10 results
·
25ms
·
Sources: EU EUDAMED, US FDA
GENTAMICIN FLUROIMMUNASSAY KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Sklar®
FDA UDI
SKLAR CORPORATION·10649111297427·JACKSON TRACH TUBE #5-4 PIECES
BODY-JET
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ClearUP Sinus Pain Relief
FDA 510(k)
FDA Class 2
·Neurology
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·January 6, 2025
KOTEX NATURAL BALANCE
FDA Adverse Event
Malfunction
·KIMBERLY-CLARK CORPORATION - CONWAY MILL·Product code HEB·April 30, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 29, 2007
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 5, 2012
UNK LIQUID EMBOLIC
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KGG·August 13, 2025
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021