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 ×

    AMSCO V-PRO 1 LOW/PLUS/MAX TEMPERATURE STERILIZATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Remote Alarm

    FDA UDI
    Respironics, Inc.·00606959023642·Remote Alarm International

    M-Flex®

    FDA UDI
    DIVERSATEK HEALTHCARE, INC.·00816734020067·Blue Silicone Tungsten Maloney Esophageal Dilat...

    PMT® CORPORATION HALO

    FDA UDI
    PMT CORPORATION·10650551093067·EXTENDED RANGE (X-LONG) HEADBLOCKS, FOR USE WIT...

    ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ENGUARD REMOTE PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·May 23, 2008

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·April 26, 2022

    EXPRESS? VASCULAR SD

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code FGE·May 20, 2013

    AIRLIFE

    FDA Adverse Event
    CAREFUSION 211, INC..·Product code BZD·September 4, 2014

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 10, 2011

    WAVEWRITER ALPHA? PRIME 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 10, 2026

    MATRIXMIDFACE SCREWDRIVER BLD MQC/SELF-RETAINING/76MM

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code HXX·May 1, 2015

    MATRIXMIDFACE SCREWDRIVER BLD MQC/SELF-RETAINING/76MM

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code HXX·May 1, 2015

    MATRIXMIDFACE SCREWDRIVER BLD MQC/SELF-RETAINING/76MM

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code HXX·May 1, 2015

    MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·December 26, 2012

    MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.

    FDA Recall
    Terminated ·Integra LifeSciences Corporation·Product code HBL·November 5, 2012

    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

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·January 1, 2025