10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EleGARD
FDA 510(k)
FDA Class 1
·General Hospital
Portex
FDA UDI
ICU MEDICAL, INC.·15019517085853·
CASPIAN Spinal System
FDA UDI
VB Spine LLC·10888857242616·Coronal Bender (Right) Size Ø3.5 mm
WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TI-MAX Z45
FDA 510(k)
FDA Class 1
·Dental
TRIDENT 0° X3 INSERT 36MM ID
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·November 3, 2014
COBAS E411 DISK SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CHP·August 24, 2011
4000CMS
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·July 5, 2013
OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML, MODEL# 221 901, OSSAPLAST ORTHO, 3.0ML, MODEL# 221 903
FDA 510(k)
FDA Class 2
·Orthopedic
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025