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
12001–12024 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 16, 1991
MODEL #100 SHOCK-TRODE CHILD DEFIB PADS
K911455 · LDD
Cardiotronics, Inc.
Cardiovascular · 196d
Cleared Oct 16, 1991
MODEL #110 STEALTH-TRODE CHILD DEFIB PADS
K911456 · LDD
Cardiotronics, Inc.
Cardiovascular · 196d
Cleared Oct 16, 1991
IVT GUIDING CATHETER
K911869 · DQY
Intensive Technology, Inc.
Cardiovascular · 173d
Cleared Oct 16, 1991
MODEL #911 STEALTH MULTI PADS
K912621 · LDD
Cardiotronics, Inc.
Cardiovascular · 125d
Cleared Oct 16, 1991
MODEL 100 CENTRAL STATION
K913193 · DQK
Protocol Systems, Inc.
Cardiovascular · 90d
Cleared Oct 16, 1991
WRISTRECORDER CARDIAC EVENT RECORDING SYSTEM
K913600 · DSH
Ralin Laboratories, Inc.
Cardiovascular · 64d
Cleared Oct 16, 1991
SUB-4(TM), PERIPHERAL DILATATION CATHETER
K913689 · LIT
Boston Scientific Corp
Cardiovascular · 58d
Cleared Oct 16, 1991
CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL
K913801 · DYB
Cordis Corp.
Cardiovascular · 51d
Cleared Oct 15, 1991
SATURATION/HEMATOCRIT MONITOR SYSTEM
K910421 · DRY
Medtronic Vascular
Cardiovascular · 258d
Cleared Oct 15, 1991
DATASCOPE PASSPORT MONITOR
K911598 · DRT
Datascope Corp.
Cardiovascular · 189d
Cleared Oct 11, 1991
GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM
K912107 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 151d
Cleared Oct 10, 1991
BIO-SENSOR 01 EKG ELECTRODE
K911472 · DRX
Bio-Sensor, Inc.
Cardiovascular · 190d
Cleared Oct 10, 1991
MARQUETTE PEDIATRIC DEFIBRILLATION/PACING PADS
K911662 · LDD
Marquette Electronics, Inc.
Cardiovascular · 181d
Cleared Oct 10, 1991
VER-MED A10020 RESTING EKG ELECTRODE
K911687 · DRX
Vermont Medical, Inc.
Cardiovascular · 177d
Cleared Oct 10, 1991
PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIED
K913110 · DRQ
Microwave Medical Systems, Inc.
Cardiovascular · 90d
Cleared Oct 10, 1991
VITALMAX 830 SERIES
K913263 · MHX
Pace Tech, Inc.
Cardiovascular · 79d
Cleared Oct 10, 1991
SCHNEIDER MATCH-35(TM) PERCU TRANS ANGIOPLAS CATH
K913297 · LIT
Schneider Intl., Ltd.
Cardiovascular · 78d
Cleared Oct 09, 1991
PEI PLAQUE ELECTRODE ARRAY
K904747 · DRF
Prucka Engineering, Inc.
Cardiovascular · 355d
Cleared Oct 09, 1991
TRU-VIEW MULTI-CHANNEL DISPLAY
K912008 · DRT
General Devices
Cardiovascular · 156d
Cleared Oct 09, 1991
NOVOSTE VESSEL DILATER
K912050 · DRE
Novaste Corp.
Cardiovascular · 153d
Cleared Oct 08, 1991
ACS VSW GUIDE WIRE
K913178 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 83d
Cleared Oct 04, 1991
SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION
K913038 · DSH
Spacelabs, Inc.
Cardiovascular · 87d
Cleared Oct 04, 1991
THORACIC CATHETER STYLET
K913543 · DRB
Intl. Medical Devices , Ltd.
Cardiovascular · 56d
Cleared Oct 03, 1991
MODEL #350 SHOCK-PLATE DEFIB ADAPTOR
K911402 · LDD
Cardiotronics, Inc.
Cardiovascular · 188d