BEUDAMED
    13 results · 19ms · Sources: EU EUDAMED, US FDA

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    COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GLYCOSAL II HBA 1C TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    MODIFICATION TO:EXPEDIUM SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 8, 2025

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 14, 2013

    RADIAL JAW¿ 4

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA·Product code FCL·June 2, 2011

    CAREASSIST

    FDA Adverse Event
    Malfunction ·HILL-ROM - PLUVIGNER·Product code FNL·August 11, 2008

    CONQUEST PRO 12 ST

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·July 16, 2025

    ASTATO XS 9-12

    FDA Adverse Event
    Malfunction ·ASAHI INTECC CO., LTD.·Product code DQX·June 24, 2025

    Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N, 1 cm x 10 cm, product code VG0110N, and 2 cm x 9 cm, product code VG0209N. VASC U-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. Sterilized using aseptic processing techniques. The pericardium is procured from cattle originating in the United States. VASC-Guard is chemically sterilized using ethanol and propylene oxide. UPDATE 9/1/2016 Retrieval of devices only includes Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·August 24, 2016

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·January 1, 2025