26 results · 24ms · Sources: EU EUDAMED, US FDA

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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