7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SERO/TEX CRP TEST
FDA 510(k)
FDA Class 2
·Immunology
NuVasive Reline Cervical System
FDA 510(k)
FDA Class 2
·Orthopedic
CASHMERE NON-STERILE, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRAM
FDA 510(k)
FDA Class 1
·General Hospital
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 20, 2014
ABGII. MODULAR STEM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code KWY·October 23, 2012
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·August 25, 2010
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025