9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Normatec Elite Hip
FDA 510(k)
FDA Class 2
·Physical Medicine
Endo-Model Modular Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575045334·Proximal Tibial Spacer,Size large
3400E series; E5400 series; E6400 series; Sundazzler series
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UROPLASTY RIGID ENDOSCOPIC NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Death
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·November 14, 2014
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 16, 2011
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 25, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
FDA Enforcement
Class I
·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024