13 results
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19ms
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Sources: EU EUDAMED, US FDA
FLEX TUBE
FDA 510(k)
FDA Class 1
·Anesthesiology
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011881230000·dentaform® Snap Band, Tooth 36, Size 30
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011881230180·dentaform® Snap Band, Tooth 36, Size 30/Roth 18
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011881230220·dentaform® Snap Band, Tooth 36, Size 30/Roth 22
Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lensfor ASTIGMATISM, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA
FDA 510(k)
FDA Class 2
·Ophthalmic
TRAUSON INTRAMEDULLARY NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
3RD BLADE HOLDER
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code GAD·July 18, 2019
DURATA STS OPTIM ACTIVE FIXATION LEAD, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code NVY·January 13, 2014
VERTE-STACK SPINAL SYSTEM
FDA Adverse Event
Malfunction
·SOFAMOR DANEK DEGGENDORF GMBH·Product code MQP·October 6, 2010
ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·November 14, 2012
M2A-MAGNUM MOD HD SZ 44MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·June 12, 2018
Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 4, 2018
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020