16 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BR-FHUS Viewer 1.0
FDA 510(k)
FDA Class 2
·Radiology
ClearFit
FDA UDI
LONGEVITI NEURO SOLUTIONS LLC·90855113008084·Extra Small Flat
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293968·
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·00849771015239·Steinmann Pins, Single diamond, threaded, 1/8-i...
NA
FDA UDI
KEY SURGICAL, INC.·10849771050039·Steinmann Pins, Single diamond, threaded, 1/8-i...
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100783·FLIERINGA FIXATION RING 17MM
ARTHROCARE SYSTEM 12000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LAMBERGSLEEPWELL- SMARTRUSION (LSW-S)
FDA 510(k)
FDA Class 2
·Dental
INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·February 9, 2026
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 14, 2014
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 16, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011
PERFORMER INTRODUCER
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·April 15, 2022
PERFORMER INTRODUCER
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·September 11, 2024
PERFORMER RADIAL ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·July 15, 2022
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021