BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    SMARTLIPO ND:YAG LASER

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04047872673136·LEVAMED STABILI-TRI ANK SUP BLU L I

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111058523·SPRAGUE RAPPAPORT MGNTA FROST

    POINT 4 FLOWABLE

    FDA 510(k)
    FDA Class 2 ·Dental

    PAIN CARE 2000L

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PRIMEADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 19, 2020

    CONSULT HCG TEST

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code JHI·March 4, 2025

    PRIMEADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 15, 2013

    PRIMEADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 8, 2019

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 16, 2013

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·April 12, 2011

    181 SURGI-MARK W/9 LABELS

    FDA Adverse Event
    Other ·TYCO HEALTHCARE/KENDALL·Product code FZZ·June 17, 2008

    PRIMEADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 17, 2012

    CONSULT HCG URINE CASSETTE 5001 25T

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code JHI·September 9, 2019

    SYRINGE 10ML LL

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·February 25, 2021

    I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404-24, 31404-26, 31404-28, 31404-30, 31404-32, 31404-34, 31404-36, 31404-38, 31404-40, 31404-42, 31404-44, 31404-46, 31404-48, 31404-50, 31404-55, 31404-60, 31404-65, 31404-70, 31404-75, 31404-80, 31457-30, 31457-36, 31457-40, 31457-46, 31457-50, 31457-55, 31457-60, 31652-100, 31652-105, 31652-110, 31652-115, 31652-120, 31652-25, 31652-30, 31652-35, 31652-40, 31652-45, 31652-55, 31652-60, 31652-65, 31652-70, 31652-75, 31652-80, 31652-85, 31652-90, 31652-95, 31731-100, 31731-105, 31731-110, 31731-115, 31731-120, 31731-50, 31731-60, 31731-65, 31731-70, 31731-75, 31731-80, 31731-85, 31731-90, 31731-95, 31732-60, 31734-100, 31734-105, 31734-110, 31734-115, 31734-120, 31734-45, 31734-50, 31734-60, 31734-65, 31734-70, 31734-75, 31734-80, 31734-85, 31734-90, 31734-95. 2. Cortical Screw, Cannulated; Article Numbers: 31357-44, 31357-22, 31357-48, 31277-18, 31357-20, 31357-22, 31357-24, 31357-26, 31357-28, 31357-30, 31357-32, 31357-34, 31357-36, 31357-38, 31357-40, 31357-42, 31357-44, 31357-46, 31357-48, 31357-60, 31357-65, 31357-70. 3. Washer; Article Number: 36851. 4. Washer, Concave; Article Numbers: 36432, 36653, 36732. 5. Washer, Flat; Article Numbers: 36431, 36651, 36653, 36731.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    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