BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    PINPOINT GT SAFETY INTRODUCER NEEDLE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16741424450·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1674142445060·

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X1424450·14mm H x 24mm W x 45mm L x 0 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587L142445120·14mm H x 24mm W x 45mm L XLIF Trial 12 degree L...

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X14244580·14mm H x 24mm W x 45mm L x 8 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X142445120·14mm H x 24mm W x 45mm L x 12 degrees XLIF

    PRECISION MONTAGE MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 23, 2021

    ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 5, 2025

    BD¿ INTIMA-II CATHETER

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·April 3, 2019

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 3, 2013

    SEMI-ELECTRIC BED

    FDA Adverse Event
    Death ·MEDLINE INDUSTRIES, INC.·Product code FNL·June 22, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 3, 2008

    da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015

    da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS45; c) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS50; d) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS55; e) PEDIATRIC TRACHEOSTOMY TUBE 6.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS60

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015