BEUDAMED
    19 results · 25ms · Sources: EU EUDAMED, US FDA

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    SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACE

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950029549·SCISSOR KELLY ANGLED SMOOTH 6-1/4" 16CM

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092002007·artVeneer life lower posteriors, S, A1

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193105345·HA PEEK EVOS Straight, ,7mmx8mmx 30mm , FLAT 0...

    KineMatch® PFR System

    FDA UDI
    Kinamed, Inc.·00818720010922·TROCHLEA FIXATION NAIL PILOT DRILL

    Battalion

    FDA UDI
    ALPHATEC SPINE, INC.·00840967188492·Battalion, LLIF Trial, 0°, 20 mm Wide, 07 mm X ...

    *

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GAG·May 21, 2002

    POROCOAT PRODIGY HIP PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET)

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·April 1, 2024

    CARDIOSAVE HYBRID, TYPE B PLUG

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·May 15, 2025

    CEMENT, BONE, VERTEBROPLASTY

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code NDN·March 13, 2013

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM DE MEXICO S DE RL DE CV·Product code FPO·July 3, 2014

    ENDO GIA UNIVERSAL XL

    FDA Adverse Event
    Injury ·NORTH HAVEN - USS·Product code GAG·February 22, 2008

    CSI Toric, soft (hydrophilic) contact lenses

    FDA Recall
    Terminated ·Ciba Vision Corporation·Product code LPL·September 13, 2006

    bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    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

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022