9 results
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18ms
·
Sources: EU EUDAMED, US FDA
ENZYMUN-TEST ESTRADIOL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613023553·Kelly Scissors, Straight, Overall Length 7" (18...
SLIDEWIRETM(TRADEMARK PENDING)
FDA 510(k)
FDA Class 2
·Cardiovascular
14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH SPLIT-CATH, 14FX36CM ASH SPLIT-CATH, 14F X 40CM ASH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ESSURE
FDA Adverse Event
Injury
·BAYER·Product code HHS·June 27, 2014
COULTER LH 750 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code LOQ·December 2, 2010
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·January 14, 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
Pipeline Flex Embolization Device
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021