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
16729–16752 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 11, 1981
STRESS TEST SYSTEM
K810357 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 29d
Cleared Mar 11, 1981
BAIM TM CORONARY SINUS FLOW THERMAL
K810360 · DQO
Electro-Catheter Corp.
Cardiovascular · 29d
Cleared Mar 11, 1981
NARCO TLECARE MINIATURE PRESSURE DOME
K810431 · DRS
Narco Bio-Systems
Cardiovascular · 20d
Cleared Mar 11, 1981
BURRON PERCUTANEOUS INDUCER SET
K810460 · DQY
Burron Medical Products, Inc.
Cardiovascular · 19d
Cleared Mar 11, 1981
BURRON CENTRAL VEIN CATHERIZATION KIT
K810461 · DQY
Burron Medical Products, Inc.
Cardiovascular · 19d
Cleared Mar 09, 1981
ELA MEDICAL PACING LEAD MODEL PMA 860
K810626
Ela Medical, Inc.
Cardiovascular
Cleared Mar 05, 1981
CPS-1000
K802890 · DTN
Gics Pharmaceuticals
Cardiovascular · 108d
Cleared Mar 05, 1981
AM 420 MICROPROCESSOR
K810163 · DXG
Honeywell, Inc.
Cardiovascular · 42d
Cleared Mar 05, 1981
MEADOX SZILAGYI GRAFT
K810376 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 21d
Cleared Mar 05, 1981
PRE-BYPASS FILTER
K810395 · KRJ
Texas Medical Products, Inc.
Cardiovascular · 15d
Cleared Mar 05, 1981
STERILE PACKAGING
K810410 · DXY
Telectronics, Inc.
Cardiovascular · 15d
Cleared Mar 05, 1981
USCI CARDIOVASCULAR CATHETER
K810412 · DQO
C.R. Bard, Inc.
Cardiovascular · 15d
Cleared Mar 04, 1981
OPTION 301 PACEMAKER EVAL. MODULE MAC-1
K802368 · DPS
Marquette Electronics, Inc.
Cardiovascular · 156d
Cleared Mar 04, 1981
IMPLANTABLE PACEMAKER LEAD ADAPTER
K810245 · DTD
Intermedics, Inc.
Cardiovascular · 34d
Cleared Mar 04, 1981
ELECATH DUAL MODE TRANSTHORACIC PACING
K810312 · LDF
Electro-Catheter Corp.
Cardiovascular · 27d
Cleared Feb 27, 1981
GUARDIAN MONITOR (CARDIOVASCULAR)
K803282 · DSI
Bd Becton Dickinson Vacutainer...
Cardiovascular · 60d
Cleared Feb 25, 1981
VC 430 VIDEO CONVERTER
K810164 · DXJ
Honeywell, Inc.
Cardiovascular · 34d
Cleared Feb 25, 1981
DUAL TRACE VIDEO MONITOR VM 410
K810165 · DXJ
Honeywell, Inc.
Cardiovascular · 34d
Cleared Feb 25, 1981
1,2,3 CHANNELL RECORDERS (AR150,AR250,-)
K810166 · DSF
Honeywell, Inc.
Cardiovascular · 34d
Cleared Feb 25, 1981
SINGLE CHANNELL RECORDER AR110
K810167 · DSF
Honeywell, Inc.
Cardiovascular · 34d
Cleared Feb 25, 1981
SLAVE MONITORS DC109 & VS109
K810168 · DXJ
Honeywell, Inc.
Cardiovascular · 34d
Cleared Feb 25, 1981
CENTRAL STATION CONTROLLER AC100/CE100
K810169 · DSF
Honeywell, Inc.
Cardiovascular · 34d
Cleared Feb 25, 1981
TREND GRAPH FUNCTION BLOCK
K810170 · DXG
Honeywell, Inc.
Cardiovascular · 34d
Cleared Feb 25, 1981
PERIPHERAL PULSE FUNCTION BLOCKS
K810171 · DSK
Honeywell, Inc.
Cardiovascular · 34d