7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
EVOLVE Nitric Oxide Delivery System
FDA 510(k)
FDA Class 2
·Anesthesiology
I-PROMOTIONS CONTACT LENS CASE
FDA 510(k)
FDA Class 2
·Ophthalmic
KardiFlex NC Coronary Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 11, 2014
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code KWP·November 21, 2008
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 23, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025