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FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS

FDA 510(k)
FDA Class 2 ·Anesthesiology

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·00304040013359·Zirlux 16+ 0M1 98.5X14

MaXcess

FDA UDI
Nuvasive, Inc.·00887517064882·MaXcess Decomp Kerrison, 2mm 40° Curved

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450218563·

GeoShapes™ Elastics

FDA UDI
Ortho Organizers, Inc.·00190707097356·GeoShapes™ Elastics 5/16" (7.94 mm) Heavy 4.5oz...

Ovation

FDA UDI
Ortho Development Corporation·00822409121311·Narrow Stem Size 4 EXT

MASEL

FDA UDI
Ortho Organizers, Inc.·00190707053833·GeoShapes™ Elastics 5/16" (7.94 mm) Heavy 4.0oz...

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033273418·

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033273401·

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033273425·

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033273395·

NIDO Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07315K0112040·Tap, 5.50mm

INSET I

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 7, 2025

EXEL I.V. ADMINISTRATION SET

FDA 510(k)
FDA Class 2 ·General Hospital

GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

16CM MIN. INVASIVE ATTACHMENT

FDA Adverse Event
Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·March 29, 2013

INSET

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 22, 2025

INSET

FDA Adverse Event
Malfunction ·UNOMEDICAL S.A DE C.V·Product code FPA·October 9, 2025

INSET

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 22, 2025

PYRAMESH C TITANIUM MESH

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC, INC.·Product code EZX·August 12, 2011