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

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    GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    36M - Navajo Tribal Utility Authority

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588012797·36M - Navajo Tribal Utility Authority

    CONDYLAR MEDIAL RETRCT LRG

    FDA UDI
    W.H. Holden, Inc.·D9282011790·

    CONDYLAR MEDIAL RETRCT SML

    FDA UDI
    W.H. Holden, Inc.·D92820117910·

    SUPER NOVA, ACUBEAM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A

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

    ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025

    WALLFLEX DUODENAL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MUM·January 22, 2025

    ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·March 10, 2011

    TOTAL ASR ACET IMP SIZE 50

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·October 27, 2014

    EONMINI IPG 16 CHANNEL IPG

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 29, 2011

    SPECTRA OPTIA

    FDA Adverse Event
    TERUMO BCT·Product code LKN·July 2, 2013

    WALLFLEX COLONIC

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MQR·December 18, 2024

    WALLFLEX COLONIC

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MQR·December 31, 2024

    SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL1¿, 81 CM LENGTH, 8.5F

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL·Product code DYB·August 28, 2019

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 7, 2016

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024