BEUDAMED
    22 results · 25ms · 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 ×

    ImagenSPECT 3.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    DJO SURGICAL

    FDA UDI
    Encore Medical, L.P.·00190446929741·SPECIAL, TAPERFILL BIPOLAR TRIALS, +3.5mm OFFSE...

    TEMPFIX EXTERNAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO

    FDA 510(k)
    FDA Class 2 ·Immunology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 29, 2025

    UNKNOWN LIGASURE INSTRUMENT

    FDA Adverse Event
    Injury ·COVIDIEN MFG DC BOULDER·Product code GEI·June 17, 2020

    DESARA

    FDA Adverse Event
    Injury ·CALDERA MEDICAL, INC.·Product code FTL·October 20, 2014

    PROTECTA XT VR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code LWS·August 11, 2011

    SOL SYS 8IN CALC 15.0MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·July 2, 2013

    MICRA

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DYB·June 29, 2021

    XEN 45 GTS

    FDA Adverse Event
    Injury ·ALLERGAN (IRVINE)·Product code KYF·September 5, 2019

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code LMG·May 9, 2023

    HARMONIC ACE 5MM SHEAR

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·January 31, 2020

    UNK LINX MAGNETIC IMPLANT

    FDA Adverse Event
    Injury ·TORAX MEDICAL, INC.·Product code LEI·March 26, 2021

    UNK LINX MAGNETIC IMPLANT

    FDA Adverse Event
    Injury ·TORAX MEDICAL, INC.·Product code LEI·October 7, 2019

    HARMONIC ACE 5MM SHEAR

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 4, 2019

    UNK LINX MAGNETIC IMPLANT

    FDA Adverse Event
    Injury ·TORAX MEDICAL, INC.·Product code LEI·June 21, 2023

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012