12 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Prophecy Preoperative Navigation Alignment System
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
Smith & Nephew, Inc.·03596010104250·4.0MM FULLY THREADED CANNULATED
...
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657006699·Freer Elevator
Sklar®
FDA UDI
SKLAR CORPORATION·10649111201776·SPENCER STITCH SCISS 3.5"
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
STEPHENS DISPOSABLE FORCEPS
FDA 510(k)
FDA Class 1
·Ophthalmic
ABBOTT SL2 SHEATH
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code DYB·March 10, 2025
ABBOTT SL1 SHEATH
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code DYB·March 10, 2025
VITROS 5,1 FS CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·November 6, 2008
GELPORT 120MM
FDA Adverse Event
APPLIED MEDICAL·Product code GAD·July 26, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 12, 2013
syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·September 22, 2021