9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PUREGRAFT 50 SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SURELIFT PROLAPSE SYSTEM
FDA 510(k)
FDA Class 3
·Obstetrics/Gynecology
PRECISION SURGERY LIMITED VARIABLE AND FIXED CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC
FDA Adverse Event
Injury
·COOK INC·Product code LJS·December 3, 2015
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 29, 2025
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 29, 2013
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·September 29, 2014
ESPRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·June 17, 2011
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023