8 results
·
51ms
·
Sources: EU EUDAMED, US FDA
Lombart Instrument, Inc. d/b/a Marco Ophthalmic
FDA registration
Lombart Instrument, Inc. d/b/a Marco Ophthalmic·2 products·🇺🇸 United States
COUNTER BALANCE KERATOMETER
FDA Adverse Event
Malfunction
·MARCO OPHTHALMIC INC.·Product code HJB·February 13, 2012
OPD - SCAN III
FDA Adverse Event
Injury
·MARCO OPHTHALMIC INC.·Product code HOX·October 2, 2018
AUTO REF/KERATOMETER ARK-1s
FDA Recall
Terminated
·Nidek Inc.·Product code HKO·December 20, 2017
Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye. Distributed by Nidek, Inc, and Marco Opthalmic Inc. Manufactured by Nidek Co. Ltd, Japan.
FDA Enforcement
Class II
·Terminated·Nidek Inc·July 9, 2014
Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye. Distributed by Nidek, Inc, and Marco Opthalmic Inc. Manufactured by Nidek Co. Ltd, Japan.
FDA Recall
Terminated
·Nidek Inc·Product code HKI·June 16, 2014
ZEE
FDA Adverse Event
MARCO OPTHALMIC. INC.·Product code HRJ·March 6, 1997
CMC Medical Devices & Drugs SL
Authorized representative
🇪🇸 Spain·698 Manufacturers·11260 Devices