10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QUANTIMUNE ESTRIOL RIA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
A-FIT®
FDA UDI
Gc Orthodontics America Inc.·E53581170900001·A-FIT® 2. MOLAR UPR RGT SZ 09
FOUNDATION DENTAL RESIN
FDA 510(k)
FDA Class 2
·Dental
UNI-GOLD STREP A TEST KIT
FDA 510(k)
FDA Class 1
·Microbiology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 15, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
SENSAR
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQL·June 2, 2015
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·August 20, 2013
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·August 20, 2013
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024