12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HELENA FACTOR VII DEFICIENT SUB. PLASMA
FDA 510(k)
FDA Class 2
·Hematology
DRIVEMEDICAL
FDA UDI
Drive Devilbiss Healthcare·50050428502179·Walkers, All TypesAccessories Product Descripti...
SpineWand
FDA UDI
MORGAN STEER ORTHOPAEDICS LIMITED·05060696460019·Perc DLG Convenience Pack inc 17 gauge 8” Crawf...
Coblation
FDA UDI
Smith & Nephew, Inc.·00817470004489·PERC DLG
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198741·AK3 Ultra Insert Trial Size 5, 11mm
Venner PneuX TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX TT (Tracheostomy Tube) Size 9.0 mm
FDA 510(k)
FDA Class 2
·Anesthesiology
MOBILE X-RAY UNIT
FDA 510(k)
FDA Class 2
·Radiology
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 18, 2014
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·October 16, 2012
INSYNC II MARQUIS
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NIK·August 11, 2010
5.0MM TI LOCKING SCREW W/T25 STARDRIVE 26MM F/IM NAIL-STER
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code HWC·August 4, 2016
Minor Pack AMS1374(A, CMP1560, PSS3517, PSS3517(A, PSS3518, PSS3518(A, PSS3541, and PSS3541(A. convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016