88 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
CPC 8-Channel
FDA UDI
Noras MRI products GmbH·04251269200311·
N/A
FDA UDI
HANS RUDOLPH, INC.·00874750002733·7500L NIV 22ID ELB STDHDGR SS
Pilot Spinal System
FDA UDI
Life Spine, Inc.·00190837051549·Pilot Rod End Cap
UBM PLUS
FDA 510(k)
FDA Class 2
·Radiology
DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CATALYS LASER
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·January 24, 2024
CATALYS LASER
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·July 28, 2023
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 13, 2023
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 15, 2013
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014
TRILOGY ACETABULAR CONSTRAINED LINER
FDA Adverse Event
Injury
·ZIMMER INC·Product code KWZ·May 31, 2011
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·April 24, 2026
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·October 30, 2023
CATALYS SYSTEM
FDA Adverse Event
Injury
·AMO MANUFACTURING USA, LLC·Product code OOE·November 1, 2022
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·January 26, 2026
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 13, 2021
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 5, 2020
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·July 28, 2023
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·Product code OOE·October 12, 2021