2,714 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)
FDA 510(k)
FDA Class 2
·Cardiovascular
Oticon
FDA UDI
Oticon A/S·05714464008803·EARQ F30 MINIRITE R C063
MedDrain
FDA UDI
ARMM INC.·10850082007711·MedDrain 19 Fr Closed Wound Drain - Round 88 Eyes
36M - Class B 21 - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588620190·36M - Class B 21 - Metal
STREPTOCOCCUS APP. SEROLOGICAL REAGENTS
FDA 510(k)
FDA Class 1
·Microbiology
PERIFIX CATHETER CONNECTOR
FDA 510(k)
FDA Class 2
·Anesthesiology
Ambassador Cervical Plate System
FDA UDI
Choice Spine, LP·00840996161176·AMBASSADOR,DRILL,2.0x19
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 6, 2008
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·August 17, 2011
ALARIS PCA MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPA·July 3, 2013
FREERIDER
FDA Adverse Event
Injury
·FREERIDER CORP.·Product code INI·January 24, 2019
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 17, 2020
NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·May 21, 2019
NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
FDA Adverse Event
Malfunction
·COCHLEAR LTD·Product code MCM·May 22, 2019
ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM
FDA Adverse Event
Malfunction
·ZYNO MEDICAL, LLC·Product code FRN·August 27, 2019
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS LLC·Product code OYC·May 28, 2019
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS LLC·Product code OYC·April 23, 2019
UNK GEL BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·July 26, 2019
640G INSULIN PUMP MMT-1710K
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 26, 2022
UNK GEL BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·July 30, 2019