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
16705–16728 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 01, 1981
UNIPOLAR SPECTRAX IMPL. PULSE GENERAT.
K811350 · DXY
Medtronic Vascular
Cardiovascular · 49d
Cleared Jul 01, 1981
CORDIS ENCOR PEWENOUS VENTRICULAR BIPOL
K811539 · DTB
Cordis Corp.
Cardiovascular · 30d
Cleared Jul 01, 1981
MEDDARS/ULTRA IMAGER PULSE/PHON MODULE
K811626 · DQC
Honeywell, Inc.
Cardiovascular · 22d
Cleared Jun 30, 1981
CENTRAL STATION MONITORING SYSTEMS
K811121 · DPS
Cambridge Instruments, Inc.
Cardiovascular · 67d
Cleared Jun 30, 1981
VITA-STAT MODEL 8000-C
K811146 · DSK
Vita-Stat
Cardiovascular · 64d
Cleared Jun 30, 1981
VITA-STAT MODEL 9000-A
K811147 · DSK
Vita-Stat
Cardiovascular · 64d
Cleared Jun 30, 1981
VITA-STAT MODEL 9000-S
K811148 · DSK
Viat-Stat
Cardiovascular · 64d
Cleared Jun 30, 1981
OCCLUSION CATHETER
K811276 · DYG
Bionomy, Inc.
Cardiovascular · 53d
Cleared Jun 30, 1981
MODEL 5866-24 LEAD ADAPTOR KIT
K811349 · DTD
Medtronic Vascular
Cardiovascular · 48d
Cleared Jun 30, 1981
TELETRACE TELEPHONE EKG SYSTEM
K811512 · DXH
Medtronic Vascular
Cardiovascular · 33d
Cleared Jun 30, 1981
NORELCO ANEROID BLOOD PRESSURE METER
K811634 · DXQ
North American Philips Corp.
Cardiovascular · 20d
Cleared Jun 30, 1981
NORELCO DIGITAL BLOOD PRESSURE METER
K811635 · DXN
North American Philips Corp.
Cardiovascular · 20d
Cleared Jun 30, 1981
NORELCO ELECTRONIC BLOOD PRESSURE METER
K811636 · DXN
North American Philips Corp.
Cardiovascular · 20d
Cleared Jun 18, 1981
MODEL SP 5507 5-LUMEN THERMODILUTION CAT
K811537 · KRB
Gould, Inc.
Cardiovascular · 17d
Cleared Jun 18, 1981
AUTOMATED PHYSIOLOGIC PROFILE MONITOR
K811560 · DXG
Life Sciences Manufacturing, Inc.
Cardiovascular · 16d
Cleared Jun 16, 1981
#325 PROGRAMMABLE CARD. PULSE GENERATOR
K810884 · DXY
Cook Pacemaker Corp.
Cardiovascular · 76d
Cleared Jun 16, 1981
#326 PROGRAMMABLE CARD. PULSE GENERATOR
K810885 · DXY
Cook Pacemaker Corp.
Cardiovascular · 76d
Cleared Jun 16, 1981
CC-103
K811527 · DSI
Anthro-Metrics Corp.
Cardiovascular · 15d
Cleared Jun 16, 1981
CARDIFF ALDASORBER SYSTEM
K811703
William Harvey Life Products Corp.
Cardiovascular
Cleared Jun 12, 1981
SYPHGMOLOG
K811079 · DSK
Cardiodyne General, Inc.
Cardiovascular · 52d
Cleared Jun 12, 1981
DEL MAR AVIONICS MODELS 9400 & 9401
K811122 · DSI
Del Mar Avionics
Cardiovascular · 49d
Cleared Jun 12, 1981
MEDI-TRACE
K811410 · KRA
Graphic Controls Corp.
Cardiovascular · 24d
Cleared Jun 12, 1981
SWAN-GANZ HEPARIN COATED, ETC. CATHETER
K811411 · KRB
American Edwards Laboratories
Cardiovascular · 24d
Cleared Jun 12, 1981
BAIM CORONARY SINUS FLOW ANALYZER
K811414 · DXG
Electro-Catheter Corp.
Cardiovascular · 24d