8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
ABBOTT PREGNA-PLUS HUMAN CHORIONIC GONADOTROPIN EN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
WRIGHT STAIN BUFFER
FDA 510(k)
FDA Class 1
·Pathology
ARGYLE TAPERED VASCULAR SHUNT
FDA 510(k)
FDA Class 2
·Cardiovascular
12/14 ARTICUL 40MM M SPEC+8.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·June 3, 2014
DEPUY ASR XL FEM IMP SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 26, 2012
SMART CONTROL NITINOL STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code FGE·September 27, 2010
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
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