26 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Sleepware G3
FDA 510(k)
FDA Class 2
·Neurology
Conventional Lead Apron .5mm Xtra Xtra Large 26 X 42
FDA UDI
Flow X Ray Corporation·00843696123956·Conventional Lead Apron .5mm XXL 26 X 42, Antim...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112816·BARRON VACUUM PUNCH 9.0MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112717·BARRON VACUUM PUNCH 6.5MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112878·CORNEAL TREPHINE BLADE6.5MM
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·August 5, 2022
SALINE IV FLUSH SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
SpeediCath Soft
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ECHELON
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·March 23, 2021
ECHELON
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·March 23, 2021
UNKNOWN CHLORAPREP
FDA Adverse Event
Injury
·CAREFUSION 213, LLC 0113·Product code OJU·December 9, 2021
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
FDA Adverse Event
Malfunction
·STAAR SURGICAL CO.·Product code HQL·October 16, 2008
LIBERTY CYCLER SET DUAL PATIENT CONNECT
FDA Adverse Event
Malfunction
·REYNOSA MANUFACTURING·Product code FKX·June 28, 2013
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
LUCIRA CHECK-IT COVID-19 TEST
FDA Adverse Event
Malfunction
·PFIZER, INC.·Product code QJR·July 31, 2023
LUCIRA CHECK-IT COVID-19 TEST
FDA Adverse Event
Malfunction
·PFIZER, INC.·Product code QJR·July 31, 2023
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·March 1, 2022
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
FDA Adverse Event
Death
·HEARTWARE, INC.·Product code DSQ·March 1, 2022
MAGNETOM Vida Fit. Model Number: 11410481.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
SILK SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAP·April 3, 2023