BEUDAMED
    6 results · 16ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class I × Clear all

    Part 510180 Disposable Single Infusion Pump, ... Elastomeric Pump 300 mL, 2mL/hr,... found in : GoPump Kit 510201-BP, 5 fenestrated catheter & BIOPATCH; Go Pump Kit 510349-BP, Epidural Catheter, BioPatch; Go Pump Kit 510642 Disposable Single Infusion Pump, Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication. The medication is delivered via tubing to the surgical site at a very slow rate

    FDA Enforcement
    Class I ·Terminated·Symbios Medical Products, LLC·June 12, 2013

    Part 510121 Disposable Infusion Pump, ...Elastomeric Pump 300 mL, 4mL/hr,...sterile.. found in the following kits GoPump Kit 510203-BP, Epidural catheter & BIOPATCH GoPump Kit 510204, 2.5" Fenestrated catheter GoPump Kit 510204 BP, 2.5 Fenestrated catheter & Biopatch GoPump Kit 510205BP, 5" Fenestrated catheter & Biopatch GoPump Kit 510551-BP, 2.5 Fenestrated catheter & Biopatch GoBlock kit 510608 Disposable Single Infusion Pump; Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication.

    FDA Enforcement
    Class I ·Terminated·Symbios Medical Products, LLC·June 12, 2013

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021