10 results
·
21ms
·
Sources: EU EUDAMED, US FDA
THAYER-MARTIN MEDIUM WITH ANSIOMYCIN
FDA 510(k)
FDA Class 2
·Microbiology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110683·LUER ADAPTOR FOR IRRIGATION
LumiGlam Laser System (SHE-LSP601-3)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ONLINE VALPROIC ACID
FDA 510(k)
FDA Class 2
·Clinical Toxicology
INTELLIS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·June 23, 2025
SENSATION PLUS 50CC IAB
FDA Adverse Event
Death
·DATASCOPE CORP.·Product code DSP·April 8, 2014
STAIR PRO - MODEL 6252
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·September 19, 2012
ECLIPSE
FDA Adverse Event
Malfunction
·VARIAN MEDICAL SYSTEMS·Product code MUJ·July 14, 2010
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
Model Number U228, VISIONIST CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025