BEUDAMED
    12 results · 26ms · Sources: EU EUDAMED, US FDA

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    OPRATEX ABDOMINAL PAD

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Preat

    FDA UDI
    Preat Corporation·00842092138786·Sphero Block Abutment Astra EV 4.2 x 4mm (1.8mm...

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    FDA Adverse Event
    Other ·HAMILTON BONADUZ AG·Product code JTC·July 13, 1998

    DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000

    FDA 510(k)
    FDA Class 2 ·Radiology

    CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS

    FDA 510(k)
    FDA Class 2 ·Dental

    SYMBIQ DUAL CHANNEL

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD·Product code FRN·February 21, 2014

    SURGICAL MESH

    FDA Adverse Event
    Injury ·Product code FTL·October 23, 2012

    TITAN XL

    FDA Adverse Event
    Injury ·CUTERA·Product code GEX·August 10, 2010

    Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

    FDA Enforcement
    Class I ·Ongoing·Zyno Medical LLC·June 18, 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

    Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·January 13, 2021

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018