9 results · 19ms · Sources: EU EUDAMED, US FDA

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SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI

FDA 510(k)
FDA Class 1 ·Microbiology

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

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

SAGITTAL SAW ATTACHMENT

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·June 19, 2014

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code NBW·October 26, 2010

ORTHOVISION TABLE

FDA Adverse Event
STERIS CORPORATION - MONTGOMERY·Product code JEB·December 21, 2012

LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA POR; and Custom devices Item Nos. 114754 114755 114744 114745 114704 114705 114756 114757 114714 114715 114746 114747 114706 114707 114758 114759 114716 114717 114748 114749 114708 114709 114718 114719 CP561429 CP561430 CP561431 CP561432 CP561442 CP561449 CP561488 CP561489 CP561709 CP561710 CP561714 CP561715 PM555203 Product Usage: Total Elbow Replacement

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019