FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×

18,053 results

12505–12528 of 18,053

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

Cleared Sep 14, 1990

Heart Technology, Inc.

Cardiovascular · 184d

Cleared Sep 14, 1990

NEOS (TM) 02 B PULSE GENERATOR

Biotronik, GmbH & Co.

Cardiovascular · 64d

Cleared Sep 14, 1990

Cardiovascular · 29d

Cleared Sep 11, 1990

OXIMETRY PROBE CATHETERS

Baxter Healthcare Corp

Cardiovascular · 147d

Cleared Sep 11, 1990

PERSONAL 120/210 BASIC ELECTROCARDIOGRAPH

Esaote Biomedica Spa

Cardiovascular · 105d

Cleared Sep 07, 1990

FUKUDA DENSHI MODEL FCP-2201 MODIFICATION

Fukuda Denshi USA, Inc.

Cardiovascular · 87d

Cleared Sep 06, 1990

SMALL JOINT INSTRUMENTS (SCISSOR HANDLE)

Leonard Medical, Inc.

Cardiovascular · 30d

Cleared Sep 05, 1990

(PBS) PORTABLE BYPASS SYSTEM, MODEL 1000

Bio Medicus, Inc.

Cardiovascular · 173d

Cleared Sep 05, 1990

AXILLOBIFEMORAL GORE-TEX VASCULAR GRAFT

W.L. Gore & Associates, Inc.

Cardiovascular · 149d

Cleared Sep 04, 1990

ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND

Hitachi Medical Corp. of America

Cardiovascular · 147d

Cleared Sep 04, 1990

ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND

Hitachi Medical Corp. of America

Cardiovascular · 147d

Cleared Sep 04, 1990

SILVER MACTRODE

Marquette Electronics, Inc.

Cardiovascular · 112d

Cleared Sep 04, 1990

PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP)

Prucka Engineering, Inc.

Cardiovascular · 76d

Cleared Sep 04, 1990

ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTH

Labeltape Meditect, Inc.

Cardiovascular · 75d

Cleared Sep 04, 1990

.018 HI-TORQUE FLOPPY GUIDE WIRE W/ PRESHAPED TIP

Advanced Cardiovascular Systems, Inc.

Cardiovascular · 74d

Cleared Sep 04, 1990

COOK CORONARY GUIDING CATHETER

Cardiovascular · 64d

Cleared Sep 04, 1990

BIOCHEM 6100 NON-INVASIVE MONITOR

Biochem International, Inc.

Cardiovascular · 43d

Cleared Sep 04, 1990

MODEL 610 MODIFIED

First Medical Devices Corp.

Cardiovascular · 26d

Cleared Aug 30, 1990

CATHSCANNER(R) PTA BALLOON DILATATION CATHETER

Endosonics Corp.

Cardiovascular · 90d

Cleared Aug 24, 1990

WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL SET

Medical Engineering and Development...

Cardiovascular · 81d

Cleared Aug 23, 1990

MODELS 6207/6208/6209/6210/6211/6212/6214 (PLI'S)

Medtronic Vascular

Cardiovascular · 202d

Cleared Aug 23, 1990

INTRODUCER, PERCUTANEOUS

Novoste Puerto Rico, Inc.

Cardiovascular · 195d

Cleared Aug 23, 1990

MANAN ARTERIAL CATHETER NEEDLE

Manan Medical Products, Inc.

Cardiovascular · 174d

Cleared Aug 23, 1990

CENTRALSCOPE 12

Marquette Electronics, Inc.

Cardiovascular · 169d