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:

• Abraham Farhan

FDA Registration(s)

• Registration Number: 1062939
• FEI Number: 3001237787
• Name: OPHTEC USA, INC.
• Owner & Operator: OPHTEC BV
• Contact Address: Schweitzerlaan 15 ; Groningen NL-GR Groningen 9728 NL
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 400 Sawgrass Corporate Parkway, Suite 220 ; Sunrise, FL 33325 US

FDA Filings

Device Company	Device	Date
PMA P030023S007 OPHTEC USA, INC.	Capsular Tension Ring (CTR)	2019-03-27
PMA P030023S005 OPHTEC USA, INC.	RINGJECT	2016-07-06
PMA P030023S004 OPHTEC USA, INC.	CAPSULAR TENSION RING AND STABILEYES	2015-11-13
PMA P030023S002 OPHTEC USA, INC.	OPHTEC-STABLEYES CAPSULAR TENSION RING	2012-03-12
PMA P030023S001 OPHTEC USA, INC.	OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13US	2011-12-14
PMA P030023 OPHTEC USA, INC.	OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13US	2004-04-27
PMN K011498 OPHTEC USA, INC.	EASY CONTROL MICRO INSERTER, MODEL ON385	2001-07-09

Similar & Related FDA Registered Companies

• OPHTEC USA, INC.6421 Congress Ave., Suite 112boca Raton, FL 33487 PMA NumberP030023 Supplement NumberS008 Date Received02/08/2022 Decision Date07/21/2022 Product Code MRJ  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	6RZ58	OPHTEC USA INC
CAGE Code	6RZ58	OPHTEC USA INC
S.A.M. Registration	6RZ58 [9593075]	OPHTEC USA INC