19 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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everX Posterior
FDA 510(k)
FDA Class 2
·Dental
Walgreens
FDA UDI
WALGREEN CO.·00311917142098·Surgical Dressing. 5 IN X 9 IN.
IPLAN
FDA 510(k)
FDA Class 2
·Neurology
SOMATOM DEFINITION AS
FDA 510(k)
FDA Class 2
·Radiology
ONE TOUCH BASIC
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·December 12, 2002
AMPLATZER AMULET
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code NGV·May 23, 2023
SECURA DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 8, 2013
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·June 17, 2011
POLYFLUX LR CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIALYSATOREN GMBH·Product code MSF·September 4, 2008
HEMOSIL HIT-AB(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025
HEMOSIL HIT-AB(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025
MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code NKM·May 9, 2024
MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
FDA Adverse Event
Death
·ABBOTT MEDICAL·Product code NKM·May 9, 2024
MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code NKM·February 10, 2023
AMPLATZER AMULET
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL·Product code NGV·June 26, 2023
AMPLATZER AMULET
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code NGV·June 22, 2023
HEMOSIL HIT-AB(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025
iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·July 16, 2014