17 results
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39ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Aveir Retrieval Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
3.75MM AND 5.0MM SPLINE TWIST IMPLANT
FDA 510(k)
FDA Class 2
·Dental
NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VIDEO MEDIASTINOSCOPE
FDA Adverse Event
Injury
·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021
VIDEO MEDIASTINOSCOPE
FDA Adverse Event
Injury
·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021
VIDEO MEDIASTINOSCOPE
FDA Adverse Event
Injury
·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021
BIO-PUMP
FDA Adverse Event
Death
·MEDTRONIC BIO-MEDICUS, INC.·Product code KFM·March 5, 1997
VIDEO MEDIASTINOSCOPE
FDA Adverse Event
Injury
·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021
PRECISE PRO RX CAROTID STENT SYSTEM
FDA Adverse Event
Malfunction
·CORDIS CORPORATION·Product code NIM·October 30, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011
UNK
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·July 9, 2013
IMPL TWIST MTX 3.75 MM 10 MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 17, 2024
ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311R
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·February 3, 2023
ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·February 3, 2023
ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·February 3, 2023
ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·February 3, 2023
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 22, 2026