7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VALPROIC ACID EIA TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DOCUMENT(R) REFLECTANCE I LINEARITY TEST SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MODIFIED PROTASUL 100 (TI-6A1-7NB) ALLOY
FDA 510(k)
FDA Class 2
·Orthopedic
5MM PEEK MULTIFUNCTION HANDLE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code KOG·January 22, 2013
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NEK·January 15, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 28, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024