18 results · 23ms · Sources: EU EUDAMED, 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