7 results
·
23ms
·
Sources: EU EUDAMED, US FDA
PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Excipio LV Thrombectomy Device
FDA 510(k)
FDA Class 2
·Cardiovascular
Pro M Class
FDA 510(k)
FDA Class 1
·Dental
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014
MP70 INTELLIVUE PATIENT MONITOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code DSI·July 29, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·July 23, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025