10 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ReLine
FDA UDI
Nuvasive, Inc.·00195377063137·RELINE C Screw, 4.5x25mm Reduction Thor
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809665585110·MIS Fenestrated Screw, Ø4.5 x 25mm, Ø6.0mm Rod
MODIFIED FOLEY CATHETER/TEMPERATURE SENSOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
MEDTRONIC BIVENTRICULAR VIVA CRT
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code KRG·March 28, 2019
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 28, 2013
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 31, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 3, 2014
BD PYXIS¿ MEDSTATION¿ ES
FDA Adverse Event
Malfunction
·CAREFUSION 303, INC.·Product code BRY·March 31, 2025