Cardiovascular devices: recent FDA 510(k) clearances
52 cardiovascular devices: recent FDA 510(k) clearances are listed from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23; the most frequent is Kossel Medtech (Suzhou) Co., Ltd. with 2. Data last updated 2026-11-03; each record links to its official source and a full report.
Data as of · Compiled by Zalwin from U.S. FDA openFDA
Includes: Record, Specialty, Date, Review days, Recall class, official source URL and score · Card, Apple Pay, Google Pay or Link via Stripe
52 records from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23. Most frequent: Kossel Medtech (Suzhou) Co., Ltd. (2). Each record links to a full report and the official source.
Last updated 2026-11-03. Source: U.S. FDA openFDA.
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- Kossel Medtech (Suzhou) Co., Ltd. (2)
- Zylox Medtech Co., Ltd. (2)
- Route 92 Medical, Inc. (2)
- Sorin Group Italia S.R.L. (2)
- Aventusoft, LLC (1)
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What are the top cardiovascular devices: recent FDA 510(k) clearances right now?
Browse 35 more matching record reports
- Aristotle 65 Macrowire (K254181): 510(k) cleared for Scientia Vascular
- NC PTA Balloon Dilatation Catheter (K254212): 510(k) cleared for Kossel Medtech (Suzhou) Co., Ltd.
- Extroducer Infusion Catheter System (K254051): 510(k) cleared for SmartWise Sweden AB
- Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Reco
- Kinetic Software Library (K260640): 510(k) cleared for Monebo Technologies, Inc.
- Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter (K260686): 510(k) cleared for Zylox Medtech Co., Ltd.
- Sensinel Cardiopulmonary Management (CPM) System (K260801): 510(k) cleared for Analog Devices
- Radius VSM and Accessories (K260676): 510(k) cleared for Masimo Corporation
- Ninenovo Blood Oxygen Ring (BORMB-01-6,BORMB-01-7,BORMB-01-8,BORMB-01-9,BORMB-01-10,BORMB-01-11,BORMB-01-12,BORMB-01-13,BORMB-01-14) (K260490): 510(k) cleared for Shenzhen Ninenovo Technology Limited
- Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C, BP-202 BP-205, BP-205B,BP-206) (K260470): 510(k) cleared for Shenzhen Brav Electronic Technologies Co., Ltd.
- SmartRead(TM) Medical Device Identifier (4100) (DEN260007): 510(k) cleared for BridgeSource Medical Corporation
- ZYLOX Hippo PTA Balloon Dilatation Catheter (K260416): 510(k) cleared for Zylox Medtech Co., Ltd.
- STAR Apollo Mapping System (K263380): 510(k) cleared for Rhythm AI, Ltd.
- Toro 71 Aspiration Catheter; Toro Aspiration Tubing (K262021): 510(k) cleared for Toro Neurovascular, Inc.
- Route 92 Medical Full Length 046 Access System (K260220): 510(k) cleared for Route 92 Medical, Inc.
- Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit (K261089): 510(k) cleared for Maduro Medical, Inc.
- Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set (K263266): 510(k) cleared for Route 92 Medical, Inc.
- Intra-Operative Positioning System (IOPS) and IOPS Visionary System (K263016): 510(k) cleared for Centerline Biomedical
- Dual Stage Venous Cannulae (K263092): 510(k) cleared for Sorin Group Italia S.R.L.
- Reprocessed BRK Transseptal Needle (K262917): 510(k) cleared for Innovative Health, LLC
- Giranel Guiding Sheath Set (K262674): 510(k) cleared for Kossel Medtech (Suzhou) Co., Ltd.
- The Circadia CX00 System (CX00) (K262447): 510(k) cleared for Circadia Health, Inc.
- INDIGO® Aspiration System (K262904): 510(k) cleared for Penumbra, Inc.
- Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG) (K262068): 510(k) cleared for CathRx, Ltd.
- Excelsior Reach Microcatheter (K261649): 510(k) cleared for Stryker Neurovascular
- LOBO Vascular Occlusion System (K262798): 510(k) cleared for Okami Medical, Inc.
- MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12); MEDRAD® Imaging Bulk Package Transfer Spike (K262043): 510(k) cleared for Bayer Medical Care, Inc.
- APRO 88 Catheter (K261938): 510(k) cleared for Alembic, LLC
- Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where x may be any numeric character). (K261469): 510(k) cleared for Barco N.V.
- Elucid FFR-IQ (B.1) (K262015): 510(k) cleared for Elucid Bioimaging, Inc.
- Tri Stage Venous Cannulae (K262052): 510(k) cleared for Sorin Group Italia S.R.L.
- CrossFAST Integrated Microcatheter Advanced Delivery System (K262817): 510(k) cleared for Vantis Vascular, Inc.
- EnSite X EP System (K261729): 510(k) cleared for Abbott Medical
- JADE SCORE PTA Scoring Balloon Dilatation Catheter (K261778): 510(k) cleared for OrbusNeich Medical (Shenzhen) Co., Ltd.
- HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) (K261438): 510(k) cleared for Eurosets S.R.L
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510(k) clearances (414) Class II device recalls (320) Class I device recalls (19) Class III device recalls (11)
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Radiology (56) Orthopedic (53) Cardiovascular (52) General & Plastic Surgery (44) Dental (32) Gastroenterology & Urology (27) Neurology (23) Microbiology (21) Clinical Chemistry (15) General Hospital (14) Anesthesiology (12) Obstetrics & Gynecology (9) Ophthalmic (7)
Browse by record type by specialty
Radiology devices: recent FDA 510(k) clearances (56) Orthopedic devices: recent FDA 510(k) clearances (53) General & Plastic Surgery devices: recent FDA 510(k) clearances (44) Dental devices: recent FDA 510(k) clearances (32) Gastroenterology & Urology devices: recent FDA 510(k) clearances (27) Neurology devices: recent FDA 510(k) clearances (23) Microbiology devices: recent FDA 510(k) clearances (21) Clinical Chemistry devices: recent FDA 510(k) clearances (15) General Hospital devices: recent FDA 510(k) clearances (14) Anesthesiology devices: recent FDA 510(k) clearances (12) Obstetrics & Gynecology devices: recent FDA 510(k) clearances (9) Ophthalmic devices: recent FDA 510(k) clearances (7)
Frequently asked questions
How many cardiovascular devices: recent FDA 510(k) clearances are listed?
52 records from U.S. FDA openFDA, last refreshed automatically. The most recent is dated 2026-10-23.
Can I get alerts for Cardiovascular devices: recent FDA 510(k) clearances?
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Source: U.S. FDA openFDA. Informational only. RSS feed of new records
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