FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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 · Free access · No registration required

Filters: Cardiovascular ×
18,151 results
16201–16224 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 18, 1982
BRACHIAL CORONARY GUIDING CATHETER
K822862 · DQO
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 21d
Cleared Oct 18, 1982
THERMOSTATIC WATER MIXING VALVE TWV10
K822874 · DWC
Gambro, Inc.
Cardiovascular · 21d
Cleared Oct 18, 1982
MODEL 78534A PATIENT MONITOR
K822876 · DRT
Hewlett-Packard Co.
Cardiovascular · 21d
Cleared Oct 18, 1982
MODEL 78554A DATA MGMT. PLUG-IN MODULE
K822877 · DXG
Hewlett-Packard Co.
Cardiovascular · 21d
Cleared Oct 18, 1982
MODEL 78553A PRESSURE PLUG-IN MODULE
K822878 · DSK
Hewlett-Packard Co.
Cardiovascular · 21d
Cleared Oct 15, 1982
BIPOLAR TEMP. PACING CATHETER W/STYLETET
K822002 · LDF
Ziehm International, Inc.
Cardiovascular · 99d
Cleared Oct 15, 1982
BALLOON TEMP. PACING CATHETER
K822003 · LDF
Ziehm International, Inc.
Cardiovascular · 99d
Cleared Oct 15, 1982
DIGITAL PULSE METER (73 BWS) #HRM-100E
K822692 · DRT
Sanyo Electric, Inc.
Cardiovascular · 38d
Cleared Oct 15, 1982
SIGNAL DISTRIBUTION NETWORK #78581A
K822695 · DRT
Hewlett-Packard Co.
Cardiovascular · 38d
Cleared Oct 15, 1982
SWAN-GANZ BIPOLAR PACING CATHETER
K822723 · DYG
American Edwards Laboratories
Cardiovascular · 38d
Cleared Oct 15, 1982
DISPOSABLE ELECTRODE #1900
K822798 · DRX
Andover Medical, Inc.
Cardiovascular · 29d
Cleared Oct 15, 1982
MODEL 325D UNIPOLAR CARDIAC PULSE GEN
K822904 · DXY
Cook Pacemaker Corp.
Cardiovascular · 16d
Cleared Oct 08, 1982
DEL MAR AVIONICS MODEL 551 NEUROCORDER
K822751
Del Mar Avionics
Cardiovascular · 25d
Cleared Oct 04, 1982
CARDIO TEHCHANALYZER
K821711 · DSI
Cardio Technology , Ltd.
Cardiovascular · 117d
Cleared Oct 04, 1982
COAXIAL BIPOLAR PACING ELECTRODE
K822239 · DTB
Burditt & Calkins-Siemens-Elema
Cardiovascular · 68d
Cleared Oct 04, 1982
ENERTRAX MODEL 7100E
K822297 · DXY
Medtronic Vascular
Cardiovascular · 62d
Cleared Oct 04, 1982
COMMAND NP
K822309 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 62d
Cleared Oct 04, 1982
ALTA III ECG RECORDER
K822363 · DSH
Scole Engineering Co.
Cardiovascular · 59d
Cleared Oct 04, 1982
M-MODE ANALYSIS SYSTEM
K822425 · DXK
User Resources, Inc.
Cardiovascular · 53d
Cleared Oct 04, 1982
PRESSURE ISOLATION AMPLIFIER #9813 517
K822590 · DRJ
Honeywell, Inc.
Cardiovascular · 27d
Cleared Oct 04, 1982
JAIN INSULATING BOOT MODEL 225B
K822652 · DXY
Cook Pacemaker Corp.
Cardiovascular · 32d
Cleared Oct 04, 1982
REUSABLE FOGARTY FLEXIBLE CALIBRATOR
K822687 · DWP
American Edwards Laboratories
Cardiovascular · 31d
Cleared Oct 04, 1982
SERIES 7000 BEDSIDE PATIENT MONITOR
K822718 · DSI
Marquette Electronics, Inc.
Cardiovascular · 27d
Cleared Oct 04, 1982
ELECTROCARDIOGRAPH (74 DPS) #YM-102
K822768 · DPS
Sanyo Electric, Inc.
Cardiovascular · 20d