12 results · 22ms · Sources: EU EUDAMED, US FDA

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syngo.CT Applications

FDA 510(k)
FDA Class 2 ·Radiology

NA

FDA UDI
DEPUY MITEK, LLC·10886705007301·Cortical Screw 4.5mm x 50mm

TriVerse Tibial Alignment Ankle Clamp

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215108953·

VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET; MODEL 108

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

SLEEP PROFILER

FDA 510(k)
FDA Class 2 ·Neurology

QUADRA R FEMORAL STEMS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·March 30, 2026

VAPR VUE GENERATOR

FDA Adverse Event
Malfunction ·DEPUY MITEK LLC US·Product code GEI·January 28, 2019

SYNCHROMED EL

FDA Adverse Event
Injury ·RICE CREEK MANUFACTURING·Product code LKK·November 4, 2008

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·August 23, 2011

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013

MECTACER BIOLOX OPTION HEADS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·October 7, 2025

Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018