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 ×

    LD-I 75 AND LD-I 200

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AGILTRAC .035 PERIPHERAL DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code LIT·July 29, 2008

    UNKNOWN

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·April 23, 2013

    MX-PRO R-3 AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·April 19, 2011

    TRANSVENE

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code LWS·July 10, 2008

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024