BEUDAMED
    19 results · 27ms · 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.

    SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00156031·

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040015643·Sullivan Scissors 5.5"

    Preat

    FDA UDI
    Preat Corporation·00842092169797·Straumann® BL NC-compatible ASC Engaging Ti Bas...

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001563·artVeneer life upper anteriors, CS, BL2

    Scanlan® VASCU-STATT® Plus aprox s-use bulldog clamp w/Gentle-Jaw™ surface

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159000696·Scanlan® VASCU-STATT® Plus aprox s-use bulldog ...

    MODIFICATION TO ENVOY PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TUFF UNICON IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·March 25, 2026

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 13, 2013

    GEMSTAR 7 THERAPY

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC·Product code FRN·January 26, 2011

    LIFESYNC ECG SYSTEM

    FDA Adverse Event
    Death ·LIFESYNC CORPORATION·Product code DRT·February 21, 2008

    UNKNOWN RIGIDFIX CROSS PIN

    FDA Adverse Event
    Injury ·DEPUY MITEK LLC US·Product code HTY·July 29, 2019

    UNK - GUIDES/SLEEVES - RIGIDFIX

    FDA Adverse Event
    Injury ·DEPUY MITEK LLC US·Product code LXH·July 29, 2019

    UNKNOWN BIO-INTRAFIX

    FDA Adverse Event
    Injury ·DEPUY MITEK LLC US·Product code HWC·July 29, 2019

    BACFIX ROD, UNKNOWN

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code HSB·January 16, 2020

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018