12 results · 36ms · Sources: EU EUDAMED, 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