12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Intense Pulsed Light Treatment System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Echo® Bi-Metric® Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868274046·
Echo FX™ Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868260964·
ECHO BI-METRIC HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304512122·
ZUMA-C
FDA 510(k)
FDA Class 2
·Orthopedic
PANTINO PRO POSITINER
FDA 510(k)
FDA Class 2
·Dental
AEQUALIS STEM FOR FRACTURE D.6.5 HA-COATED
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·January 5, 2026
BURR-ATTACHM S F/EPD+APD
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·October 22, 2014
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·August 5, 2011
EGIA 60 ARTICULATING MED/THICK SULU
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY US SURGICAL·Product code GDW·June 19, 2013
bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
FDA Enforcement
Class II
·Terminated·Beaver-Visitec International Inc.·February 7, 2018
VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018