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
14497–14520 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 17, 1986
BIOMECCA CENTRAL CS1
K854639 · DRT
Biomecca Australia , Ltd.
Cardiovascular · 149d
Cleared Apr 17, 1986
CARDIOFAX ECG-6353
K860212 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 85d
Cleared Apr 16, 1986
ANGIOMED GUIED WIRES
K854912 · DQX
Angiomed U.S., Inc.
Cardiovascular · 128d
Cleared Apr 16, 1986
PMS PERCUTANEOUS PUNCTURE NEEDLE
K854941 · DYB
Professional Medical Services
Cardiovascular · 127d
Cleared Apr 16, 1986
CURITY PERCUTANEOUS CATHETER INSERTION TRAY
K855060 · DYB
The Kendal Co.
Cardiovascular · 119d
Cleared Apr 16, 1986
CURITY PERCUTANEOUS CATHETER INSERTION KIT
K855061 · DYB
The Kendal Co.
Cardiovascular · 119d
Cleared Apr 15, 1986
CD-200 CARDIAC MONITOR
K860175 · DPS
Cardio Display Corp.
Cardiovascular · 88d
Cleared Apr 14, 1986
BOMED-CDM
K853706 · DSB
Bomed Medical Mfr., Ltd.
Cardiovascular · 222d
Cleared Apr 14, 1986
ULTRASONIC COUPLANT GEL
K854996 · JOP
Johnson & Johnson Professionals, Inc.
Cardiovascular · 123d
Cleared Apr 11, 1986
ECG-ELECTRODE(SWAROMED)
K853939 · DRX
D. Swarovski & Co.
Cardiovascular · 199d
Cleared Apr 11, 1986
MODEL 509A PHYSIOCORDER AMBULATORY RECORDER
K854269 · DSH
Del Mar Avionics
Cardiovascular · 170d
Cleared Apr 09, 1986
LONG TERM RECORDER RAG 1200
K854866 · DSF
Nihon Kohden America, Inc.
Cardiovascular · 152d
Cleared Apr 02, 1986
STABLELINE
K860298 · KRI
Cardio Metrics, Inc.
Cardiovascular · 64d
Cleared Apr 02, 1986
RIGHT ATRIAL CATHETER CATALOG NO. RAC - XXX SERIES
K860699 · DQY
Intracath, Inc.
Cardiovascular · 36d
Cleared Mar 31, 1986
UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762
K852973 · DXY
Ela Medical, Inc.
Cardiovascular · 259d
Cleared Mar 31, 1986
MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL
K853669 · DSI
Hewlett-Packard Co.
Cardiovascular · 209d
Cleared Mar 31, 1986
SCHNEIDER-SHILEY PERIPHERAL DILATATION CATHETER
K854319 · LIT
Shiley, Inc.
Cardiovascular · 154d
Cleared Mar 31, 1986
ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRES
K854830 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 118d
Cleared Mar 31, 1986
VALVOKIT
K854831 · DYB
Novamed Products, Inc.
Cardiovascular · 118d
Cleared Mar 31, 1986
CUP MONITORING KIT CVPK-14
K854984 · DQY
Medical Components, Inc.
Cardiovascular · 109d
Cleared Mar 31, 1986
NONINVASIVE TEMP. PACEMAKER NTP-1000
K855015 · DRO
Zmi Corp.
Cardiovascular · 105d
Cleared Mar 31, 1986
DEFIB-PADS
K855082 · LDD
Conmedcorp
Cardiovascular · 102d
Cleared Mar 31, 1986
FUKUDA DENSHI CARDIMAX FCP-211
K860024 · DSI
Brentwood Instruments, Inc.
Cardiovascular · 87d
Cleared Mar 31, 1986
VENOUS PERFUSION CANNULA W/CUFF CAT. NO. 94015
K860149 · DWF
Dlp, Inc.
Cardiovascular · 75d