BEUDAMED
    10 results · 36ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    SYMBOTEX(TM) COMPOSITE MESH

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MH1 MICROHOLTER RECORDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    1.8MM DRILL BIT/MINI QC/80MM

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HTW·May 29, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·June 16, 2011

    DEXTRUS 4135

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO.·Product code DTB·August 21, 2008

    MEMORY II DOUBLE LUMEN EXTRACTION BASKET

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code LQR·July 28, 2021

    MOZEC¿ RX PTCA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·September 20, 2022

    MOZEC¿ RX PTCA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·September 20, 2022

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015