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

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    PRO-FEMUR R

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00530161·

    CUSTOMED

    FDA UDI
    CUSTOMED INC·M20890030160·ENDOTRACHEAL TUBE, CUFFED, SIZE: 10.0MM

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193105543·HA PEEK EVOS Straight, ,16mmx9mmx 22mm , FLAT ...

    Medical Facets NC

    FDA UDI
    MEDICAL FACETS NC LLC·M933MDF20030160·1.5mm Cortex Screw, 1.5 Hex, Self-Tapping, 16mm

    BARCOMED 5MP2

    FDA 510(k)
    FDA Class 2 ·Radiology

    MERETEK UBT_LITE BREATH TEST FOR H. PYLORI

    FDA 510(k)
    FDA Class 1 ·Microbiology

    0009613348-2025-003016

    FDA Adverse Event
    Injury ·INSTITUT STRAUMANN AG·Product code DZE·March 10, 2025

    SPINAL NEEDLE 22GA 3.00 IN

    FDA Adverse Event
    Malfunction ·Product code BSP·June 17, 2021

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 13, 2013

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·February 8, 2011

    GORE DUALMESH BIOMATERIAL WITH CORDUROY TIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code FTL·February 25, 2008

    OMNIPOD 5 CONTROLLER

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code QFG·April 7, 2026

    OMNIPOD 5 POD

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code QFG·April 7, 2026

    Guardian Services, Guardian Software, Part Number 0240-009-430 (Guardian Services) with Part Numbers 0250-003-016, 0250-003-017 and 0250-003-018 (OrthoPad) Intended use of Guardian Services is to act as a medical data backup and disaster recovery plan.

    FDA Recall
    Terminated ·Stryker Imaging·Product code LMB·August 3, 2009

    AUTOCOMP6 XPS High Speed Compounder REF 58810

    FDA Enforcement
    Class II ·Terminated·The Metrix Company·August 3, 2016

    Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    Alcon Custom Ophthalmic Surgical Procedure Packs

    FDA Enforcement
    Class II ·Terminated·Alcon Research, LLC·April 7, 2021

    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

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024