14 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MULTIX Impact, MULTIX Impact C
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668101179·GILL CORNEAL KNIFE STRAIGHT
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702827460·ELVAREX 3/KNEE HIGH/SLANT-OPEN TOE-ELEPHANTIASI...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702421330·ELVAREX 3/THIGH HIGH/CLOSED TOE, KNEE FUNCTION/...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523143245·R PS Cemented Femoral Component Sz 7
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523148110·PS Femoral Trial Sz 7 R
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523124374·CR Femoral Trial Sz 7 R
VIAVALVE SAFETY IV CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
ORTHOSIS HELMET MOLDING
FDA 510(k)
FDA Class 2
·Neurology
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·October 23, 2008
SYNCHRON® LX20 PRO
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·August 17, 2011
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 9, 2013
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025