8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ROTAVIRUS ENZYME IMMUNOASSAY
FDA 510(k)
FDA Class 1
·Microbiology
Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GLAID OCULAR ELECTROPHYSIOLOGY DEVICE
FDA 510(k)
FDA Class 2
·Neurology
PRECISE PRO RX CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIM·June 2, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 23, 2012
MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)
FDA Adverse Event
Malfunction
·MEDTRONIC CARDIOVASCULAR·Product code MIH·September 22, 2010
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024