12 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens ; OxyPure A (olifilcon A) Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens
FDA 510(k)
FDA Class 2
·Ophthalmic
Vanguard® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304272064·
NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND BLACK COLOR)
FDA 510(k)
FDA Class 1
·General Hospital
UNIVERSAL, AESTHETICA, NATEA, NATURA
FDA 510(k)
FDA Class 2
·Dental
SURETRAK II UNIVERSAL TRACKER, MEDIUM CLAMP
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code OLO·December 3, 2014
NAVIGATION STEALTHSTATION TOOL
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code OLO·September 27, 2018
CORTSCR Ø1.5 SELF-TAP L12
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·June 22, 2013
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 4, 2008
ACCESS 3 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·July 8, 2011
I-STAT CHEM8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JPI·December 17, 2024
Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813T
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·April 24, 2019
XP-XP Tibial Tray - Interlok 83 mm Item # 195759
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019