16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CHESAPEAKE (CERVICAL COMPONENTS)
FDA 510(k)
FDA Class 2
·Orthopedic
Needle Sleeve 13G,compl.
FDA UDI
Noras MRI products GmbH·04251269201950·
DONJOY
FDA UDI
DJO, LLC·00190446707325·ICEMAN CLASSIC3, W/ HIP-RIGHT WRAP-ON PAD, NS, RH
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089473724·
MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P
FDA 510(k)
FDA Class 2
·Anesthesiology
TOTAL ASR FEM IMP SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·May 14, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
FLEXICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·June 2, 2011
SPYSCOPE DS II ACCESS & DELIVERY CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FBN·September 30, 2020
SPYSCOPE DS II ACCESS & DELIVERY CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FBN·September 23, 2020
PANTHER FUSION ADV/HMPV/RV ASSAY
FDA Adverse Event
Injury
·HOLOGIC INCORPORATED·Product code OCC·October 12, 2021
PANTHER FUSION SARS-COV-2 ASSAY PPR SOLUTION
FDA Adverse Event
Malfunction
·HOLOGIC INCORPORATED·Product code QJR·October 11, 2021
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Catalog # 990061-070-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Enforcement
Class II
·Terminated·Oscor, Inc.·December 28, 2016
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025