11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE)
FDA 510(k)
FDA Class 1
·Hematology
ERBE ERBEJET 2 SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
SenoBright HD
FDA 510(k)
FDA Class 2
·Radiology
AMPLATZER SEPTAL OCCLUDER
FDA Adverse Event
Injury
·AGA MEDICAL CORPORATION·Product code MLV·October 31, 2019
AMPLATZER SEPTAL OCCLUDER
FDA Adverse Event
Injury
·AGA MEDICAL CORPORATION·Product code MLV·October 31, 2019
CERTAIN¿ TITANIUM LARGE HEXED SCREW
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·July 27, 2023
TI TRANSCONNECTOR 60MM
FDA Adverse Event
Malfunction
·SYNTHES (USA) BRANDYWINE·Product code KWP·February 15, 2013
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·January 24, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 31, 2014
CERTAIN¿ TITANIUM LARGE HEXED SCREW
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·July 27, 2023
Minor Pack, part number AMS3782(B Minor Pack, part number AMS3782(C Minor Pack, part number CMP1560 Minor Pack, part number PSS3518(B Minor Pack, part number PSS3541(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017