24 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)
FDA 510(k)
FDA Class 2
·Physical Medicine
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112939·CORNEAL TREPHINE BLADE8.0MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112991·CORNEAL TREPHINE BLADE16MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112779·BARRON VACUUM PUNCH 8.0MM
INJEX 30 NEEDLE FREE INJECTION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
ELECSYS HCG TEST SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code MEA·August 8, 2023
GE OEC 7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 16, 2008
EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code ESW·June 28, 2013
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Injury
·BECKMAN COULTER, INC.·Product code MMI·August 5, 2011
UNK MAMMARY IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·November 10, 2021
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·June 14, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·June 14, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·June 21, 2022
Blue OR Towels, X-Ray Detectable, Sterile, 2 Towels per/pk; 48pk/Cs and 4 Towels per/pk; (20pk/Cs). Intended for packing and absorption externally or within patient wounds in various procedures or surgical cases.
FDA Enforcement
Class II
·Ongoing·Medical Action Industries Inc·May 24, 2017
UNKNOWN CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code JXG·June 3, 2022
UNKNOWN CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code JXG·June 3, 2022
UNKNOWN CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code JXG·June 3, 2022
ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code MIH·December 7, 2021
UNKNOWN CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code JXG·June 3, 2022