7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
P-1 ULTRASONIC ARTERIOGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
LenSX Laser System
FDA 510(k)
FDA Class 2
·Ophthalmic
AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FLEXTEND II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code DTB·April 21, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 26, 2012
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·May 9, 2015
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026