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Conmed Corporation devices, product family

by Conmed Corporation 67 variants Basic UDI-DI 084585408541DB

Shared by every variant

Manufacturer
Conmed Corporation(67)
Basic UDI-DI
084585408541DB
Risk class
Class IClass IIIClass IIClass IIa (varies)
Legislation
MDRMDD (varies)
Market status
67 on the market
Official record
EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 084585408541DB.

Recalls

5 recalls · FDA

  • Z-0454-2015 Class I · terminated · 6 Nov 2014
    Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death or serious injury.
  • Z-0455-2015 Class I · terminated · 6 Nov 2014
    Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death or serious injury.
  • Z-0459-2015 Class I · terminated · 6 Nov 2014
    Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death or serious injury.
  • Z-0456-2015 Class I · terminated · 6 Nov 2014
    Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death or serious injury.
  • Z-1317-2013 Class II · terminated · 3 May 2013
    ConMed was notified by the contract manufacturer that their wire/connector supplier reported damage to the connector tooling which could pinch or compress the lead wire filaments and potentially render the device incapable of delivering the appropriate energy or shock to the patient and/or could cause potential injury to user or patient.

Recalls matched to the 50 devices listed on this page; other pages of the family can carry others.

Variants

67 devices · page 1 of 2

Variants of Conmed Corporation devices, Basic UDI-DI 084585408541DB
UDI-DISize and differences
CLEARTRACE 1700-00310653405004233 —On the market
CLEARTRACE 1700-00510653405004240 —On the market
CLEARTRACE 1700-03010653405004264 —On the market
CLEARTRACE 1700-05010653405055617 —On the market
CLEARTRACE 1700C-00510653405059158 —On the market
CLEARTRACE 1700C-05010653405059165 —On the market
CLEARTRACE 2700-00110653405005339 —On the market
CLEARTRACE 2700-00310653405005346 —On the market
CLEARTRACE 2700-00510653405005353 —On the market
CLEARTRACE 2700-03030653405005364 —On the market
CLEARTRODE 1720-00310653405004295 —On the market
CONMED 38-404-110653405005957 —On the market
CONMED 38-402-1 38-402-1 / 38-402-110653405005933 —On the market
DYNA/TRACE 1500-00310653405003618 —On the market
DYNA/TRACE 1500-00410653405003625 —On the market
DYNA/TRACE 1500-03010653405003649 —On the market
DYNA/TRACE 1550-00510653405003724 —On the market
DYNA/TRACE 1555-00510653405003731 —On the market
EXACTRACE 1510-00110653405003663 —On the market
EXACTRACE 1510-03010653405003694 —On the market
FASTRACE 1915-10010653405004585 —On the market
HEARTBEAT 1925-10010653405033714 —On the market
HUGGABLES 1620-00310653405004011 —On the market
INSTATRACE 1590-00310653405003762 —On the market
INVISATRACE 1680-00110653405004127 —On the market
INVISATRACE 1680-00310653405004134 —On the market
INVISATRACE 1680-00510653405004141 —On the market
INVISATRACE 1680-03010653405004158 —On the market
NEOTRODE 1731-00330653405004329 —On the market
NEOTRODE 1731C-00330653405064071 —On the market
NEOTRODE 1741C-00330653405064095 —On the market
PadPro 2516Z10653405042525 —On the market
PadPro 2001-C 2001-C / 2001-C10653405040002 —On the market
PadPro 2001-EPS 2001-EPS / 2001-EPS10653405040033 —On the market
PadPro 2603 2603 / 260310653405040118 —On the market
PadPro 2603Z 2603Z / 2603Z10653405042556 —On the market
POSITRACE 1870-00510653405004516 —On the market
POSITRACE 1870-03010653405004523 —On the market
POSITRACE 1870-05010653405081937 —On the market
POSITRACE 1870C-00310653405059202 —On the market
POSITRACE 1870C-00510653405059226 —On the market
POSITRACE 1870C-05010653405059233 —On the market
SOFTRACE 2320-00310653405039006 —On the market
SOFTRACE 2321C-00330653405064125 —On the market
SURETRACE 1800-00110653405004387 —On the market
SURETRACE 1800-00310653405004394 —On the market
SURETRACE 1800-03010653405004417 —On the market
SURETRACE 1800C-00310653405059172 —On the market
SURETRACE 1800C-00510653405059189 —On the market
SURETRACE 1800C-05010653405059196 —On the market