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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    SENTRYSUITE PRODUCT LINE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MicroSelectron Digital

    FDA UDI
    Nucletron B.V.·08717213015364·microSelectron Transfer Tube for 5F Flexibles (2)

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1100530·Caddie, 7.5mm Screws

    OLYMPUS CF TYPE Y0023-L, Y0023I

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

    OPTIMA

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BIPAP A30-S SILVER

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·September 25, 2024

    BIPAP A30, SILVER

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·September 25, 2024

    BIPAP A30

    FDA Adverse Event
    Death ·RESPIRONICS, INC.·Product code MNS·September 13, 2023

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·July 31, 2020

    ALENTI

    FDA Adverse Event
    Malfunction ·ARJO HOSPITAL EQUIPMENT AB·Product code ILS·April 19, 2013

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code FNL·September 23, 2014

    MODEL B 110 V ELECTRO DERMATOME COMPLETE KIT

    FDA Adverse Event
    Other ·INTEGRA, CINCINNATI·Product code GFD·May 17, 2011

    BIPAP A30-S SILVER

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·September 25, 2024

    The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·June 12, 2013

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    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

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025