BEUDAMED
    21 results · 24ms · Sources: EU EUDAMED, US FDA

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    BIOMET EXTERNAL WRIST PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Premier Cavity Prep

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00348783008326·CPI Carver-Black DE_BC 89/92

    Alpha-Tec Systems

    FDA UDI
    Alpha-TEC Systems, Inc.·00816085020518·AFB Stain Control Slides

    CAMLOG® Screw-Line-compatible

    FDA UDI
    Preat Corporation·00842092125151·CAMLOG® Screw-Line-compatible 3.3mm Blue Light ...

    SCANLAN® Needle Holders

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159019193·Jacobson Micro Needle Holder Flat Handle

    FacetFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361020042·Facet Screw Assy, SOTW, 5.5 x 40mm

    VIDAS® LYME IGG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code LSR·August 21, 2019

    VIDAS® LYME IGG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code LSR·October 10, 2019

    AMERLITE TT3 ASSAY, LAN.0003/2003 240/144 KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DELTA-TT ACETAB.CUP 52 MM

    FDA Adverse Event
    Injury ·LIMACORPORATE SPA·Product code LPH·September 25, 2020

    SERAGARD INJECTION PATCH

    FDA 510(k)
    FDA Class 1 ·General Hospital

    RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    DELTA-TT ACETAB.CUP 52 MM

    FDA Adverse Event
    Malfunction ·LIMACORPORATE S.P.A.·Product code LPH·September 25, 2020

    OT ULTRALINK METER

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

    SYNCHROMED II INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code LKK·February 20, 2011

    HORNET INSERTER, BIOSTINGER IMPLANT 10MM

    FDA Adverse Event
    Malfunction ·CONMED LINVATEC·Product code HWC·February 21, 2008

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·August 11, 2021

    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

    Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.

    FDA Enforcement
    Class I ·Terminated·Abbott·May 23, 2018