11 results
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19ms
·
Sources: EU EUDAMED, US FDA
AMERICAN CATHETER E.R.C.P. CANNULA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VARIAX
FDA UDI
Stryker GmbH·07613327468502·Plate Insert 2.0mm
DISPOSABLE PRESSURE MANOMETER
FDA 510(k)
FDA Class 2
·Anesthesiology
WBR-FHR, WBR-FWB
FDA 510(k)
FDA Class 2
·Radiology
VGXP XP INLK PRI TIB TRAY 65MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·August 6, 2018
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·April 17, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·February 2, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·December 20, 2010
VANGUARD XP-XP TIBIAL TRAY-INTERLOK
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 20, 2018
fastener, fixation, nondegradable, soft tissue
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 21, 2018
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020