BEUDAMED
    18 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 ×

    VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Fixion Nailing System

    FDA UDI
    CARBOFIX ORTHOPEDICS LTD·07290109330174·The nail is intended for use in the fixation of...

    Fixion Nailing System

    FDA UDI
    CARBOFIX ORTHOPEDICS LTD·07290109330860·An interlocking intramedullary nail intended fo...

    Oticon

    FDA UDI
    Oticon A/S·05707131234803·K50, ITC P L BE KIT

    N/A

    FDA UDI
    HANS RUDOLPH, INC.·00874750003242·75 V2 PETITE 22ID STRGT W/HG

    Segmental Plating System

    FDA UDI
    ALPHATEC SPINE, INC.·00190376545493·SPS VA Self-Tap Screw, 3.5 x 24 mm

    Proximity

    FDA UDI
    ALPHATEC SPINE, INC.·00190376694566·PROXIMITY VA SELF-TAP SCREW, 3.5 x 24mm

    VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TROCHANTERIC DYAX NAIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HAHN TAPERED IMPLANT Ø3.5 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·October 11, 2023

    HAHN TAPERED IMPLANT Ø3.5 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 20, 2025

    ASR ACETABULAR IMPLANT 60

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 15, 2013

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·February 28, 2014

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code INK·May 24, 2011

    4.5 BROAD SCP PLT 26-H STER

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;

    FDA Enforcement
    Class II ·Ongoing·Ventec Life Systems, Inc.·June 30, 2021

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

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