21 results · 27ms · Sources: EU EUDAMED, US FDA

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XACT NEISSERIA

FDA 510(k)
FDA Class 1 ·Microbiology

Archon

FDA UDI
Nuvasive, Inc.·00887517304179·Archon Screw, 4.5x11mm S.T. Fixed Recon

Starter Kit Ventilation,neonatal

FDA UDI
Maquet Critical Care AB·07325710002933·Following Device Identifier number are included...

Mini-Sprint®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78805111·Mini Sprint Bracket Roth .022" max. 4+5 right

Mini-Sprint®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78805111001·Mini Sprint Bracket Roth .022" max. 4+5 right

Mini-Sprint®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78805110101·Mini Sprint Bracket Roth .022" max. 4+5 right

Mini-Sprint®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78805110051·Mini Sprint Bracket Roth .022" max. 4+5 right

Eon FR

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

PLEXUR-P

FDA 510(k)
FDA Class 2 ·Orthopedic

LinkSymphoKnee

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575257294·Patella Component, 3-peg

LinkSymphoKnee

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575257232·Patella Component, 3-peg

LinkSymphoKnee

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575257362·Patella Component, 3-peg

LinkSymphoKnee

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575257300·Patella Component, 3-peg

LinkSymphoKnee

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575257249·Patella Component, 3-peg

LinkSymphoKnee

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575257317·Patella Component, 3-peg

FOUNDATION SHOULDER INSTRUMENT

FDA Adverse Event
Malfunction ·ENCORE MEDICAL, L.P.·Product code HTQ·October 13, 2010

ELLIPSE VR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014

XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Death ·AV-TEMECULA-CT·Product code NIQ·December 19, 2012

Lumbar Laminectomy Pack, part number AMS2501 Lumbar Laminectomy Pack, part number AMS2501(A Lumbar Laminectomy Pack, part number AMS2501(B

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-20152-03M, FB-21152-03M. Component of ELEOS LIMB SALVAGE SYSTEM

FDA Enforcement
Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025