11 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ClotTriever Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNCHROMED II
FDA Adverse Event
Death
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·March 21, 2013
INTESS CERVICAL CAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN
FDA 510(k)
FDA Class 2
·Dental
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 31, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·February 19, 2013
8015 ALARIS SYSTEM PC UNIT
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 18, 2020
INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 6, 2014
2520274-2013-04499
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HRS·July 18, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code OWB·November 18, 2015
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025