11 results
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27ms
·
Sources: EU EUDAMED, US FDA
KERR XR BOND
FDA 510(k)
FDA Class 2
·Dental
SURGISTAR
FDA UDI
SURGISTAR, INC.·00878799008336·
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011880250000·Medium-Assortment dentaform® Snap Bands, Tooth ...
LEKSELL SURGIPLAN, MODEL 1006947
FDA 510(k)
FDA Class 2
·Neurology
HEMOPEXIN NEPHELOMETRIC ASSAYS
FDA 510(k)
FDA Class 2
·Immunology
ARGYLE SALEM SUMP TUBE WITH ANTI-REFLUX VALVE
FDA Adverse Event
Malfunction
·SHERWOOD DAVIS AND GECK·Product code KNT·August 29, 1996
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM Item Number: 11-301312
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·August 18, 2021
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 8, 2014
LAMITRODE 44 LEAD
FDA Adverse Event
Injury
·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·October 19, 2010
V60 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code MNT·December 19, 2012
Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model Number: 25001050E c. Male-Female Midsection, 60mm, 1 EACH; Model Number: 25001060E d. Male-Female Midsection, 70mm, 1 EACH; Model Number: e. Male-Female Midsection, 90mm, 1 EACH; Model Number: 25001090E f. Male-Female Midsection, 110mm, 1 EACH; Model Number: 25001110E g. Male-Female Midsection, 140mm, 1 EACH. Model Number: 25001140E Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025