Ophtec Usa Inc

FDA Filings

This page includes the latest FDA filings for Ophtec Usa Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Ophtec Usa Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number1062939
FEI Number3001237787
NameOPHTEC USA, INC.
Owner & OperatorOPHTEC BV
Contact AddressSchweitzerlaan 15
Groningen NL-GR Groningen 9728 NL
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address400 Sawgrass Corporate Parkway, Suite 220
Sunrise, FL 33325 US



FDA Filings

Device
Company
DeviceDate
OPHTEC USA, INC.
Capsular Tension Ring (CTR)2019-03-27
OPHTEC USA, INC.
RINGJECT2016-07-06
OPHTEC USA, INC.
CAPSULAR TENSION RING AND STABILEYES2015-11-13
OPHTEC USA, INC.
OPHTEC-STABLEYES CAPSULAR TENSION RING2012-03-12
OPHTEC USA, INC.
OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13US2011-12-14
OPHTEC USA, INC.
OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13US2004-04-27
OPHTEC USA, INC.
EASY CONTROL MICRO INSERTER, MODEL ON3852001-07-09

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