20 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ISOLA BAND CLAMP
FDA 510(k)
FDA Class 2
·Orthopedic
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890109720·Zirlux Titanium Abutment 4.5 mmH compatible wit...
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00024021545005·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00024021559217·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00024021585940·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00024021755442·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00024021755077·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00024021544978·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00024021559187·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00024021585964·
ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS
FDA 510(k)
FDA Class 2
·Orthopedic
BD MICRO-FINE ULTRA¿ PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·September 28, 2018
MENTOR SMOOTH ROUND MODERATE PLUS PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·October 12, 2018
ENDOSCOPIC LINEAR CUTTER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·March 19, 2013
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 8, 2011
TENDRIL DX
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008
ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients
FDA Enforcement
Class II
·Terminated·Teleflex Medical·December 7, 2016
uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.
FDA Enforcement
Class II
·Terminated·Ulrich Medical USA Inc·May 3, 2017
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018