30 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD)
FDA 510(k)
FDA Class 2
·Dental
VK Couture
FDA UDI
Diversified Products, Inc.·00037741702160·
Aztec
FDA UDI
Aztecmed/Ent LLC·B87110212500·Barbara Straight Ear Pick
Disposable Mouthpiece 22mm OD
FDA UDI
Vacumed·00850644007213·cardboard mouthpiece
Cortera
FDA UDI
Xtant Medical Holdings, Inc.·00840311210305·Tap, Cann, 12.5
Vatech Clismile
FDA UDI
Rayence Co., Ltd.·08800018601433·This product is an orthodontic bracket and is u...
NA
FDA UDI
Summit Medical, Inc.·00385640001021·
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PipelineTM Vantage Embolization Device with Shield TechnologyTM
FDA UDI
Micro Therapeutics, Inc.·00847536036246·STENT PED3-021-250-16 V03 VANTAGE
PipelineTM Vantage Embolization Device with Shield TechnologyTM
FDA UDI
Micro Therapeutics, Inc.·00847536036260·STENT PED3-021-250-20 V03 VANTAGE
PipelineTM Vantage Embolization Device with Shield TechnologyTM
FDA UDI
Micro Therapeutics, Inc.·00847536036222·STENT PED3-021-250-12 V03 VANTAGE
PipelineTM Vantage Embolization Device with Shield TechnologyTM
FDA UDI
Micro Therapeutics, Inc.·00847536036253·STENT PED3-021-250-18 V03 VANTAGE
PipelineTM Vantage Embolization Device with Shield TechnologyTM
FDA UDI
Micro Therapeutics, Inc.·00847536036239·STENT PED3-021-250-14 V03 VANTAGE
PipelineTM Vantage Embolization Device with Shield TechnologyTM
FDA UDI
Micro Therapeutics, Inc.·00847536036215·STENT PED3-021-250-10 V03 VANTAGE
FREEDOM(TM) RINGLOC CONSTRAINED LINER 36MM / PLUS 5MM STANDARD FACE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWZ·October 6, 2016
RINGLOC + ACETABULAR SHELL LIMITED HOLE FINNED 56MM SIZE 24
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·October 6, 2016
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·September 22, 2021
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PED3-021-275-12, PED3-021-275-16, PED3-021-325-12, PED3-021-325-14, PED3-021-325-16, PED3-021-325-20, PED3-021-250-12, PED3-021-300-14, PED3-021-250-16, PED3-021-300-12, PED3-021-275-14, PED3-021-350-14, PED3-021-350-25, PED3-021-350-12, PED3-021-250-10, PED3-021-275-20, PED3-021-350-18, PED3-021-325-18, PED3-021-275-18, PED3-021-250-18, PED3-021-300-18; and Instructions for Use, Part: M056989CDOC2
FDA Recall
Open, Classified
·Micro Therapeutics, Inc.·Product code OUT·January 30, 2025
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PED3-021-275-12, PED3-021-275-16, PED3-021-325-12, PED3-021-325-14, PED3-021-325-16, PED3-021-325-20, PED3-021-250-12, PED3-021-300-14, PED3-021-250-16, PED3-021-300-12, PED3-021-275-14, PED3-021-350-14, PED3-021-350-25, PED3-021-350-12, PED3-021-250-10, PED3-021-275-20, PED3-021-350-18, PED3-021-325-18, PED3-021-275-18, PED3-021-250-18, PED3-021-300-18; and Instructions for Use, Part: M056989CDOC2
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics, Inc.·March 12, 2025