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

7897–7920 of 18,110

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

Cleared Sep 09, 2003

SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX

Datascope Corp.

Cardiovascular · 85d

Cleared Sep 09, 2003

INFINITY MEGACARE

Siemens Medical Solutions USA, Inc.

Cardiovascular · 75d

Cleared Sep 09, 2003

BLOOD PRESSURE MONITOR, MODEL KP-7000

K-Jump Health Co., Ltd.

Cardiovascular · 28d

Cleared Sep 05, 2003

Qrs Diagnostic, LLC

Cardiovascular · 72d

Cleared Sep 05, 2003

PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601

Cardiovascular · 66d

Cleared Sep 05, 2003

PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER

Precision Vascular Systems, Inc.

Cardiovascular · 23d

Cleared Sep 05, 2003

ENCLOSE II ANASTOMOSIS ASSIST DEVICE

Novare Surgical Systems, Inc.

Cardiovascular · 14d

Cleared Sep 04, 2003

MACROPORE CARDIO-WRAP (TS)

Macropore Biosurgery, Inc.

Cardiovascular · 86d

Cleared Sep 04, 2003

ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR

Imagyn Medical Technologies, Inc.

Cardiovascular · 23d

Cleared Sep 03, 2003

EDWARDS DIRECTIONAL CATHETER

Edwards Lifesciences, LLC

Cardiovascular · 188d

Cleared Sep 03, 2003

MERIT MAK (MINI ACCESS KIT)

Merit Medical Systems, Inc.

Cardiovascular · 93d

Cleared Sep 03, 2003

ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS

Medtronic Vascular

Cardiovascular · 8d

Cleared Aug 29, 2003

POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM

Cryo Vascular Systems, Inc.

Cardiovascular · 172d

Cleared Aug 29, 2003

MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711

Medtronic Perfusion Systems

Cardiovascular · 88d

Cleared Aug 29, 2003

STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP

Stockert Instrumente GmbH

Cardiovascular · 39d

Cleared Aug 27, 2003

MOBILE BATTERY SERVICE STATION (MBSS)

Ad Elektronik GmbH

Cardiovascular · 159d

Cleared Aug 27, 2003

HEARTSTART MRX, MODEL M3535A

Philips Medical Systems

Cardiovascular · 134d

Cleared Aug 27, 2003

DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)

LeMaitre Vascular, Inc.

Cardiovascular · 57d

Cleared Aug 27, 2003

WORKHORSE II PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER

AngioDynamics, Inc.

Cardiovascular · 55d

Cleared Aug 27, 2003

Remco Italia S.P.A.

Cardiovascular · 35d

Cleared Aug 26, 2003

HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

Cardiovascular · 88d

Cleared Aug 26, 2003

GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200

Edwards Lifesciences, LLC

Cardiovascular · 35d

Cleared Aug 26, 2003

MODIFICATION TO OUTBACK CATHETER

Cardiovascular · 32d

Cleared Aug 26, 2003

ANGIODYNAMICS ACCU-VU SIZING ANGIOGRAPHIC CATHETER

AngioDynamics, Inc.

Cardiovascular · 25d