41 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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The AIO Solution 3.0
FDA 510(k)
FDA Class 2
·Radiology
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112540·BARRON VACUUM TREPHINE 8.75MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112519·BARRON VACUUM TREPHINE 8.0MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112533·BARRON VACUUM TREPHINE 8.5MM
TUBING, DIALYSATE (AND CONNECTOR)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ORG-9200A
FDA 510(k)
FDA Class 2
·Cardiovascular
Trabecular Metal®
FDA UDI
Zimmer, Inc.·00889024119116·
Trabecular Metal®
FDA UDI
Zimmer, Inc.·00889024119109·
Trabecular Metal®
FDA UDI
Zimmer, Inc.·00889024119123·
SURGICEL ABSORBABLE HEMOSTAT UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code LMG·September 2, 2021
ACCU-CHEK PERFORMA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE, INC.·Product code NBW·June 29, 2020
TRANSVENE
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWS·August 10, 2009
VALIANT STENT GRAFT
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·October 28, 2020
VALIANT STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·October 28, 2020
OXIMAX N-595 PULSE OXIMETER
FDA Adverse Event
Malfunction
·COVIDIEN FORMERLY TYCO HEALTHCARE·Product code DQA·October 15, 2008
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011
PHYSIOMESH OVAL
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·July 2, 2013
Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
FDA Enforcement
Class II
·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013
Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
FDA Recall
Terminated
·Surgical Instrument Service And Savings, Inc.·Product code HRH·May 3, 2013
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·January 12, 2021