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

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ORTHOFIX

FDA 510(k)
FDA Class 2 ·Orthopedic

OPTIMA CT660

FDA 510(k)
FDA Class 2 ·Radiology

SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1

FDA 510(k)
FDA Class 1 ·Physical Medicine

FLOEY CATHETER W TEMP

FDA Adverse Event
Injury ·DEGANIA SILICONE LTD·Product code DRF·October 17, 2017

FOLEY CATHETER W TEMP

FDA Adverse Event
Malfunction ·DEGANIA SILICONE LTD.·Product code DRF·August 10, 2017

FOLEY CATHETER W TEMP

FDA Adverse Event
Malfunction ·DEGANIA SILICONE LTD.·Product code DRF·August 10, 2017

FOLEY CATHETER W TEMP

FDA Adverse Event
Malfunction ·DEGANIA SILICONE LTD.·Product code KOD·July 7, 2017

PROTAPER NEXT NITIFILE X1 21MM

FDA Adverse Event
Malfunction ·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EKS·February 6, 2025

PROTAPER NEXT NITIFILE X1 21MM

FDA Adverse Event
Malfunction ·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EKS·February 6, 2025

COULTER LH 500 HEMATOLOGY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code GKZ·May 25, 2014

RESTORE

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 14, 2012

DURATA STS OPTIM ACTIVE FIXATION

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 11, 2010

FOLEY CATHETER W TEMP

FDA Adverse Event
Malfunction ·MMJ SA DE CV (USD)·Product code DRF·November 9, 2018

8CM ANGLE ATTACHMENT, BLACK, MAX

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 9, 2014

XMAX MOTOR

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code ERL·March 31, 2015