13 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Quantum Blood and Fluid Warming System
FDA 510(k)
FDA Class 2
·General Hospital
CoRoent
FDA UDI
Nuvasive, Inc.·00887517639455·CoRoent Ant TLIF PEEK, 9x12x32mm 15°
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668111055·SILICONE MAT FOR K 9-2320
PIN SCREW
FDA UDI
BK MEDITECH CO.,LTD.·08809155854931·Wire Pin Screw, 2.3mm Shaft Diameter x 2.3mm Th...
MODIFICATION TO:CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 3, 2024
COPIOS PERICARDIUM MEMBRANE
FDA Adverse Event
Injury
·Product code NPL·June 10, 2020
ISOFLEX OPTIM LEAD
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code DTB·January 11, 2014
UNKNOWN M2A MAGNUM HIP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 27, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·December 19, 2024
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