9 results
·
36ms
·
Sources: EU EUDAMED, US FDA
MERKUR 4000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809665585042·MIS Fenestrated Screw, Ø10.5 x 75mm, Ø5.5mm Rod
MAGNETOM Free.Max, MAGNETOM Free.Star
FDA 510(k)
FDA Class 2
·Radiology
ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Death
·PHILIPS HEALTHCARE·Product code MKJ·December 8, 2010
CONFIRM
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code MXC·July 8, 2014
ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT
FDA Adverse Event
Malfunction
·UNOMEDICAL SDN BHD·Product code BTR·December 27, 2012
PROG VALVE INLINE W SG
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES MANSFIELD·Product code JXG·May 6, 2024
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021