9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CUSTOMED ANGIODRAPE PACK FEMORAL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ORA Implant Abutment 5.0mm Cuff (AK)
FDA UDI
STERNGOLD DENTAL LLC·00841549113147·The ORA System is indicated for use with dental...
CASTABLE ABUTMENTS
FDA 510(k)
FDA Class 2
·Dental
SPEC(TM) EXTRACTION CARTRIDGE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
GMK HINGE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·September 30, 2025
LIBERTY CYCLER SET, SINGLE CONN/EXT DL
FDA Adverse Event
Malfunction
·REYNOSA MANUFACTURING·Product code FKX·January 4, 2013
GALILEO ECHO
FDA Adverse Event
Malfunction
·IMMUCOR·Product code KSZ·November 22, 2010
HUDSON CONCHA NEPTUNE
FDA Adverse Event
Malfunction
·TELEFLEX·Product code BTT·May 27, 2014
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013