9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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