27 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112885·CORNEAL TREPHINE BLADE6.75MM
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113462·SCLEROTOME BLADE #57 (BX/5)
Cadwell
FDA UDI
Technomed Engineering B.V.·08720791377427·Disposable Hypodermic Needle Electrode, green hub
Technomed Europe
FDA UDI
Technomed Engineering B.V.·08718375865538·Disposable Hypodermic Needle Electrode, green hub
MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479
FDA 510(k)
FDA Class 2
·Microbiology
VITROS 5, 1 FS CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JJE·October 8, 2008
TRIATHLON PS X3 TIBIAL INSERT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS LIMERICK·Product code JWH·August 5, 2011
RESOLUTION CLIP CLIPPING DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·July 2, 2013
COBAS 8000 C (701) MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·March 16, 2017
COBAS 8000 C (701) MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·March 13, 2017
TRICLIP DELIVERY SYSTEM (TCDS)
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL·Product code NPS·June 26, 2024
1823260-2017-00824
FDA Adverse Event
Malfunction
·April 19, 2017
3.0 RIO ROBOTIC ARM - MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·October 8, 2019
MEDTRONIC CRT-D
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NIK·December 8, 2021
MEDTRONIC LEAD
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code DXY·December 8, 2021
MEDTRONIC ICD
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DXY·December 8, 2021
MEDTRONIC LEAD
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DXY·December 8, 2021
TRICLIP DELIVERY SYSTEM (TCDS)
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code NPS·June 26, 2024