19 results · 27ms · Sources: EU EUDAMED, US FDA

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SPLITSCREEN (ME-975)

FDA 510(k)
FDA Class 1 ·Radiology

NA

FDA UDI
KEY SURGICAL, INC.·10849771049101·K-Wires, Single trocar, .062-inch (1.6mm) diame...

KMEDIC

FDA UDI
TELEFLEX INCORPORATED·24026704292763·

K-Wire w. trocar/round end 1.57mm/229mm, 6 pcs./unit

FDA UDI
mahe medical gmbh·EMAHKM711530·K-Wire w. trocar/round end 1.57mm...

mahe medical GmbH

FDA UDI
mahe medical gmbh·04050659484306·K-Wire w. trocar/round end _x000D_...

GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

DYNA ZYME II GOT 340

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SERVO-I

FDA Adverse Event
Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·April 29, 2014

840 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN, FORMERLY NELLCO·Product code CBK·February 1, 2013

KINAIR MEDSURG PULSE

FDA Adverse Event
Death ·KCI-USA, INC·Product code IOQ·January 14, 2011

AIA-900

FDA Adverse Event
Injury ·TOSOH CORPORATION·Product code KHO·February 24, 2016

PLEURX DRAINAGE KIT 500ML 10/CS

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code DWM·July 25, 2025

TOSOH AIA-900

FDA Adverse Event
Injury ·TOSOH CORPORATION·Product code KHO·December 13, 2016

A1A-600II

FDA Adverse Event
Injury ·TOSOH CORPORATION·Product code KHO·October 28, 2016

TOSOH AIA-1800

FDA Adverse Event
Injury ·TOSOH CORPORATION·Product code KHO·November 11, 2016

AIA-360

FDA Adverse Event
Injury ·TOSOH CORPORATION·Product code KHO·March 3, 2016

PLEURX DRAINAGE KIT 500ML 10/CS

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code DWM·December 24, 2024

PLEURX DRAINAGE KIT 500ML 10/CS

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code DWM·December 24, 2024

PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·October 25, 2017