50 results · 32ms · Sources: EU EUDAMED, US FDA

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Catalys Precision Laser System

FDA 510(k)
FDA Class 2 ·Ophthalmic

OPHTHALMIC FEMTOSECOND LASER

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·February 9, 2021

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·January 11, 2021

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·January 11, 2021

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·March 5, 2021

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·March 5, 2021

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·February 16, 2021

CATALYS PRECISION LASER SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·February 8, 2021

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·January 19, 2021

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·January 19, 2021

CATALYS PRECISION LASER SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·February 8, 2021

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·January 19, 2021

CATALYS PRECISION LASER SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·February 12, 2021

Zirlux

FDA UDI
HENRY SCHEIN, INC.·00304040187562·ZIRLUX ML DISC C2 98x14 Ea

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112496·BARRON VACUUM TREPHINE 7.5MM

OsteoMed

FDA UDI
OSTEOMED LLC·00845694005852·Trocar, Short Pointed Cannula

BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DUET SUTURE ANCHOR

FDA 510(k)
FDA Class 2 ·Orthopedic

BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·May 11, 2023

Trilogy®

FDA UDI
Zimmer, Inc.·00889024118140·