BEUDAMED
    14 results · 21ms · 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 ×

    3M LITTMANN TELESTETH ONLINE AUSCULATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613154274451·BONE SCREW,CROSS-PIN,MP,SELF-TAPPING

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450169056·

    DRACO

    FDA UDI
    HNM TOTAL RECON LLC·00841742122014·DRACO MetaFuse OpenWedge Plate, Ti - #4, L

    ROCHE ONLINE GENTAMICIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HANDLE CEV669B DIA 5MM ANG BIPOLAR [MXI/XOM]

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INSTRUMENTATION S.A.S·Product code GEI·August 20, 2013

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 20, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 10, 2011

    GLENOID DIA 36

    FDA Adverse Event
    Injury ·DEPUY FRANCE S.A.·Product code KWS·August 14, 2008

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·April 16, 2013

    Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 22 mm - usable length 88mm - delivery system 16 FR; Catalog no. TFLE-22-88.

    FDA Recall
    Terminated ·Cook, Inc.·Product code MIH·June 10, 2004

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022