BEUDAMED
    15 results · 17ms · 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.

    OTOSCOPE

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814688·GENUMEDI SILVER SIZE V

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515227866·Wullstein House Cup Fcps, very del, cvd right

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471121935·K-WIRE - DOUBLE TROCAR 2.0mm DIA x 125mm

    Rampart One Lumbar Interbody Fusion System

    FDA UDI
    SPINEOLOGY INC.·M7404902205·Rampart One Oblique Trial, 10.5mm, M, 8°

    BONE-LOK MVP Cortical-Cancellous Compression Device

    FDA UDI
    INTERVENTIONAL SPINE, INC·81195401195600·3.5mm Diameter x -15-20mm Length

    CARONY

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    PALINDROME P HEMODIALYSIS CATHETER

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

    BD SYRINGE 50ML PERFUSION

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·September 24, 2019

    INTEGRATED APD SET W/CASSETTE3-PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 18, 2010

    AXIUM HELICAL DETACHABLE COIL

    FDA Adverse Event
    Injury ·EV3 NEUROVASCULAR·Product code HCG·January 8, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 24, 2014

    UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. Depression (PMA 970003/S050): VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. Indications outside the U.S.: Epilepsy (Non-US): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizure (with or without secondary generalization) or generalized seizures that are refractory to antiepileptic medications. AspireSR (Seizure Response) features the Automatic Stimulation Mode which is intended for patients who experience seizures that are associated with cardiac rhythm increases known as ictal tachycardia. Depression (Non-US): The VNS Therapy System is indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment-intolerant depressive episode.

    FDA Enforcement
    Class II ·Terminated·Cyberonics, Inc·August 23, 2017

    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