24 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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visor2 system
FDA 510(k)
FDA Class 2
·Neurology
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319744369·Cottle Skin Hook 5-1/2" (13.8cm), small deep cu...
Dilator, Vascular, acc. Garrett 14cm 4.5mm
FDA UDI
Geister Medizintechnik GmbH·04057034046692·Dilator, Vascular, acc. Garrett
14cm 4...
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0101090·Distractor, Smooth Paddle, Lordotic, 9mm
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0101090·Distractor, Smooth Paddle, 9mm
B-P TOTAL HIP SYSTEM
FDA UDI
ENDOTEC, INC.·00814193024763·B-P HIP MODULAR FEMORAL STEM W/O HEAD, W/ BIOCO...
Dilator, Vascular, acc. Garrett 14cm 4.5mm
FDA UDI
Geister Medizintechnik GmbH·04057034046715·Dilator, Vascular, acc. Garrett
14cm 4...
Garrett Vascular Dilator 14cm 4.5mm
FDA UDI
Geister Medizintechnik GmbH·04057034046708·Garrett Vascular Dilator 14cm 4.5mm
SUPER SEAL TOOTH DESENSITIZER
FDA 510(k)
FDA Class 2
·Dental
FLUOROPERM 151-OK, PARAGON HDS 100-OK
FDA 510(k)
FDA Class 2
·Ophthalmic
BD SYRINGE LUER-LOK TIP BULK STERILE CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·April 16, 2021
BD LUER-LOK¿ TIP SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·September 20, 2023
EASYPOINT NEEDLE
FDA Adverse Event
Injury
·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·February 9, 2023
EASYPOINT NEEDLE
FDA Adverse Event
Injury
·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·February 9, 2023
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·October 17, 2008
TRIMA ACCEL ENHANCED PLT, PLS, RBC SET
FDA Adverse Event
Other
·CARIDIANBCT·Product code LKN·August 5, 2011
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013
Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001
FDA Enforcement
Class I
·Ongoing·Whele LLC DBA Perch·November 30, 2022
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 19, 2023
Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No. M00326010 REF 2601, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
FDA Enforcement
Class II
·Terminated·Stryker Neurovascular·November 6, 2019