27 results · 23ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

MODIFICATION TO: PRONTO DRY

FDA 510(k)
FDA Class 1 ·Microbiology

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496002451·NAOMI 140, SIZE S, FUMO, GRADUATED COMPRESSION ...

MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS

FDA 510(k)
FDA Class 2 ·Orthopedic

FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

RESTORE ADVANCED

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 7, 2013

RESTORE

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 7, 2013

STENT - VASCULAR RECONSTRUCTION

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code NJE·October 1, 2021

ECHELON

FDA Adverse Event
Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·August 26, 2021

REFLEX CATHETER

FDA Adverse Event
Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code DQY·August 26, 2021

MARKSMAN

FDA Adverse Event
Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·August 26, 2021

PIPELINE

FDA Adverse Event
Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·August 26, 2021

RESTORE ULTRA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 15, 2015

RESTORE ADVANCED

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 24, 2017

MITEK OMNISPAN MENISCAL REPAIR SYSTEM W/ 27 DEGREE NEEDLE

FDA Adverse Event
Malfunction ·DEPUY MITEK·Product code MBI·March 13, 2013

UNKNOWN DEPUY ASR HIP

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 18, 2011

PLUM XLM INT ENGLISH

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·July 9, 2014

UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code LGD·January 13, 2012

UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code LGD·January 13, 2012

APTIMA SARS-COV-2 ASSAY

FDA Adverse Event
Malfunction ·HOLOGIC INCORPORATED·Product code QJR·August 3, 2022

APTIMA SARS-COV-2 ASSAY

FDA Adverse Event
Malfunction ·HOLOGIC INCORPORATED·Product code QJR·August 3, 2022