Disetronic Medical Systems

FDA Regulatory Profile

Disetronic Medical Systems appears in FDA public data with 0 recalls, 29 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on May 14, 2010.

Summary

Total Recalls
0
510(k) Clearances
29
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K100704ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICEMay 14, 2010
K070189ACCU-CHEK ULTRAFLEX INFUSION SETFeb 21, 2007
K063146ACCU-CHEK LINKASSISTNov 27, 2006
K060876ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP Jun 15, 2006
K042887ACCU-CHEK SPIRITMar 18, 2005
K043000MODIFICATION TO D-TRONPLUSDec 1, 2004
K033892ULTRAFLEX INFUSION SETMar 9, 2004
K023471DISETRONIC H-TRONPLUS INSULIN INFUSION PUMPOct 29, 2002
K022831MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMPSep 11, 2002
K021725DISETRONIC D-TRON INSULIN INFUSION PUMPAug 2, 2002
K013782DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLENov 20, 2001
K003977DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SETFeb 15, 2001
K001629DISETRONIC MULTIFUSE INFUSION PUMP SYSTEMJun 21, 2000
K994186DISETRONIC D-TRON INSULIN INFUSION PUMPDec 30, 1999
K994197DISENTRONIC PENFINE INJECTION PEN NEEDLEDec 29, 1999
K993666DISETRONIC PEN P100Nov 22, 1999
K991376DAHEDI INSULIN INFUSION PUMPJun 15, 1999
K990259DISETRONIC MULTIFUSE INFUSION PUMP SYSTEMFeb 12, 1999
K982966DISETRONIC PENOct 19, 1998
K982399DISETRONIC PENFINE INJECTION PEN NEEDLEAug 6, 1998