FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,110 results
9793–9816 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 07, 1998
VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT
K981079 · DSY
Impra, Inc.
Cardiovascular · 44d
Cleared May 05, 1998
OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR
K972020 · DXW
Cas Medical Systems, Inc.
Cardiovascular · 337d
Cleared May 05, 1998
JOBST ATHROMBIC PUMP SYSTEM 2600
K980456 · JOW
Jobst A Beiersdorf Co.
Cardiovascular · 89d
Cleared May 01, 1998
DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR...
K980385 · DSP
Datascope Corp.
Cardiovascular · 88d
Cleared Apr 30, 1998
MICROLIFE MANUAL BLOOD PRESSURE MONITOR (MANUAL INFLATE) MODEL BP-2BIO
K970139 · DPW
Micro Weiss Electronics
Cardiovascular · 470d
Cleared Apr 30, 1998
MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR
K970211 · DPW
Micro Weiss Electronics
Cardiovascular · 464d
Cleared Apr 30, 1998
MOOORLDI LASER DOPPLER IMAGER
K980383 · DPT
Moor Instruments, Ltd.
Cardiovascular · 87d
Cleared Apr 30, 1998
DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H
K980534 · KRH
The Heart Valve Div. Medtronic...
Cardiovascular · 78d
Cleared Apr 29, 1998
SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES
K980360 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared Apr 28, 1998
EASY ECG PC BASED ELECTROCARDIOGRAPH
K972996 · DPS
Ates Medical S.R.L.
Cardiovascular · 259d
Cleared Apr 27, 1998
CSS-CARDIOPLEGIA SAFETY SYSTEM
K973237 · DWB
Medtronic Bio-Medicus, Inc.
Cardiovascular · 242d
Cleared Apr 24, 1998
PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR...
K972793 · DQX
Radi Medical Systems AB
Cardiovascular · 270d
Cleared Apr 24, 1998
URESIL DILATOR WITH RADIOPAQUE MARKER
K980282 · DRE
Uresil Corp.
Cardiovascular · 88d
Cleared Apr 24, 1998
ACS HI-TORQUE SUPER SPORT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K980294 · DQX
Guidant Corp.
Cardiovascular · 87d
Cleared Apr 23, 1998
CS/3 ARRHYTHMIA WORKSTATION
K974747 · DSI
Datex-Engstrom, Inc.
Cardiovascular · 125d
Cleared Apr 21, 1998
FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FEMOSTOP II PUMP,...
K980898 · DXC
Radi Medical Systems AB
Cardiovascular · 43d
Cleared Apr 20, 1998
HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER
K971504 · DRF
J-Lloyd Medical, Inc.
Cardiovascular · 360d
Cleared Apr 20, 1998
ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC.
K973639 · DRF
J-Lloyd Medical, Inc.
Cardiovascular · 208d
Cleared Apr 16, 1998
PTA BALLOON CATHETER
K972800 · LIT
Cook, Inc.
Cardiovascular · 262d
Cleared Apr 14, 1998
PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE
K972201 · DXZ
Sulzer Carbomedics, Inc.
Cardiovascular · 307d
Cleared Apr 14, 1998
CH-611B AND CH-611C DIGITAL WRIST SPHYGMOMANOMETERS BLOOD PRESSURE METER
K973613 · DXN
Foley & Lardner
Cardiovascular · 204d
Cleared Apr 14, 1998
ENVOY PATIENT MONITOR
K974510 · DSI
Mennen Medical, Inc.
Cardiovascular · 134d
Cleared Apr 10, 1998
CV PERI-GUARD - CARDIOVASCULAR PATCH
K971726 · DXZ
Bio-Vascular, Inc.
Cardiovascular · 336d
Cleared Apr 10, 1998
FLOW RIDER FLOW DIRECTED MICRO CATHETER
K980104 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 88d