BEUDAMED
    20 results · 22ms · 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 ×

    Orfit Aerial Couchtop

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777648·LUMBAMED BASIC DORSAL STAYS M SILVER II

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517628169·CoRoent Ant TLIF Ti, 10x10x28mm 12°

    Targeter

    FDA UDI
    Treace Medical Concepts, Inc.·00810111223799·Targeter K-Wire Adapter

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112670·BARRON CORNEAL PUNCH 9.0MM

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780380603·Integra® Jarit® Volkman Retractor, 8-1/2", 4 Pr...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319706022·Ballenger V-Shaped Chisel 6-1/4" (15.6cm), 6mm ...

    SCANLAN®

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159007725·Dennis Multi-Purpose Clamp

    JAS AMYLASE LIQUID REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 10, 2014

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·August 19, 2015

    ACCU-CHEK ® AVIVA COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·October 24, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·July 1, 2013

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·May 2, 2016

    SURSHIELD PUR SAFETY I.V. CATHETER

    FDA Adverse Event
    Injury ·TERUMO CORPORATION - KOFU·Product code FOZ·December 22, 2017

    ANSPACH***REF SP-4604-00***3mm Fluted Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·July 2, 2014

    EMBLEM MRI S-ICD Model A219

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

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014