10 results
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33ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CHERRY SPONGE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Mini Twin
FDA UDI
Rmo, Inc.·00885797692184·STD EDG MINILP 018 W/O HK 5-5 20EA
PAQ.135X140X150*31*SCH.AT5
FDA UDI
AB MEDICA GROUP, S.A.·08428763009009·
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668110911·SQUEEZE HANDLE CLEANING TUBE
KAVO POLYLUX II
FDA 510(k)
FDA Class 2
·Dental
CANADY VIEIRA HYBRID PLASMA SCALPEL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 21, 2012
U1208 ULTRA SET CAPDDISCONNECT DISPOSABLE Y SET
FDA Adverse Event
Death
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·December 3, 2010
FLEXTEND II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code DTB·July 3, 2014
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