8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRECISION OSTEOLOCK ACETABULAR COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
MB SYSTEM, BIOENERGY LIGHT THERAPY
FDA 510(k)
FDA Class 2
·Physical Medicine
QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
45 CM, 5 FR. S/L POWER GROSHONG, BASIC KIT
FDA Adverse Event
Malfunction
·C. R. BARD INC. (BASD)·Product code LJS·November 18, 2010
OT ULTRA EASY METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 25, 2013
KII 12X100 FIOS Z-THREADED
FDA Adverse Event
Injury
·APPLIED MEDICAL·Product code GCJ·July 11, 2014
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