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
9577–9600 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 03, 1999
PRESSUREWIRE SENSOR, MODEL #12001
K983506 · DQX
Radi Medical Systems AB
Cardiovascular · 119d
Cleared Feb 02, 1999
EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA
K980631 · DXC
Embol-X, Inc.
Cardiovascular · 349d
Cleared Feb 02, 1999
EWC: ECG II CABLE LEADWIRE SYSTEM
K984263 · DSA
Ewc
Cardiovascular · 64d
Cleared Feb 02, 1999
MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE
K990266 · LOS
Micromedical Industries, Ltd.
Cardiovascular · 5d
Cleared Feb 01, 1999
POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER
K982385 · KRJ
Porous Media Corp.
Cardiovascular · 207d
Cleared Feb 01, 1999
GUIDEWIRE
K982559 · DQX
Galt Medical Corp.
Cardiovascular · 193d
Cleared Feb 01, 1999
PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452
K984182 · DSY
Possis Medical, Inc.
Cardiovascular · 70d
Cleared Feb 01, 1999
PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451
K984183 · DYF
Possis Medical, Inc.
Cardiovascular · 70d
Cleared Jan 29, 1999
VENOMETER
K983900 · JOM
Advanced Medical Technology , Ltd.
Cardiovascular · 87d
Cleared Jan 29, 1999
HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K
K990125 · DSI
Hewlett-Packard GmbH
Cardiovascular · 16d
Cleared Jan 27, 1999
AURORA
K972065 · DQY
Neurovena Corp.
Cardiovascular · 603d
Cleared Jan 27, 1999
GT LEGGIERO
K981359 · DQY
Terumo Medical Corp.
Cardiovascular · 288d
Cleared Jan 27, 1999
MERCATOR
K982384 · DSH
Harley Street Software , Ltd.
Cardiovascular · 203d
Cleared Jan 27, 1999
MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER MODELS, 7005, 7006, 7007,...
K982540 · MTD
Cardiac Pathways Corp.
Cardiovascular · 190d
Cleared Jan 26, 1999
PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM
K982090 · DXH
Paceart, Inc.
Cardiovascular · 225d
Cleared Jan 26, 1999
PINNACLE R/O OR REDIFOCUS INTRODUCER R/O (COMPRISED OF A SHEATH & DILATOR)
K984260 · DYB
Terumo Medical Corp.
Cardiovascular · 62d
Cleared Jan 25, 1999
FIRSTSAVE BIPHASIC MODELS 9200 AND 9210
K982264 · MKJ
Survivalink Corp.
Cardiovascular · 210d
Cleared Jan 22, 1999
6004 NIBP MONITOR WITH TEMPERATURE
K983796 · DXN
Bci Intl., Inc.
Cardiovascular · 87d
Cleared Jan 21, 1999
MCAS (MODULAR CLIP APPLIER SYSTEM)
K983744 · DSS
Applied Medical Resources
Cardiovascular · 90d
Cleared Jan 15, 1999
BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES
K983689 · DRX
Medicotest A/S
Cardiovascular · 87d
Cleared Jan 14, 1999
FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25
K982228 · DXH
Tz Medical, Inc.
Cardiovascular · 203d
Cleared Jan 13, 1999
HEART-LIFT BALLOON POSITIONER
K982419 · MWS
Cardiothoracic Systems, Inc.
Cardiovascular · 184d
Cleared Jan 11, 1999
COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K984456 · DTN
Cobe Cardiovascular, Inc.
Cardiovascular · 27d
Cleared Jan 08, 1999
LIDCO SYSTEM
K962918 · DXG
Lidco, Ltd.
Cardiovascular · 925d