12 results · 20ms · Sources: EU EUDAMED, 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