8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
MAXXUS
FDA 510(k)
FDA Class 2
·Radiology
CROMATEST RHEUMATOID DIAGNOSTIC/RF LATEX TEST
FDA 510(k)
FDA Class 2
·Immunology
POWDER FREE, NON-STERILE, LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 14, 2010
S-ROM M HEAD 36MM +0
FDA Adverse Event
Injury
·DEPUY INTL., LTD.·Product code JDI·January 22, 2013
5MM MONOPOLAR HANDLE 33CM
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code KOG·July 10, 2014
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
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025