Berlin Heart G M B H

FDA Filings

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

FDA Registration(s)

• Registration Number: 3004582654
• FEI Number: 3004582654
• Name: BERLIN HEART GMBH
• Owner & Operator: Berlin Heart GmbH
• Contact Address: Weisenweg 10 Steglitz; Berlin DE-BE Berlin D-12247 DE
• US Agent:
  • Robert Kroslowitz
  • Berlin Heart, Inc.
  • 281 8639700
  • 281 8639701
  • rkroslowitz@berlinheartinc.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Wiesenweg 10 Steglitz; Berlin Berlin, D-12247 DE
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 04260090041369 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090041352 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090041338 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090041321 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090041307 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090041291 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090041284 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090041277 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040607 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040591 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040577 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040560 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040553 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040539 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040515 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040508 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040492 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040461 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040430 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040423 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040393 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040386 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040379 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040348 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040331 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040287 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040256 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040249 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040232 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040225 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040188 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040171 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040164 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040157 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040140 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040126 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040119 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040102 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040027 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090040010 Berlin Heart GmbH	EXCOR® VAD	2020-02-20
GUDID 04260090041086 Berlin Heart GmbH	EXCOR® VAD	2018-07-06
GUDID 04260090041055 Berlin Heart GmbH	EXCOR® VAD	2018-07-06
GUDID 04260090040409 Berlin Heart GmbH	EXCOR® VAD	2018-07-06
PMN P160035 | DSQ BERLIN HEART GMBH	EXCOR? Pediatric Ventricular Assist Device	2017-08-09
PMN H100004 | PCK BERLIN HEART GMBH	EXCOR Pediatric Ventricular Assist Device	2012-03-02

Similar & Related FDA Registered Companies

• Berlin Heart Inc.9391 Grogan's Mill Road, Suite A-6the Woodlands, TX 77380 PMA NumberP160035 Supplement NumberS031 Date Received08/02/2022 Decision Date08/24/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Berlin Heart Inc.9391 Grogan's Mill Road, Suite A-6the Woodlands, TX 77380 PMA NumberP160035 Supplement NumberS028 Date Received07/15/2022 Decision Date08/12/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Berlin Heart Inc.9391 Grogan's Mill Road, Suite A-6the Woodlands, TX 77380 PMA NumberP160035 Supplement NumberS027 Date Received07/05/2022 Decision Date08/04/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Berlin Heart Inc.9391 Grogan's Mill Road, Suite A-6the Woodlands, TX 77380 PMA NumberP160035 Supplement NumberS026 Date Received05/16/2022 Decision Date06/15/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Berlin Heart Inc.9391 Grogan's Mill Road, Suite A-6the Woodlands, TX 77380 PMA NumberP160035 Supplement NumberS024 Date Received11/08/2021 Decision Date03/04/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No