30 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TrusFIL Universal Composite Restorative
FDA 510(k)
FDA Class 2
·Dental
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112540·BARRON VACUUM TREPHINE 8.75MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112533·BARRON VACUUM TREPHINE 8.5MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112557·BARRON VACUUM TREPHINE 9.0MM
BIOTRACE, MODEL 1730
FDA 510(k)
FDA Class 2
·Neurology
SAFEPRO SAFETY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code MIH·March 29, 2022
CONFIRM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code MXC·September 16, 2020
OLYMPUS
FDA Adverse Event
Malfunction
·GYRUS ACMI·Product code GCJ·October 10, 2008
LUGE - 0.014 IN X300CM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORP·Product code DQX·August 5, 2011
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON ¿ IRVINE TECHNOLOGY CENTER·Product code HQC·June 28, 2013
GORE VIABAHN ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code PFV·August 3, 2020
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·January 12, 2021
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
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
BD PLASTIPAK ¿ - 3-PIECE SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·May 22, 2023
CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS
FDA Adverse Event
Death
·W. L. GORE & ASSOCIATES, INC.·Product code MIH·July 30, 2020
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·May 23, 2022
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·February 14, 2024
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·March 8, 2024