BEUDAMED
    9 results · 19ms · 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 ×

    SHAW II HEMOSTATIC SURGERY SYSTEM

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

    TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 125

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 1, 2012

    IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS

    FDA 510(k)
    FDA Class 2 ·Dental

    SCULPTRA, POLY-L-LACTIC ACID

    FDA Adverse Event
    Injury ·Product code LMH·June 25, 2014

    STOCKERT 70 RF GENERATOR

    FDA Adverse Event
    Malfunction ·STOCKERT GMBH·Product code DRF·January 8, 2013

    XACT CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-VS·Product code NIM·November 11, 2010

    DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    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