BEUDAMED
    18 results · 30ms · Sources: EU EUDAMED, US FDA

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    Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ePatch Sensor 2.5, Rebuilt

    FDA UDI
    BRAEMAR MANUFACTURING, LLC·B146EP25R0·

    24M - Salt River Project-21 - Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588022017·24M - Salt River Project-21 - Metal

    Vilex Power Accessory

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731122308·KWire .078 x 9"(2.0x225mm))

    ClampEase U-View Disc

    FDA UDI
    Semler Technologies, Inc.·10815614020316·The ClampEase U-View U-LRS100 Disc is a femoral...

    DASH KNEE

    FDA 510(k)
    FDA Class 2 ·Neurology

    PALABOND

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    SCULPTRA

    FDA Adverse Event
    Injury ·Q-MED AB·Product code LMH·December 16, 2025

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·October 15, 2014

    ENRHYTHM DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 28, 2013

    BD DISCARDIT¿ II SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·June 15, 2022

    LAUNCHER UNK GUIDE CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC, INC·Product code DQY·January 13, 2025

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code NEW·November 5, 2024

    ATTUNE

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JWH·March 16, 2026

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021