25 results · 25ms · Sources: EU EUDAMED, US FDA

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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