BEUDAMED
    21 results · 28ms · 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.

    ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR

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

    ConMed

    FDA UDI
    Provision·B504OM50715530·

    NON-BR2000 LARGE BONE BLADES

    FDA UDI
    Peter Brasseler Holdings, LLC·00887919095385·KM71-553

    Reprocessed Oscillating Saw Blade,19.5 x 71 x 1.2mm

    FDA UDI
    SURETEK MEDICAL·B39050715531·

    N/A

    FDA UDI
    STRYKER SUSTAINABILITY SOLUTIONS, INC.·00885825012083·Oscillating Saw Blade

    CONMED

    FDA UDI
    Conmed Corporation·10845854005644·OSCILLATOR BLADE, 19.5 X 63 X 0.6 MM (.024")

    NA

    FDA UDI
    STERILMED, INC.·10888551020886·SAW BLADE OSCILLATING LARGE BONE

    SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BREAS PV 100 CPAP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 26, 2025

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 18, 2022

    ARCHITECT HAVAB-G

    FDA Adverse Event
    Malfunction ·ABBOTT GERMANY·Product code LOL·April 22, 2013

    *

    FDA Adverse Event
    Injury ·I-FLOW CORP·Product code MEB·July 9, 2008

    UNKNOWN DEPUY PFC SZ 3 CR INSERT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·April 15, 2011

    BIOLOX HEAD HIP IMPLANT

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code JDI·April 25, 2019

    UNKNOWN BIOLOX HEAD

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·February 13, 2018

    CERASUL, HEAD, M/0, TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code JDI·November 4, 2019

    SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical drill bits, blades, burs, chisels, rasps, taps and reamers are specially designed surgical accessories to help the surgeon cut and drill bone and bony structures. Reprocessed surgical accessories are indicated for use in patients requiring surgery involving bone and bony structures.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 18, 2015

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022