9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PAJUNK STANDARD SPROTTE NEEDLE W/ INTRODUCER CANN.
FDA 510(k)
FDA Class 2
·Anesthesiology
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668111031·INSTRUMENT CADDY LARGE
N/A
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024368811·ZIMMER SPREADER BLOCK WIDTH 3 INCHES
Banded Face Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IMAGECHECKER-CT WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·January 18, 2013
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·December 13, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 9, 2014
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-116/00
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·August 16, 2023