9 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Disposable Safety Lancet
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZESPIN SI Joint Fusion System
FDA UDI
Aegis Spine, Inc.·00840273321590·Locking Screw Ø8x55mm
STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM LESS THAN 50U/G OF GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
AXERA ACCESS SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SMR SHOULDER
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code PHX·July 16, 2025
HUDSON NEONATAL DUAL LIMB HEATED WIRE CIRCUIT
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BZO·November 5, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011
CODEMASTER XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code LDD·July 1, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025