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
16753–16776 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 25, 1981
PRESSURE FUNCTION BLOCKS
K810172 · DSK
Honeywell, Inc.
Cardiovascular · 34d
Cleared Feb 25, 1981
ECG FUNCTION BLOCK
K810176 · DPS
Honeywell, Inc.
Cardiovascular · 34d
Cleared Feb 25, 1981
PATIENT MONITOR MODEL CM130, 140
K810177 · DXG
Honeywell, Inc.
Cardiovascular · 34d
Cleared Feb 25, 1981
PATIENT MONITOR CM111, 112
K810178 · DSK
Honeywell, Inc.
Cardiovascular · 34d
Cleared Feb 25, 1981
DUAL TRACE PATIENT MONITOR 116,118,120
K810179 · DSK
Honeywell, Inc.
Cardiovascular · 34d
Cleared Feb 23, 1981
PACING SYSTEM ANALYZER
K803313 · DTE
Medtronic Vascular
Cardiovascular · 54d
Cleared Feb 19, 1981
DISPOSABLE DIAPHRAGM DOME
K810009 · DRS
Medex, Inc.
Cardiovascular · 45d
Cleared Feb 19, 1981
PORTABLE, BATTERY OPERATED DEFIBRILLATOR
K810237 · LDD
Honeywell, Inc.
Cardiovascular · 22d
Cleared Feb 19, 1981
MICROPROCESSOR CONTROLLED ELECTROCARDIO
K810263 · DPS
Honeywell, Inc.
Cardiovascular · 20d
Cleared Feb 13, 1981
INTERMEDICS CYBERLITH I UNIPOLAR CARDIAC
K810384
Intermedics, Inc.
Cardiovascular
Cleared Feb 12, 1981
MULTI-PROGRAMMABLE PACEMAKER & PROGRMR.
K801584 · DXY
Medtronic Vascular
Cardiovascular · 216d
Cleared Feb 12, 1981
TELEMETRY PACEMAKER MONITOR
K802357 · DRG
Intermedics, Inc.
Cardiovascular · 139d
Cleared Feb 09, 1981
POLY FLEX IMPLANTABLE PACING LEAD
K802295 · DTB
Intermedics, Inc.
Cardiovascular · 143d
Cleared Feb 05, 1981
PACEMAKER PATIENT MGMT. SYSTEM
K801810 · DQK
Siemens Elema AB
Cardiovascular · 190d
Cleared Feb 05, 1981
IMPLANTABLE VENTRICULAR-INHIBITED CARDI
K802175
Telectronics, Inc.
Cardiovascular · 149d
Cleared Feb 05, 1981
SIEMENS-ELEMA PULSE GENERATOR 678
K802864 · DXY
Siemens Elema AB
Cardiovascular · 85d
Cleared Feb 05, 1981
CORDIS TEMPORATY CURVED ATRIAL LEAD
K810041 · LDF
Cordis Corp.
Cardiovascular · 29d
Cleared Feb 05, 1981
CORDIS MULTIFILAR PERVENOUS VENTRIC. LD
K810202 · DTB
Cordis Corp.
Cardiovascular · 13d
Cleared Feb 04, 1981
SWAN-GANZ VIP THERMODILUTION CATHETER
K810124 · DYG
American Edwards Laboratories
Cardiovascular · 16d
Cleared Feb 04, 1981
FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06
K810162 · DXC
American Edwards Laboratories
Cardiovascular · 13d
Cleared Feb 02, 1981
IONESCU-SHILEY AORTIC GRAFT VALVE
K803000 · DSY
Shiley, Inc.
Cardiovascular · 69d
Cleared Jan 30, 1981
SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS
K810079 · KRI
3M Health Care, Sarns
Cardiovascular · 17d
Cleared Jan 29, 1981
SIEMENS-ELEMA MYOCARDIAL LEAD
K810036 · DXY
Siemens Elema AB
Cardiovascular · 20d
Cleared Jan 29, 1981
INFANT ECG ELECTRODE #60-1029
K810102 · DRX
Aspen Laboratories, Inc.
Cardiovascular · 13d