K052208) | Tianjin New Bay Bioresearch Co., Ltd. | 2005-12-09 |
| SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100 (K052108) | Sein Electronics Co., Ltd. | 2005-12-07 |
| E-SAN BLUETOOTH CRADLE (K052343) | E-San Limited | 2005-12-07 |
| GLUCODR SUPERSENSOR SYSTEM (K050985) | All Medicus Co., Ltd. | 2005-10-07 |
| ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002 (K051514) | Hypoguard USA, Inc. | 2005-10-04 |
| FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM (K051802) | Abbott Diabetes Care, Inc. | 2005-08-09 |
| CLEVER CHECK TD-3215/DR. T TD-3216 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEMS (K051936) | Taidoc Technology Corporation | 2005-08-08 |
| CLEVER CHEK TD-4225, MODEL TD-4225 (K051854) | Taidoc Technology Corporation | 2005-08-05 |
| 3TEST GLUCOSE MONITORING SYSTEM (K050224) | Neuero Engineering, Inc. | 2005-07-13 |
| SIDEKICK BLOOD GLUCOSE TEST SYSTEM (K051147) | Home Diagnostics, Inc. | 2005-07-12 |
| FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM (K050500) | Abbott Diabetes Care, Inc. | 2005-06-27 |
| EZ SMART (K043340) | Vip Diagnostics, LLC | 2005-06-02 |
| PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS (K051213) | Abbott Laboratories, Inc. | 2005-05-27 |
| BLOOD GLUCOSE MONITORING SYSTEM (K043543) | American Healthcare, Inc. | 2005-04-08 |
| CLEVER CHEK TD-3213 (K042795) | Taidoc Technology Corporation | 2005-03-07 |
| RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM (K042678) | Bionime Corporation | 2005-01-03 |
| ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM (K043158) | Bayer Healthcare, LLC | 2004-12-22 |
| ASCENSIA ELITE DIABETES CARE SYSTEM (K043311) | Bayer Healthcare, LLC | 2004-12-22 |
| ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222 (K042005) | Taidoc Technology Corporation | 2004-08-27 |
| EZ SMART (K040848) | Vip International Wholesalers, Corp. | 2004-08-11 |
| PTS PANELS CHOL+GLU TEST PANEL (K041750) | Polymer Technology Systems, Inc. | 2004-07-23 |
| EUSURE BLOOD GLUCOSE MONITORING SYSTEM (K040678) | Eumed Biotechnology Co., Ltd. | 2004-07-14 |
| TAIDOC CHECK (K041107) | Taidoc Technology Corporation | 2004-06-18 |
| PARADIGM LINK BLOOD GLUCOSE METER (K040603) | Becton, Dickinson & CO | 2004-05-19 |
| MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM (K040814) | Abbott Laboratories | 2004-04-15 |
| MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL (K040670) | Home Diagnostics, Inc. | 2004-03-25 |
| PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM (K040628) | Abbott Laboratories | 2004-03-25 |
| TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH) (K032657) | Home Diagnostics, Inc. | 2004-03-24 |
| PRECISION XCEED DIABETES MONITORING SYSTEM (K033845) | Abbott Laboratories | 2004-01-08 |
| FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005 (K031260) | Abbott Diabetes Care, Inc. | 2003-12-19 |
| BTG SMARTEST GLUCOSE TEST SYSTEM (K032029) | Bt Medical | 2003-12-18 |
| GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM (K032985) | Hmd Biomedical, Inc. | 2003-10-21 |
| EASYGLUCO, MODEL IGM0002 (K031501) | American Healthcare, Inc. | 2003-10-16 |
| ACCU-CHEK ADVANTAGE SYSTEM (K032552) | Roche Diagnostics Corp. | 2003-09-12 |
| GLUCOLEADER VALUE (K023279) | Hmd Biomedical, Inc. | 2003-08-04 |
| TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS (K030703) | Home Diagnostics, Inc. | 2003-07-11 |
| MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM (K031843) | Medline Industries, Inc. | 2003-07-03 |
| PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLO (K023256) | Abbott Laboratories | 2003-04-23 |
| ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS (K024194) | Lifescan, Inc. | 2003-02-07 |
| ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL (K024234) | Bayer Corp. | 2003-01-23 |
| SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM (K023832) | Lifescan, Inc. | 2002-12-13 |
| BECTON DICKINSON DIABETES SOFTWARE (K023219) | Becton, Dickinson & CO | 2002-12-06 |
| ASCENSIA DEX 2 DIABETES CARE SYSTEM (K023584) | Bayer Corp. | 2002-11-20 |
| GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020 (K022545) | Hypoguard USA, Inc. | 2002-10-11 |
| BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM (K022581) | Becton, Dickinson & CO | 2002-10-09 |
| SURESTEP BLOOD GLUCOSE MONITORING SYSTEM (K022724) | Lifescan, Inc. | 2002-09-12 |
| MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM EASYBLOOD GLUCOSE MONITORING SYSTEM (K022182) | Abbott Laboratories | 2002-09-09 |
| ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM (K021819) | Lifescan, Inc. | 2002-08-23 |
| ACCU-CHEK COMPACT SYSTEM (K022171) | Roche Diagnostics Corp. | 2002-07-23 |
| MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM (K021827) | Roche Diagnostics Corp. | 2002-07-03 |
| ACCU-CHEK ADVANTAGE MODULE (K021513) | Roche Diagnostics Corp. | 2002-06-11 |
| FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM (K020866) | Abbott Diabetes Care, Inc. | 2002-06-11 |
| MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM (K021448) | Roche Diagnostics Corp. | 2002-06-03 |
| GLUCOMETER DEX BLOOD GLUCOSE SYSTEM (MODIFIED) (K020210) | Bayer Group Diagnostics | 2002-04-30 |
| GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED) (K020208) | Bayer Group Diagnostics | 2002-04-29 |
| SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS (K012975) | Abbott Laboratories | 2002-02-28 |
| LIBERTY BLOOD GLUCOSE MONITORING SYSTEM (K014167) | Polymedica Pharmaceuticals, U.S.A., Inc.] | 2002-02-19 |
| BIOSCANNER PLUS (K014099) | Polymer Technology Systems, Inc. | 2001-12-21 |
| MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM (K012014) | Abbott Diabetes Care, Inc. | 2001-12-05 |
| ACCU-CHEK ACTIVE TEST SYSTEM (K012324) | Roche Diagnostics Corp. | 2001-12-05 |