Berlin Heart Inc

FDA Filings

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

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

FDA Registration(s)
Registration Number3008454189
FEI Number3008454189
NameBERLIN HEART, INC.
Owner & OperatorBerlin Heart, Inc.
Contact Address9391 Grogan's Mill Road Suite A-6
The Woodlands TX 77380 US
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address9391 Grogan's Mill Road Suite A-6
The Woodlands, TX 77380 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Berlin Heart Inc.
EXCOR blood pumps with Injection Molded Housing2020-05-06
Berlin Heart Inc.
Excor Pediatric Ventricular Assist2019-11-03
Berlin Heart Inc.
Excor Pediatric Ventricular Assist2019-11-03
Berlin Heart Inc.
EXCOR Pediatric Ventricular Assist2019-10-23
Berlin Heart Inc.
EXCOR Pediatric Ventricular Assist2019-09-18
Berlin Heart Inc.
EXCOR Pediatric Ventricular Assist2019-08-05
Berlin Heart Inc.
EXCOR Pediatric Ventricular Assist2018-10-26
Berlin Heart Inc.
EXCOR Pediatric Ventricular Assist2018-05-21
Berlin Heart Inc.
EXCOR Blood Pump2018-01-31
Berlin Heart Inc.
EXCOR Pediatric Ventricular Assist2017-08-02
BERLIN HEART, INC.
EXCOR? Pediatric Ventricular Assist Device2017-06-30
Berlin Heart Inc.
EXCOR Pediatric Ventricular Assist2017-06-06

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