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

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MASCOT CW DOPPLER SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

N/A

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994287854·CASE 9871212 INNER

Key Surgical K-Wires and Steinmann Pins

FDA UDI
KEY SURGICAL, INC.·00849771012795·K-Wires, Double diamond, .045-inch (1.1mm) diam...

KMEDIC

FDA UDI
TELEFLEX INCORPORATED·24026704293043·

NA

FDA UDI
KEY SURGICAL, INC.·10849771049415·K-Wires, Double diamond, .045-inch (1.1mm) diam...

mahe medical GmbH

FDA UDI
mahe medical gmbh·04050659484559·K-Wire w. double end lanzet point _x000D_...

K-Wire w. double end lanzet point 1.1mm/229mm, 6 pcs./unit

FDA UDI
mahe medical gmbh·EMAHKM712120·K-Wire w. double end lanzet point 1.1mm/...

ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000

FDA 510(k)
FDA Class 2 ·Anesthesiology

AirFit N20

FDA 510(k)
FDA Class 2 ·Anesthesiology

EQUINOXE REVERSE 42MM HUMERAL LINER +0

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·September 28, 2023

PINNACLE MTL INS NEUT36IDX60OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·June 13, 2014

ENDOTAK RELIANCE

FDA Adverse Event
Malfunction ·CPI - DEL CARIBE·Product code NVY·October 15, 2010

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 12, 2012

Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

FDA Enforcement
Class I ·Terminated·Animas Corporation·April 10, 2013

PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP 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