BEUDAMED
    14 results · 27ms · 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.

    MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Spider Limited Wrist Fusion System

    FDA UDI
    Smith & Nephew, Inc.·00885556834800·2.8MM BONE SCREW. 6MM

    Integra® Spider™ Limted Wrist Fusion System

    FDA UDI
    Ascension Orthopedics, Inc.·10381780064800·The Integra Spider Limited Wrist Fusion bone sc...

    Phonak

    FDA UDI
    Phonak AG·07612847978430·Naída S CRT V (black)

    K-DEFIB/PACE, MODEL KDP-60A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    CYNOSURE PHOTOGENICA VL

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

    SPINNING SPIROS® CLOSED MALE LUER, RED CAP

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·November 4, 2025

    SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·March 23, 2016

    ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

    FDA Adverse Event
    Malfunction ·CORDIS CORPORATION·Product code NTE·April 23, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·March 31, 2011

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008

    METRx II Tube, 16mm x 5cm stainless steel tubular retractor, Part No. 9569672

    FDA Recall
    Terminated ·Medtronic Sofamor Danek Instrument Manufacturing·Product code LXH·January 25, 2006

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015