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

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    Filters Regulation: Us FDA ×

    SYNGO, CT DUAL ENERGY

    FDA 510(k)
    FDA Class 2 ·Radiology

    COLLAGEN POWDER

    FDA 510(k)
    FDA Unclassified ·Unknown

    PERFORMANCE WATER TREATMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·December 21, 2011

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 1, 2014

    ACCU-CHEK ® INFORM METER

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·May 29, 2013

    ANGIOSCULPT PTCA SCORING BALLOON CATHETER (EX)

    FDA Adverse Event
    Injury ·ANGIOSCORE, INC.·Product code NWX·June 8, 2011

    TPRLC XR MP T1 PPS

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code JDI·February 4, 2021

    TAPERLOC XR MP T1 PPS

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWZ·May 7, 2020

    TAPERLOC 133 MP SP T1 PPSHO

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWZ·May 7, 2020

    TAPERLOC 133 MP TYPE1 PPS HO 1

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWZ·May 7, 2020

    TAPERLOC XR MP T1 PPS

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWZ·May 7, 2020

    TAPERLOC 133 MP T1 PPS SO

    FDA Adverse Event
    Malfunction ·.·Product code KWZ·May 7, 2020

    TPRLC 133 FP TYPE1 PPS

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code JDI·February 4, 2021

    TPRLC XR MP T1 PPS

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code JDI·February 4, 2021

    TPRLC XR T1 PPS

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code JDI·February 4, 2021

    TPRLC 133 MP TYPE1 PPS HO

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWL·February 4, 2021

    TPRLC 133 MP TYPE1 PPS

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWL·February 4, 2021

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015