11 results
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25ms
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Sources: EU EUDAMED, US FDA
ROVENSTEIN FORCEPS
FDA 510(k)
FDA Class 1
·Anesthesiology
Archon
FDA UDI
Nuvasive, Inc.·00887517303363·Archon Screw, 4.0x18mm S.T. Fixed Recon
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515148871·Elevator, #16, Angled, 6" (15cm)
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011880318220·dentaform® Snap, tooth 46,size 18/Roth 22
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011880318180·dentaform® Snap, tooth 46, size 18/Roth 18
ALMA LASER NIR MODULE
FDA 510(k)
FDA Class 2
·Physical Medicine
PET Digital Gating
FDA 510(k)
FDA Class 2
·Radiology
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 8, 2014
OCTRODE 8 PERCUTANEOUS TRIAL LEAD
FDA Adverse Event
Injury
·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·October 20, 2010
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE CANADA KIRKLAND·Product code IOR·December 19, 2012
a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. Component. of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025