19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SYMPHONY GRAFT DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Dental
SCANLAN®
FDA UDI
SCANLAN INTERNATIONAL INC·00846159028805·Dennis Multi-Purpose Clamp
ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BRAHMS DIAGNOSTICA LUMITEST ANTI-TG
FDA 510(k)
FDA Class 2
·Immunology
SYNERGY VERSITREL
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·February 24, 2017
TRIAGE CARDIAC TRIPLE MARKER PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code MMI·October 12, 2018
TRIAGE CARDIAC HS PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code MMI·October 22, 2019
TRIAGE CARDIAC TRIPLE MARKER PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR, INC.·Product code MMI·May 18, 2018
TRIAGE CARDIAC PANEL KIT
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR, INC.·Product code JHX·April 18, 2018
TRIAGE CARDIAC HS PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code MMI·October 21, 2019
TRIAGE CARDIAC TRIPLE MARKER PANEL
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code MMI·October 5, 2017
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·February 28, 2011
DAMON COPPER NITI WIRE
FDA Adverse Event
Malfunction
·ORMCO CORP.·Product code DZC·February 27, 2008
TRIAGE CARDIAC TRIPLE MARKER PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code MMI·November 1, 2018
TRIAGE CARDIAC TRIPLE MARKER PANEL
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code MMI·May 17, 2017
bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025