10 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters
FDA 510(k)
FDA Class 2
·Cardiovascular
CoRoent
FDA UDI
Nuvasive, Inc.·00887517403827·CoRoent® XL, 16x18x60mm 10°
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981660·anteriors; shade D3 light; mould BIM2
RIA, DIGOXIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Acapella Choice Blue Vibratory PEP Device
FDA 510(k)
FDA Class 2
·Anesthesiology
UMBILICAL CATHETER
FDA Adverse Event
Malfunction
·VYGON·Product code FOS·February 17, 2021
VERTECEM V+ CEMENT KIT
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code NDN·February 27, 2013
MULTI-LINK VISION CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MAF·February 8, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·August 5, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021