22 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULA
FDA 510(k)
FDA Class 2
·Dental
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040013106·Zirlux 16+ C4 98.5X10
Endo Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964153075·Endo Carry-on Procedure Kit contains Intercept ...
SureFlex
FDA UDI
AMERICAN MEDICAL SYSTEMS·00878953000138·150 µm Lithotripsy Fiber
CATHERINE MALANDRINO
FDA UDI
FGX INTERNATIONAL INC.·00193033219218·
CATHERINE MALANDRINO
FDA UDI
FGX INTERNATIONAL INC.·00193033219027·
CATHERINE MALANDRINO
FDA UDI
FGX INTERNATIONAL INC.·00193033219041·
CATHERINE MALANDRINO
FDA UDI
FGX INTERNATIONAL INC.·00193033219034·
Intess L
FDA UDI
Kalitec Direct LLC·B07312K0100320·Assembly, Caddie, 30mm Lumbar Implants, Hinged
QUICK SET
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 27, 2025
RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SEED SELECTRON MODEL V. 1.0
FDA 510(k)
FDA Class 2
·Radiology
AXON PATIENT MODULE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code GWF·March 14, 2013
COLLEAGUE 3 TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP CE FRENC
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 8, 2011
TENDRIL SDX
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008
SYRINGE 50ML W/O
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·April 23, 2021
EXACTECH
FDA Adverse Event
Malfunction
·EXACTECH, INC.·Product code JWH·April 19, 2022
EXACTECH
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code LXH·May 19, 2022
OPTETRAK LOGIC
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 6, 2019
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025