10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Endo Motor
FDA 510(k)
FDA Class 1
·Dental
STAINLESS STEEL SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Persona Revision Knee System Femoral Metaphyseal Cones
FDA 510(k)
FDA Class 2
·Orthopedic
SV1995-220829 RT PM-TMJ & MOD
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·March 18, 2025
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 30, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 23, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
GS
FDA Adverse Event
Malfunction
·LEONHARD LANG GMBH·Product code MKJ·April 12, 2023
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025