12 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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3 LEAD EXTENSION WITH 2 INTERLINK INJECTION SITES
FDA 510(k)
FDA Class 2
·General Hospital
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100349·FEMTO SPECULUM FLAT WIRE
KUDO (POWERED ROTATION BED)
FDA 510(k)
FDA Class 2
·Physical Medicine
ANTIMICROBIAL SUSCEPT. TEST PANEL(TRIMETHOPRIM)
FDA 510(k)
FDA Class 2
·Microbiology
SERIES A PAT STD 31 3 PEG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HRY·October 31, 2018
ARROW EPIDURAL CATHETERIZATION SET
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code CAZ·May 28, 2014
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS·Product code GEX·January 9, 2013
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·November 3, 2010
BIOMET CRUCIATE TIBIAL TRAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HRY·April 4, 2018
VANGUARD POSTERIOR STABILIZED TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HRY·April 4, 2018
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023