11 results
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18ms
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Sources: EU EUDAMED, US FDA
COULTER DACOS SERUM CHEM. ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DARCO SMALL SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
ACCOLADE C FEMORAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·May 9, 2014
PRECISION XTRA /OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·October 5, 2007
MANUAL CONTROLLED INFANT WARMER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·October 23, 2012
M/H RADIAL SOLID/APX SHL 52MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·February 25, 2019
GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022
BARDIA® FOLEY CATHETER SILICONE COATED
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON) -1018233·Product code KOD·May 23, 2024
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015