12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Sonic
FDA UDI
Sonic Innovations, Inc.·05711583032948·ET20, KIT 312 NFM 75 R BE ENCHANT 20
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123809·K-WIRE - DOUBLE TROCAR 1.4mm DIA x 100mm
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365114434·
AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ISOFLEX OPTIM LEAD
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CRMD·Product code DTB·January 13, 2014
UNKNOWN M2A MAGNUM HIP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 27, 2013
FREESTYLE FREEDOM LITE
FDA Adverse Event
Injury
·Product code NBW·August 4, 2011
MEDTRONIC TRANSCATHETER VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·February 8, 2022
1.8MM DRILL BIT/QC/125MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code DZI·June 27, 2014
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide 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