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LFR-260

FDA 510(k)
FDA Class 1 ·Ophthalmic

Foot Plates

FDA UDI
Trimed, INC.·00842188116575·LisfrancPlate,Rt,2.7/3.5mm,8-Hole,Small

Foot Plates

FDA UDI
Trimed, INC.·00842188116612·LisfrancPlate,Rt,2.7/3.5mm,8-Hole,Large

Foot Plates

FDA UDI
Trimed, INC.·00842188116599·LisfrancPlate,Rt,2.7/3.5mm,8-Hole,Medium

Alere Reader BinaxNOW Tray Pack

FDA UDI
Alere Scarborough, Inc.·10811877011016·A tray insert to be used with the Alere Reader ...

FiberTech®

FDA UDI
Weinert Fiber Optics, Inc.·00816901020661·

DIGIVAL Calibration Check Card Pack

FDA UDI
Alere Scarborough, Inc.·10811877010798·A calibration check card verifies that the DIGI...

NA

FDA UDI
Weinert Fiber Optics, Inc.·00816901022177·

NA

FDA UDI
Weinert Fiber Optics, Inc.·00816901022146·

FiberTech®

FDA UDI
Weinert Fiber Optics, Inc.·00816901020678·

NA

FDA UDI
Weinert Fiber Optics, Inc.·00816901022238·

FiberTech®

FDA UDI
Weinert Fiber Optics, Inc.·00816901020692·

Alere Reader Calibration Check Card

FDA UDI
Alere Scarborough, Inc.·10811877011009·A calibration check card verifies that the Aler...

NA

FDA UDI
Weinert Fiber Optics, Inc.·00816901022160·

NA

FDA UDI
Weinert Fiber Optics, Inc.·00816901022153·

DIGIVAL Tray Pack 1

FDA UDI
Alere Scarborough, Inc.·10811877011214·A tray insert to be used with the DIGIVAL to en...

FiberTech®

FDA UDI
Weinert Fiber Optics, Inc.·00816901020890·

FiberTech®

FDA UDI
Weinert Fiber Optics, Inc.·00816901020708·

FiberTech®

FDA UDI
Weinert Fiber Optics, Inc.·00816901020685·

DIGIVAL INSTRUMENT (OUS)

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code PSZ·October 15, 2025