16 results · 24ms · Sources: EU EUDAMED, US FDA

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ESTECH PERCUTANEOUS INSERTION DILATOR KIT

FDA 510(k)
FDA Class 2 ·Cardiovascular

RHIGENE MESACUP2 TEST- SSA

FDA 510(k)
FDA Class 2 ·Immunology

ELECTRO NEUROMUSCULAR STIMULATOR, MODEL NMS-DIGITAL

FDA 510(k)
FDA Class 2 ·Physical Medicine

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·October 30, 2014

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·September 14, 2017

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·December 17, 2014

NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code MEH·July 20, 2022

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·January 10, 2018

NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JDI·July 9, 2024

COBAS 6000 C501 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·April 22, 2013

ARCHITECT TOTAL B-HCG

FDA Adverse Event
Malfunction ·A.I.D.D LONGFORD·Product code DHA·April 27, 2011

M SERIES

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORP.·Product code MKJ·July 1, 2008

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·April 27, 2020

NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JDI·October 11, 2024

NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JDI·October 28, 2024

Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

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