FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×

18,110 results

7465–7488 of 18,110

Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular

Cleared Nov 10, 2004

OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-906

Omron Healthcare, Inc.

Cardiovascular · 8d

Cleared Nov 08, 2004

SUBMARINE PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL...

Invatec Innovative Technologies

Cardiovascular · 49d

Cleared Nov 08, 2004

SAILOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL...

Invatec Innovative Technologies

Cardiovascular · 49d

Cleared Nov 05, 2004

T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303

Spectros Corporation

Cardiovascular · 234d

Cleared Nov 05, 2004

POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM

Cryo Vascular Systems, Inc.

Cardiovascular · 80d

Cleared Nov 05, 2004

ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX)

Possis Medical, Inc.

Cardiovascular · 18d

Cleared Nov 04, 2004

INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE...

Irvine Biomedical, Inc.

Cardiovascular · 29d

Cleared Nov 03, 2004

AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR)

Ge Medical Systems Information...

Cardiovascular · 37d

Cleared Oct 28, 2004

Cardiovascular · 132d

Cleared Oct 28, 2004

RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE

Radiant Medical

Cardiovascular · 56d

Cleared Oct 26, 2004

ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH...

Zoll Medical Corp

Cardiovascular · 62d

Cleared Oct 26, 2004

ACUMEN SHEATH, MODEL TTW7807

Acumen Medical, Inc.

Cardiovascular · 55d

Cleared Oct 26, 2004

H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168H, HL168J &...

Health & Life Co., Ltd.

Cardiovascular · 18d

Cleared Oct 22, 2004

VASOSTASIS VASCULAR CLOSURE SYSTEM

Cardiva Medical, Inc.

Cardiovascular · 140d

Cleared Oct 22, 2004

QRS-CARD CARDIOLOGY SUITE

Pulse Biomedical, Inc.

Cardiovascular · 14d

Cleared Oct 20, 2004

SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER

Ela Medical, Inc.

Cardiovascular · 86d

Cleared Oct 20, 2004

ERA 3000 PACING SYSTEM ANALYZER

Biotronik, Inc.

Cardiovascular · 20d

Cleared Oct 15, 2004

INTRAVASCULAR ACCESS INTRODUCER SHEATH

Applied Medical Resources Corp.

Cardiovascular · 130d

Cleared Oct 15, 2004

SILICONE COATED GUIDEWIRE

Arrow International, Inc.

Cardiovascular · 109d

Cleared Oct 15, 2004

INTEGRATED PATIENT MONITORING SYSTEM

Invivo Research, Inc.

Cardiovascular · 91d

Cleared Oct 15, 2004

3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000

Cardiovascular · 88d

Cleared Oct 15, 2004

ENSITE SYSTEM, MODEL EE3000

Endocardial Solutions, Inc.

Cardiovascular · 31d

Cleared Oct 15, 2004

EXCELSIOR 1018 AND SL-10 MICROCATHETERS

Boston Scientific Corp

Cardiovascular · 24d

Cleared Oct 15, 2004

ACUSON ACUNAV 8F ULTRASOUND CATHETER

Siemens Medical Solutions USA, Inc.

Cardiovascular · 22d