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Berlin Heart, Inc.

52 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
EXCOR Pediatric Ventricular Assist Device (P160035/S055)Berlin Heart, Inc.2025-12-19
EXCOR Cannula Clip (P160035/S049)Berlin Heart, Inc.2025-09-12
EXCOR Pediatric Ventricular Assist Device (P160035/S052)Berlin Heart, Inc.2025-07-24
EXCOR Pediatric Ventricular Assist Device (P160035/S051)Berlin Heart, Inc.2025-07-18
EXCOR Connecting and Extension Sets (P160035/S050)Berlin Heart, Inc.2025-05-06
EXCOR® Apex Cannulae (P160035/S048)Berlin Heart, Inc.2025-03-11
EXCOR Pediatric Ventricular Assist Device (P160035/S045)Berlin Heart, Inc.2024-12-19
EXCOR® Pediatric Ventricular Assist Device (P160035/S047)Berlin Heart, Inc.2024-11-20
EXCOR Pediatric Ventricular Assist Device (P160035/S046)Berlin Heart, Inc.2024-08-15
EXCOR Pediatric Ventricular Assist Device (P160035/S044)Berlin Heart, Inc.2024-07-02
EXCOR® Pediatric Ventricular Assist Device (P160035/S043)Berlin Heart, Inc.2024-06-05
Berlin Heart EXCOR Pediatric Ventricular Assist Device (P160035/S039)Berlin Heart, Inc.2024-04-18
EXCOR® Pediatric Ventricular Assist Device (P160035/S041)Berlin Heart, Inc.2024-02-14
EXCOR Pediatric Ventricular Assist Device (P160035/S038)Berlin Heart, Inc.2023-12-14
EXCOR® Pediatric Ventricular Assist Device (P160035/S037)Berlin Heart, Inc.2023-10-11
EXCOR Pediatric Ventricular Assist Device (P160035/S036)Berlin Heart, Inc.2023-10-05
EXCOR Blood pump (P160035/S035)Berlin Heart, Inc.2023-08-22
EXCOR® Pediatric Ventricular Assist Device (P160035/S034)Berlin Heart, Inc.2023-08-10
EXCOR Pediatric Ventricular Assist Device (P160035/S025)Berlin Heart, Inc.2023-08-10
EXCOR® Pediatric Ventricular Assist Device (P160035/S033)Berlin Heart, Inc.2023-06-30
EXCOR® Pediatric Ventricular Assist Device (P160035/S032)Berlin Heart, Inc.2023-02-17
EXCOR Pediatric Ventricular Assist Device (P160035/S030)Berlin Heart, Inc.2022-08-30
EXCOR Pediatric Ventricular Assist Device (P160035/S031)Berlin Heart, Inc.2022-08-24
EXCOR Pediatric Ventricular Assist Device (P160035/S028)Berlin Heart, Inc.2022-08-12
EXCOR® Pediatric Ventricular Assist Device (P160035/S027)Berlin Heart, Inc.2022-08-04
EXCOR Pediatric Ventricular Assist Device (P160035/S026)Berlin Heart, Inc.2022-06-15
EXCOR® Pediatric Ventricular Assist Device (P160035/S024)Berlin Heart, Inc.2022-03-04
EXCOR® Pediatric Ventricular Assist Device (P160035/S023)Berlin Heart, Inc.2021-11-18
EXCOR® Pediatric Ventricular Assist Device (P160035/S022)Berlin Heart, Inc.2021-11-02
EXCOR Pediatric Ventricular Assist Device (P160035/S021)Berlin Heart, Inc.2021-10-20
EXCOR Pediatric Ventricular Assist Device (P160035/S020)Berlin Heart, Inc.2021-10-14
EXCOR Pediatric Ventricular Assist Device (P160035/S016)Berlin Heart, Inc.2021-02-17
EXCOR Pediatric Ventricular Assist Device (P160035/S019)Berlin Heart, Inc.2021-01-13
EXCOR Pediatric Ventricular Assist Device (P160035/S018)Berlin Heart, Inc.2020-10-27
EXCOR Pediatric Ventricular Assist Device (P160035/S017)Berlin Heart, Inc.2020-10-23
Excor Pediatric Ventricular Assist Device (P160035/S013)Berlin Heart, Inc.2020-09-23
EXCOR Pediatric Ventricular Assist Device (P160035/S015)Berlin Heart, Inc.2020-09-03
EXCOR blood pumps with Injection Molded Housing (P160035/S014)Berlin Heart, Inc.2020-05-06
EXCOR Pediatric Ventricular Assist Device (P160035/S006)Berlin Heart, Inc.2020-03-13
EXCOR IKUS Driver (P160035/S008)Berlin Heart, Inc.2020-02-20
EXCOR Pediatric Ventricular Assist Device (P160035/S010)Berlin Heart, Inc.2019-12-20
Excor Pediatric Ventricular Assist Device (P160035/S011)Berlin Heart, Inc.2019-11-03
Excor Pediatric Ventricular Assist Device (P160035/S012)Berlin Heart, Inc.2019-11-03
EXCOR Pediatric Ventricular Assist Device (P160035/S009)Berlin Heart, Inc.2019-10-23
EXCOR Pediatric Ventricular Assist Device (P160035/S007)Berlin Heart, Inc.2019-09-18
EXCOR Pediatric Ventricular Assist Device (P160035/S005)Berlin Heart, Inc.2019-08-05
EXCOR Pediatric Ventricular Assist Device (P160035/S004)Berlin Heart, Inc.2018-10-26
EXCOR Pediatric Ventricular Assist Device (P160035/S001)Berlin Heart, Inc.2018-05-21
EXCOR Blood Pump (P160035/S003)Berlin Heart, Inc.2018-01-31
EXCOR Pediatric Ventricular Assist Device (P160035/S002)Berlin Heart, Inc.2017-08-02
EXCOR Pediatric Ventricular Assist Device (P160035)Berlin Heart, Inc.2017-06-06

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Every clearance here is in the API, with alerts when new ones post.