18 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Microlife Upper Arm Automatic Digital Blood Pressure Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776302948·4 Prong Volkman Retractor, Blunt, 8.75", USA Pa...
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780165354·Integra® Jarit® Volkman Retractor, 9", USA Patt...
Navigator 3 Wireless Probe, 14 mm Angled
FDA UDI
crystal-photonics GmbH·04260152884507·gamma probe system, angled wireless probe
Navigator 3 WirelessPprobe, 13mm Straight
FDA UDI
crystal-photonics GmbH·04260152884491·gamma probe system, straight wireless probe
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTL.·Product code MNI·October 14, 2011
DELTA PROTR.LINER ØINT 36MM #L
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code LPH·May 29, 2023
DELTA PROTR.LINER ØINT 36MM #L
FDA Adverse Event
Malfunction
·LIMACORPORATE S.P.A.·Product code LPH·May 11, 2023
STAT PROFILE CRITICAL CARE XPRESS ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FUSION QUATTRO EXTRACTION BALLOON
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code GCA·December 10, 2024
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·November 11, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 17, 2014
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·August 11, 2011
PRECISION XTRA
FDA Adverse Event
Injury
·Product code NBW·July 1, 2013
FUSION QUATTRO EXTRACTION BALLOON
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code GCA·June 7, 2024
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021