BEUDAMED
    27 results · 22ms · 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.
    Filters Regulation: Us FDA ×

    CHIEF SR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471156036·K-WIRE - SINGLE TROCAR 0.9mm DIA x 230mm

    RESPICONNECT ADAPTER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NUCLEOTOME PROBE SET, MODEL 21200

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    URIC ACID REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code KNK·April 15, 2011

    DELTA CER HEAD 12/14 36MM +5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LZO·February 11, 2026

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·September 17, 2019

    I-STAT CHEM8+ CARTRIDGE (SEE H10 FOR EC8+)

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 7, 2017

    KII 12X100 FIOS Z-THREADED

    FDA Adverse Event
    APPLIED MEDICAL·Product code GCJ·January 30, 2013

    UPHOLD VAGINAL SUPPORT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·December 29, 2010

    COREVALVE 31MM AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 17, 2014

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·February 15, 2022

    I-STAT CARTRIDGE

    FDA Adverse Event
    Injury ·ABBOTT POINT OF CARE·Product code CHL·August 8, 2014

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·March 30, 2023

    I-STAT CG4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code KHP·January 5, 2022

    I-STAT CG4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code KHP·January 5, 2022

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

    Military Kit Portable Clinical Analyzer ; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood 510 K940918 Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K 001387

    FDA Enforcement
    Class II ·Terminated·Abbott Point Of Care Inc.·July 18, 2012

    iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels.

    FDA Enforcement
    Class II ·Terminated·Abbott Point Of Care Inc.·July 18, 2012