11 results
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18ms
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Sources: EU EUDAMED, US FDA
GAMMA-FREE HORSE SERUM
FDA 510(k)
FDA Class 1
·Hematology
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·January 7, 2021
AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set
FDA 510(k)
FDA Class 2
·Hematology
PROSPACE PEEK IMPLANT 5 7X8X22MM
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code MAX·June 21, 2013
TSPACE PEEK IMPLANT 26X11X7MM
FDA Adverse Event
Malfunction
·AESCULAP IMPLANT SYSTEMS·Product code MAX·October 30, 2015
CAPSURE SP NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
CRE(TM) BALLOON DILATATION CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code KOG·October 7, 2010
SMARTSET GMV GENTAMICIN 40G
FDA Adverse Event
Injury
·DEPUY CMW ? REG. # 9610921·Product code LOD·December 6, 2012
Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 23, 2014
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012