18 results
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17ms
·
Sources: EU EUDAMED, US FDA
PRIMROSE FEMALE EXT. CATH OR EXT. URINARY DRAINAGE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690196433·AK3 Tibial Instruments Pan
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690195146·AK3 Tibial Instruments Pan Insert
BriefCase
FDA 510(k)
FDA Class 2
·Radiology
ANALYZER, IMPACT 200
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Lens, Contact (Other Material) - Daily
FDA Pre-Market Approval
FDA Class 2
·ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS
Lens, Contact (Other Material) - Daily
FDA Pre-Market Approval
FDA Class 2
·ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS
Lens, Contact (Other Material) - Daily
FDA Pre-Market Approval
FDA Class 2
·ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS
Lens, Contact (Other Material) - Daily
FDA Pre-Market Approval
FDA Class 2
·ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS
Lens, Contact (Other Material) - Daily
FDA Pre-Market Approval
FDA Class 2
·ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS
Lens, Contact (Other Material) - Daily
FDA Pre-Market Approval
FDA Class 2
·ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS
Lens, Contact (Other Material) - Daily
FDA Pre-Market Approval
FDA Class 2
·ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS
Lens, Contact (Other Material) - Daily
FDA Pre-Market Approval
FDA Class 2
·ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS
Lens, Contact (Other Material) - Daily
FDA Pre-Market Approval
FDA Class 2
·ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·June 24, 2014
VITROS CHEMISTRY PRODUCTS PHYT SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code DIP·November 3, 2010
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 28, 2012
The Livongo Health In Touch¿ Blood Glucose Monitoring System (BGMS), is an Over-The-Counter (OTC) system designed for the self- monitoring of blood glucose by persons with diabetes in home settings to aid in their diabetes management.
FDA Enforcement
Class II
·Terminated·Livongo Health·May 11, 2016