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
12025–12048 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 30, 1991
IMPEDANCE PHLEBOGRAPH/PHOTOPLETHYSMOGRAPH-DVT-2000
K911194 · DSB
Rjl Systems, Inc.
Cardiovascular · 196d
Cleared Sep 27, 1991
SAFEWEDGE(TM) RELIEF VALVE DEVICE
K912172 · KRB
Sunscope Intl., Inc.
Cardiovascular · 134d
Cleared Sep 25, 1991
SARNS NON-FILTERED VENOUS RESERVOIR
K912915 · DTP
3M Health Care, Ltd.
Cardiovascular · 84d
Cleared Sep 25, 1991
SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER
K912920 · DTZ
3M Health Care, Ltd.
Cardiovascular · 84d
Cleared Sep 23, 1991
CARDIOSWISS CM-8
K910109 · DSI
Care Systems, Inc.
Cardiovascular · 256d
Cleared Sep 23, 1991
TRAC-WRIGHT SYSTEM, MODEL TW2
K910594 · DXT
Dow Corning Wright
Cardiovascular · 223d
Cleared Sep 23, 1991
RIGHT ATRIAL CATHETERS
K911333 · DQY
Akcess Medical Products, Inc.
Cardiovascular · 181d
Cleared Sep 23, 1991
MDPHONE CELLULAR + RESCUE (DEFIB SYSTEM)
K911604 · LDD
Medphone Corp.
Cardiovascular · 166d
Cleared Sep 23, 1991
AMPLANTZ AND BENTSON GUIDEWIRES
K912798 · DQX
Meadox Medicals, Div. Boston...
Cardiovascular · 90d
Cleared Sep 23, 1991
CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAY
K912833 · DSK
Camino Laboratories, Inc.
Cardiovascular · 89d
Cleared Sep 23, 1991
PROFUSE INFUSION SYSTEM
K912877 · DQY
Lake Region Mfg., Inc.
Cardiovascular · 84d
Cleared Sep 23, 1991
LOW POROSITY (LP) VASCULAR PROSTHESIS
K912911 · DSY
Intervascular, Inc.
Cardiovascular · 83d
Cleared Sep 23, 1991
MODIFIED OSCOR PY PACING LEADS/MODIFICATION
K913158 · DTB
Oscor Medical Corp.
Cardiovascular · 77d
Cleared Sep 23, 1991
PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION
K913201 · DTB
Oscor Medical Corp.
Cardiovascular · 77d
Cleared Sep 23, 1991
IMPLANT PACING LEAD, TINED #3262, MODIFICATION
K913202 · DTB
Oscor Medical Corp.
Cardiovascular · 77d
Cleared Sep 23, 1991
IMPLANT PACING LEAD TINED #3390, MODIFICATION
K913203 · DTB
Oscor Medical Corp.
Cardiovascular · 77d
Cleared Sep 23, 1991
MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATION
K913204 · DTB
Oscor Medical Corp.
Cardiovascular · 77d
Cleared Sep 23, 1991
OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF
K913205 · DTB
Oscor Medical Corp.
Cardiovascular · 77d
Cleared Sep 23, 1991
IMPLANT PACING LEAD, RETRACTABLE, MODIFICATION
K913393 · DTB
Oscor Medical Corp.
Cardiovascular · 77d
Cleared Sep 20, 1991
GALIX MODEL MA-6R HOLTER REEL-TO-REEL RECORDER
K904176 · DSH
Galix Instrumentacion Biomedica
Cardiovascular · 374d
Cleared Sep 20, 1991
GALIX MA-6C HOLTER CASSETTE RECORDER
K904177 · DSH
Galix Instrumentacion Biomedica
Cardiovascular · 374d
Cleared Sep 20, 1991
CORDIS 7 FRENCH 0.072 I.D. PTCA GUIDING CATHETER
K912777 · DQY
Cordis Corp.
Cardiovascular · 88d
Cleared Sep 19, 1991
FURUI SHUNT, 2-WAY AND 3-WAY
K910004 · DWF
Theramed, Inc.
Cardiovascular · 260d
Cleared Sep 18, 1991
PRO-GUIDE
K911747 · DQY
American Interventional Technology
Cardiovascular · 153d