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
14257–14280 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 12, 1986
CARDIAN II CR45A
K861621 · DRT
Cardiac Recorders, Ltd.
Cardiovascular · 136d
Cleared Sep 12, 1986
STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULE
K862836 · DXS
Shiley, Inc.
Cardiovascular · 49d
Cleared Sep 11, 1986
ACS HI-TORQUE FLEX-T GUIDE WIRE
K862360 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 80d
Cleared Sep 11, 1986
MODEL 6615 FLOSCAN DOPPLER DIAGNOSTIC CATHETER
K862673 · DQO
Medtronic Vascular
Cardiovascular · 59d
Cleared Sep 05, 1986
MODEL 617D
K863303 · LDD
Quinton, Inc.
Cardiovascular · 11d
Cleared Sep 04, 1986
ACS WIRE SHAPER
K862567 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 59d
Cleared Sep 04, 1986
INTERFACE ARTERIAL BLOOD FILTER, MODEL 42
K862591 · DTM
Medical, Inc.
Cardiovascular · 59d
Cleared Sep 04, 1986
INTERFACE ARTERIAL BLOOD FILTER, MODEL 44
K862609 · DTM
Medical, Inc.
Cardiovascular · 58d
Cleared Sep 04, 1986
ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN.
K862974 · DXY
Medtronic Vascular
Cardiovascular · 29d
Cleared Sep 03, 1986
MECHANICAL INFLATION DEVICE
K862547 · DXT
American Edwards Laboratories
Cardiovascular · 62d
Cleared Sep 02, 1986
HA-2 HUMAN BODY COMPOSITION ANALYZER
K860749 · DSB
Dj Medical Instrument Corp. C/O...
Cardiovascular · 187d
Cleared Sep 02, 1986
OLBERT CATHETER SYSTEM WITH SIDEWINDER CURVE
K862550 · LIT
Meadox Surgimed, Inc.
Cardiovascular · 61d
Cleared Aug 29, 1986
DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR
K862119 · DYG
Parke-Davis Co.
Cardiovascular · 87d
Cleared Aug 29, 1986
SCHNEIDER-SHILEY FLUSHING CATHETER
K862466 · DQO
Shiley, Inc.
Cardiovascular · 60d
Cleared Aug 29, 1986
LEFT VENTRICULAR VENT VALVE MODEL NO. GLV
K862540 · DWD
Gish Biomedical, Inc.
Cardiovascular · 58d
Cleared Aug 28, 1986
CERYX PACEMAKER MODELS 114, 314 & 614
K854790 · DXY
Vitatron Medical BV
Cardiovascular · 272d
Cleared Aug 28, 1986
OSCOR MEDICAL FIX SCREW PACING LEAD/PEELABLE CATH
K861493 · DTB
Oscor Medical Corp.
Cardiovascular · 128d
Cleared Aug 28, 1986
BURDICK DIVISION (E-500)
K861850 · DPS
Mortara Instrument, Inc.
Cardiovascular · 106d
Cleared Aug 28, 1986
SIEMENS-ELEMA (SICARD-P)
K861851 · DPS
Mortara Instrument, Inc.
Cardiovascular · 106d
Cleared Aug 28, 1986
SCHNEIDER-SHILEY Y-CONNECTOR WITH ROTATOR
K862464 · DQO
Shiley, Inc.
Cardiovascular · 59d
Cleared Aug 25, 1986
OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 915
K860488 · DXN
Cas Medical Systems, Inc.
Cardiovascular · 196d
Cleared Aug 25, 1986
CIRCADIAN STRESS TEST SYSTEM
K860973 · DPS
Circadian, Inc.
Cardiovascular · 164d
Cleared Aug 25, 1986
MODEL FB-20 NON-INVASIVE BLOOD PRESSURE MONITOR
K861504 · DXN
Fukuda Denshi USA, Inc.
Cardiovascular · 124d
Cleared Aug 25, 1986
ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR
K861981 · DRW
Vital Signs, Inc.
Cardiovascular · 95d