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
15841–15864 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 12, 1983
COMMAND ULTRA II
K831216 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 89d
Cleared Jul 07, 1983
OMAR
K830915 · DSH
Oxford Medilog, Inc.
Cardiovascular · 107d
Cleared Jul 07, 1983
VITA/TRAC 4 FUNCTION VITAL SIGN MONITOR
K830916 · DRT
Bib, Inc.
Cardiovascular · 107d
Cleared Jul 07, 1983
RESTROSPECTIVE ECG MEMORY MODULE
K831406
Cardiac Evaluation Center, Inc.
Cardiovascular · 66d
Cleared Jul 07, 1983
LEATHER VALVE CUTTER
K831455 · DWS
American V. Mueller
Cardiovascular · 62d
Cleared Jun 30, 1983
CARDIOTOMY FILTER
K830634 · JOD
Texas Medical Products, Inc.
Cardiovascular · 121d
Cleared Jun 30, 1983
ARGYLE DUAL STAGE VENOUS RETURN CATH.
K831332 · DWF
Sherwood Medical Co.
Cardiovascular · 66d
Cleared Jun 30, 1983
DINAMAP VITAL SIGNS MONITOR #1846
K831515 · DXN
Critikon Company, LLC
Cardiovascular · 49d
Cleared Jun 30, 1983
MODEL TP THERMISTOR PROBE
K831528 · DRF
Scimed Life Systems, Inc.
Cardiovascular · 49d
Cleared Jun 30, 1983
CCS MODEL SJ-103 IMPLANTABLE ATRIAL
K831529 · DTB
Cardiac Control Systems, Inc.
Cardiovascular · 49d
Cleared Jun 30, 1983
SONTEK INFUSION CATHETER
K831562 · DQO
Sontek Corp.
Cardiovascular · 45d
Cleared Jun 30, 1983
CORONARY GUIDING CATHETER-MODIFIED
K831563 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 45d
Cleared Jun 30, 1983
AORTIC ROOT CANNULA W/INTEGRAL PRESS
K831591 · DWF
Dlp, Inc.
Cardiovascular · 44d
Cleared Jun 30, 1983
ACCU-FLUSH
K831637 · KRA
Accu-Line
Cardiovascular · 38d
Cleared Jun 30, 1983
CORONARY INFUSION CATHETER
K831717 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 30d
Cleared Jun 22, 1983
UNIVERSAL MEDDARS SYSTEM
K830791 · DPS
Electronics For Medicine, Inc.
Cardiovascular · 100d
Cleared Jun 22, 1983
GOULD MODEL IM3000-IM3100 BATTERY POWER
K830885 · DRT
Gould, Inc.
Cardiovascular · 93d
Cleared Jun 18, 1983
CIRCA MED TWO-CHANNEL
K830830 · DSI
Circadian, Inc.
Cardiovascular · 94d
Cleared Jun 16, 1983
VASCULAB BLOOD PRESSURE CUFF
K831393 · DXQ
Medasonics, Inc.
Cardiovascular · 48d
Cleared Jun 15, 1983
CENTRAL STATION DISPLAY/RECORDER MATRIX
K830517 · DRT
Marquette Electronics, Inc.
Cardiovascular · 118d
Cleared Jun 15, 1983
QUIK-SILVER RESTING ECG ELECTRODE
K830655 · DRX
Quinton, Inc.
Cardiovascular · 105d
Cleared Jun 15, 1983
THERMODILUTION CARDIAC OUTPUT COMPUTER-
K830892 · DXG
American Edwards Laboratories
Cardiovascular · 86d
Cleared Jun 15, 1983
COMMAND ULTRA I
K831161 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 65d
Cleared Jun 15, 1983
METAL-BACKED ACETABULAR CUP
K831479 · DXQ
Dow Corning Corp. Healthcare...
Cardiovascular · 37d