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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,151 results
12865–12888 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 15, 1990
ULTRAMARK 7 ULTRASOUND SYSTEM
K896543 · DXK
Advanced Technology Laboratories, Inc.
Cardiovascular · 90d
Cleared Feb 15, 1990
RMI ANTEPLEGIA CANNULA
K896636 · DWF
Research Medical, Inc.
Cardiovascular · 85d
Cleared Feb 14, 1990
SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESER. #9461
K896671 · DTZ
3M Company
Cardiovascular · 79d
Cleared Feb 13, 1990
CARDIOPULMONARY SUPPORT (CPS) SYSTEM
K892664 · DTZ
Bard Cardiosurgery Div
Cardiovascular · 306d
Cleared Feb 13, 1990
MICROPOTENTIAL ANALYZER/SPECTROCARDIOGRAPHY OPTION
K895793 · DSH
Del Mar Avionics
Cardiovascular · 138d
Cleared Feb 13, 1990
LASERFLO BLOOD PERFUSION MONITOR, MODEL BPM2
K896515 · DPW
Tsi, Inc.
Cardiovascular · 90d
Cleared Feb 12, 1990
THE SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATH.
K896597 · DSP
Boston Scientific Corp
Cardiovascular · 83d
Cleared Feb 08, 1990
MODEL 493 SSR-3 THREE CHANNEL SOLID-STATE RECORDER
K894543 · DSI
Del Mar Avionics
Cardiovascular · 203d
Cleared Feb 08, 1990
PERMANENT AND TEMP. PACEMAKER ELECTRODE & LEAD ADA
K895136 · DTB
Medtronic Vascular
Cardiovascular · 176d
Cleared Feb 08, 1990
SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME
K896466 · DYG
Baxter Healthcare Corp
Cardiovascular · 87d
Cleared Feb 07, 1990
HP SONOS 500 AND SONOS 1000 ULTRA. IMAGING SYSTEM
K896435 · DPT
Hewlett-Packard Co.
Cardiovascular · 90d
Cleared Feb 05, 1990
CIRCAMED HOLTER VERSION 4
K894956 · DPS
Circadian, Inc.
Cardiovascular · 185d
Cleared Feb 05, 1990
PERCOR STAT-DL 9.5 FR & STAT-SL 8.5 FR INTRA-AORTI
K896430 · DSP
Datascope Corp.
Cardiovascular · 89d
Cleared Feb 05, 1990
CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420
K896971 · DWC
Daily Medical Products, Inc.
Cardiovascular · 54d
Cleared Feb 05, 1990
CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520
K896972 · DWC
Daily Medical Products, Inc.
Cardiovascular · 54d
Cleared Feb 05, 1990
CARDIAC COOLING JACKET, 30% ENLARGED, MODEL CJ-320
K896973 · DWC
Daily Medical Products, Inc.
Cardiovascular · 54d
Cleared Feb 05, 1990
CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120
K896974 · DWC
Daily Medical Products, Inc.
Cardiovascular · 54d
Cleared Feb 05, 1990
CARDIAC COOLING JACKET, 30% REDUCED, MODEL CJ-220
K896975 · DWC
Daily Medical Products, Inc.
Cardiovascular · 54d
Cleared Feb 05, 1990
MODIFIED J-STIFFENER WIRE MATERIAL IN LEAD LINES
K897067 · DTB
Telectronics Pacing Systems, Inc.
Cardiovascular · 46d
Cleared Feb 02, 1990
ACS GOLD SERIES ELASTINITE GUIDE WIRE
K896379 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 88d
Cleared Feb 02, 1990
CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620
K896393 · DWC
Daily Medical, Inc.
Cardiovascular · 88d
Cleared Feb 01, 1990
HEMOLASER HEMOSCOPE
K893816 · LYK
Hemolaser Corp.
Cardiovascular · 254d
Cleared Feb 01, 1990
AUTO-CUFF(TM)
K896633 · DXN
U.S. Medical Corp.
Cardiovascular · 71d
Cleared Feb 01, 1990
FUKUDA DENSHI MODEL DS-3300 ETR
K897063 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 43d