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
10033–10056 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 18, 1997
DINAMAP COMPACT MONITOR
K970182 · MHX
Johnson & Johnson Medical, Inc.
Cardiovascular · 213d
Cleared Aug 15, 1997
PRINTER INTERFACE
K970305 · DXH
Micromedical, Inc.
Cardiovascular · 200d
Cleared Aug 15, 1997
SIEMENS SC/9000/SC9015 SERIES SURGICAL DISPLAY CONTROLLER
K970348 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 198d
Cleared Aug 14, 1997
HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET
K963073 · LDF
Harmac Medical Products, Inc.
Cardiovascular · 412d
Cleared Aug 14, 1997
HARMAC THERMODILUTION CATHETER
K963336 · DYG
Harmac Medical Products, Inc.
Cardiovascular · 412d
Not Cleared Aug 14, 1997
A1-A,ABP,B,MBP, LEAD CONNECTORS
K970388 · DTD
Biotronik, Inc.
Cardiovascular · 192d
Cleared Aug 14, 1997
THE CIRCULATOR BOOT
K971026 · DRN
Circulator Boot Corp.
Cardiovascular · 147d
Not Cleared Aug 14, 1997
BK-N SEALING CAP
K971930 · DTD
Biotronik, Inc.
Cardiovascular · 79d
Cleared Aug 14, 1997
Cordis Endeavor Infusion Catheter
K972110 · QEY
Cordis Corp.
Cardiovascular · 70d
Cleared Aug 13, 1997
SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431)
K964784 · DPS
Quinton, Inc.
Cardiovascular · 259d
Cleared Aug 12, 1997
ECG REVIEW STATION
K942685 · DXJ
Mortara Instrument, Inc.
Cardiovascular · 1162d
Cleared Aug 12, 1997
CHASE PHRENIC NERVE PAD
K971021 · DWF
Chase Medical, Inc.
Cardiovascular · 145d
Cleared Aug 11, 1997
ARRHYTHMIA MAPPING SYSTEM (8100/8300)
K965066 · DRF
Cardiac Pathways Corp.
Cardiovascular · 236d
Cleared Aug 08, 1997
THROMBOLYTIC BRUSH CATHETER
K963925 · MCW
Micro Therapeutics, Inc.
Cardiovascular · 312d
Cleared Aug 08, 1997
VISION CARDIOPLEGIA DELIVERY SYSTEM
K964571 · DTR
Lifestream Int'L, Inc.
Cardiovascular · 267d
Cleared Aug 08, 1997
FAVC-M: FEMORAL ARTERY VASCULAR CLAMP-MOBILE (MODEL M100-M200) FAVC-M FEMORAL...
K970027 · DXC
Rmds, Inc.
Cardiovascular · 217d
Cleared Aug 06, 1997
TRINITY SLEEVES, HUNTLEIGH PUMP COMPATIBLE(T.B.D.)
K970014 · JOW
Delphi Consulting Group
Cardiovascular · 216d
Cleared Aug 05, 1997
AFFINITY BLOOD PUMP SYSTEM
K964017 · DTQ
Avecor Cardiovascular, Inc.
Cardiovascular · 302d
Cleared Aug 05, 1997
40 CC SUMO
K971673 · DSP
Boston Scientific Corp
Cardiovascular · 90d
Cleared Aug 01, 1997
MEDI-DYNE GUIDING CATHETER
K970401 · DQY
Medi-Dyne, Inc.
Cardiovascular · 179d
Cleared Jul 31, 1997
MEDI-TECH 5 FRENCH NIGHTHAWK SELECTIVE ANGIOGRAPHIC CATHETERS
K970207 · DQO
Boston Scientific Corp
Cardiovascular · 191d
Cleared Jul 31, 1997
EVT EXPANDABLE SHEATH
K970470 · DRE
Guidant Cardiac and Vascular Surgery
Cardiovascular · 174d
Cleared Jul 29, 1997
SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
K970920 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 139d
Cleared Jul 28, 1997
FIRST MEDIC PULSE OXIMETRY MODULE
K955890 · MKJ
Colorado Medtech, Inc.
Cardiovascular · 577d