BEUDAMED
    14 results · 37ms · 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.

    COMPLETE BRAND MULTI-PURPOSE SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114247·VECTIS 2-HOLE 4MM 25GA (PK/10)

    POSSIS MYOCARDIAL SUTURELESS LEAD

    FDA Adverse Event
    Injury ·POSSIS MEDICAL, INC.·Product code LWS·November 14, 1998

    MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    INSIGHT 4000 ENDOSCOPE

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

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·November 29, 2024

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

    TOTALCARE BARIATRIC

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC·Product code FNL·February 22, 2011

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·February 21, 2008

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 7, 2022

    LACTOSORB 14 MM RAPIDFLAP CLAMP

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code JEY·July 6, 2016

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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