25 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Adani MammoScan
FDA 510(k)
FDA Class 2
·Radiology
AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
FORU KV10HB
FDA 510(k)
FDA Class 2
·Physical Medicine
RIVA STAR SILVER DIAMINE FLUORIDE
FDA Adverse Event
Injury
·SDI LIMITED·Product code LBH·February 13, 2019
PUSHING CATHETER
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·October 19, 2022
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 10, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011
LIFEPAK CR PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·September 18, 2008
FILIFORM DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·June 30, 2022
PUSHING CATHETER
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·September 15, 2023
FILIFORM DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·June 30, 2022
BLACK SILICONE FILIFORM DOUBLE PIGTAIL URETERAL STENT
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·January 31, 2023
PUSHING CATHETER
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·June 28, 2023
FILIFORM DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·January 2, 2020
PUSHING CATHETER
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·March 5, 2021
Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8;
FDA Enforcement
Class II
·Ongoing·Becton, Dickinson and Company·May 27, 2026
Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
FDA Enforcement
Class II
·Ongoing·AVID Medical, Inc.·September 17, 2025
Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 7, 2018
Affixus Hip Fracture Nail, 130 DEG 9MM X 180MM
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 7, 2018
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 460MM
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 7, 2018