14 results · 38ms · Sources: EU EUDAMED, 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