BEUDAMED
    7 results · 11ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Status: Terminated × Clear all

    Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150, MOL1451, MOL1452, MOL1455

    FDA Enforcement
    Class I ·Terminated·Focus Diagnostics Inc·April 13, 2016

    Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2650, MOL1451, MOL1452, MOL1455

    FDA Enforcement
    Class II ·Terminated·Focus Diagnostics Inc·April 13, 2016

    Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2850, MOL1451, MOL1452, MOL1455

    FDA Enforcement
    Class I ·Terminated·Focus Diagnostics Inc·April 13, 2016

    Canister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revision .0C Coolant canister for use with surgical laser.

    FDA Enforcement
    Class II ·Terminated·Candela Corporation·October 30, 2019

    Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant canister for use with surgical laser.

    FDA Enforcement
    Class II ·Terminated·Candela Corporation·October 30, 2019

    Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C Coolant canister for use with surgical laser.

    FDA Enforcement
    Class II ·Terminated·Candela Corporation·October 30, 2019

    Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for use with surgical laser.

    FDA Enforcement
    Class II ·Terminated·Candela Corporation·October 30, 2019