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HeartSine Technologies Ltd

6 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PA recall (Z-0288-2026)HeartSine Technologies Ltd2025-10-23
HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan PAD recall (Z-2174-2025)HeartSine Technologies Ltd2025-07-25
HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P recall (Z-1820-2024)HeartSine Technologies Ltd2024-05-14
HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US- recall (Z-1141-2024)HeartSine Technologies Ltd2024-02-15
HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with th recall (Z-2143-2023)HeartSine Technologies Ltd2023-07-13
Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic d recall (Z-1217-2023)HeartSine Technologies Ltd2023-03-03

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