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

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    LOW ADHERENT AFM AG DRESSINGS

    FDA 510(k)
    FDA Unclassified ·Unknown

    FlexStep

    FDA UDI
    Liftup A/S·05714420031418·FlexStep V2, 900, 4 step, indoor

    NexxZr™ / W-98-26-UT-C400-ML

    FDA UDI
    SAGEMAX BIOCERAMICS, INC·00842271139597·

    PMT CORPORATION - STEREOTACTIC

    FDA UDI
    PMT CORPORATION·10650551098277·THUMB SCREW FOR RULER

    SLIP JOINT PLIERS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896051690·SLIP JOINT PLIERS STAINLESS STEEL

    MICROGYN PLUS STIMULATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    UBM PLUS, MODEL P45

    FDA 510(k)
    FDA Class 2 ·Radiology

    GALAXY G3 MINI 1MM X 2CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·December 5, 2020

    PERCLOSE¿ PROSTYLE¿

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR INC.·Product code MGB·June 10, 2025

    EXPRESS¿ LD VASCULAR

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIO·May 9, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 19, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 25, 2011

    Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-05, 19265-05, 13894-16, 17550-08, 12236-18, 11854-15, 8043-29, 12466-17, 15599-17, 14764-09, 13194-16, 17069-09

    FDA Recall
    Open, Classified ·Alcon Research LLC·Product code LRO·February 10, 2025

    StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.

    FDA Enforcement
    Class II ·Terminated·Abbott Vascular·February 22, 2017

    Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-05, 19265-05, 13894-16, 17550-08, 12236-18, 11854-15, 8043-29, 12466-17, 15599-17, 14764-09, 13194-16, 17069-09

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·March 12, 2025

    Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·November 6, 2024

    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

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

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

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

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