BEUDAMED
    66 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    AIR MASSAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Archon

    FDA UDI
    Nuvasive, Inc.·00887517499424·Archon Screw, Ø4.0x10mm SD Fixed

    TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Reprocessed DecaNav Diagnostic Electrophysiology Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GRANUFLO

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 21, 2014

    NEXGEN CR-FLEX FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code JWH·October 5, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 19, 2015

    ACL TOP 500 CTS, automated coagulation laboratory instrument.

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code GKP·June 3, 2014

    ACL TOP CTS, automated coagulation laboratory instrument.

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code GKP·June 3, 2014

    HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy.

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code GJS·April 9, 2013

    ACL TOP 300 CTS, automated coagulation laboratory instrument.

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code GKP·June 3, 2014

    ACL TOP (Base), automated coagulation laboratory instrument.

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code GKP·June 3, 2014

    ACL TOP 700 CTS, automated coagulation laboratory instrument.

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code GKP·June 3, 2014

    ACL TOP 700, automated coagulation laboratory instrument.

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code GKP·June 3, 2014

    ACL TOP 700 LAS, automated coagulation laboratory instrument.

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code GKP·June 3, 2014

    AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.

    FDA Recall
    Completed ·Accriva Diagnostics, Inc.·Product code DQA·September 27, 2024

    HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code GGN·November 15, 2013

    HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code GGN·November 15, 2013

    ROTEM ex-tem Rest of the world part No: 503-05 (ROW)

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code JPA·July 23, 2019

    ROTEM ex-tem Canada Part No: 503-05-CA

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code JPA·July 23, 2019