14 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HARRIS MODEL 2000
FDA 510(k)
FDA Class 2
·Radiology
DGH-500 PACHYMETER
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
STERILMED, INC.·10888551007580·SAW BLADE SAGITTAL K9 K2000 SERIES
NA
FDA UDI
STERILMED, INC.·10888551007573·SAW BLADE SAGITTAL FLARED K9 K2000 SERIES
NA
FDA UDI
STERILMED, INC.·10888551007559·SAW BLADE SAGITTAL K9 K2000 SERIES
NA
FDA UDI
STERILMED, INC.·10888551007566·SAW BLADE SAGITTAL K9 K2000 SERIES
NA
FDA UDI
STERILMED, INC.·10888551007603·SAW BLADE SAGITTAL K9 K2000 SERIES
NA
FDA UDI
STERILMED, INC.·10888551007597·SAW BLADE SAGITTAL K9 K2000 SERIES
REAMER Ø11 F/PFNA BLADE
FDA Adverse Event
Malfunction
·SYNTHES·Product code HSB·January 22, 2013
SPRINT
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 14, 2010
QUICK FLEX LV LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·July 10, 2014
ABC HANDPIECE LAPAROSCOPIC
FDA Adverse Event
Malfunction
·CONSOLIDATED MEDICAL EQUIPMENT·Product code HAM·February 19, 2019
BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe is used in conjunction with an epidural needle with the purpose of finding the epidural space.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·October 2, 2013