12 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPY Portable Handheld Imaging (SPY-PHI) System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·October 20, 2020
HARONIS ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH +ADAPTIVE TISSUE TECHNOLOGY HARMONIC ACE 5MM DIAMETER SHEARS 23
FDA 510(k)
FDA Unclassified
·Unknown
ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·October 16, 2020
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·June 12, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 21, 2025
(END) SCREW EXTENDER SLEEVE
FDA Adverse Event
Malfunction
·ABBOTT SPINE, INC.·Product code KWP·October 6, 2008
BARI10A ENHANCED BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 26, 2013
SYNCHROMED
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·July 26, 2011
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·October 13, 2021
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·August 19, 2019