11 results · 27ms · Sources: EU EUDAMED, US FDA

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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