9 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPIROX INEX DEVICE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003
FDA 510(k)
FDA Class 2
·Cardiovascular
G7 VIT E NEUTRAL LNR 36MM D
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·March 9, 2026
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·September 27, 2023
CADD SOLIS AMBULATORY INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL MD (FORMERLY DELTEC, INC)·Product code MEA·July 21, 2011
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 6, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 18, 2013
GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000
FDA Enforcement
Class I
·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024