15 results
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19ms
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Sources: EU EUDAMED, US FDA
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