12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER
FDA 510(k)
FDA Class 2
·Dental
Starbond Easy
FDA UDI
S & S Scheftner GmbH·04260207854257·Disc, 18 mm ø 98,3 mm / with edging
icotec Cervical Cage, Anatomic Probe, 5 mm x 18 mm
FDA UDI
icotec AG·07640140438900·icotec Cervical Cage, Anatomic Probe, 5 mm x 18 mm
SELECT FABRICATORS, INC., AGMED TEX WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054
FDA 510(k)
FDA Class 2
·Cardiovascular
GMK-REVISION FEMORAL WEDGE POSTERIOR SIZE 3/10MM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code JWH·February 13, 2019
VALEO / VALEO II
FDA Adverse Event
Malfunction
·SINTX TECHNOLOGIES (FORMERLY AMEDICA CORP)·Product code MAX·March 25, 2020
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 31, 2013
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 3, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 27, 2011
TrueBeam Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.
FDA Recall
Terminated
·Vision RT Ltd Dove House, Arcadia Avenue London United Kingdom·Product code IYE·June 30, 2016
TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.
FDA Enforcement
Class II
·Terminated·Vision RT Ltd·August 31, 2016