BEUDAMED
    23 results · 20ms · Sources: EU EUDAMED, US FDA

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    ROVERS SPATULA

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

    RMO

    FDA UDI
    Rmo, Inc.·00885797099747·LING RETNR BD 3X3 6 CS WO/INST

    Cortera

    FDA UDI
    Xtant Medical Holdings, Inc.·00840311210961·Reducer Handle, Inline, Radel

    Illico

    FDA UDI
    ALPHATEC SPINE, INC.·00811801038044·Illico Rod Holder

    CRADLE SLING ECONOMY

    FDA UDI
    DARCO INTERNATIONAL, INC.·00609271020719·Pediatric

    NA

    FDA UDI
    aap Implantate AG·04042409048388·K-wire with trocar point, ø2.5, L 200

    HANK'S BALANCED SALTS (HBSS) NO. 200-2520

    FDA 510(k)
    FDA Class 1 ·Hematology

    ALPHA OMEGA DUAL COOLER-HEATER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    C-IT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MALLINCKRODT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code JOH·November 18, 2010

    MALLINCKRODT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTR·December 9, 2010

    MALLINCKRODT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTR·February 1, 2011

    SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·June 9, 2025

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·February 15, 2013

    CVC SET: 16 GA X 12

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code DQY·January 28, 2011

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code KDI·February 26, 2008

    DISP.TROCAR THRD.W.DILATING PIN 12/110MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG·Product code GCJ·July 9, 2019

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; 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

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016