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
16537–16560 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 16, 1981
PERM. ENDOCARDIAL UNIPOLAR TINED ATRIAL
K812270 · DTB
Diag Corp.
Cardiovascular · 34d
Cleared Sep 09, 1981
ANGIOSCAN SPECTRUM ANALYZER
K812184 · DXK
Unigon Industries, Inc.
Cardiovascular · 37d
Cleared Sep 08, 1981
NOVAMETRIX PHYSIOLOGICAL MONITOR #910
K811893 · DRT
Novametrix Medical Systems, Inc.
Cardiovascular · 69d
Cleared Aug 31, 1981
NEOLOOPS
K810890 · DWS
Medical Marketing Systems
Cardiovascular · 151d
Cleared Aug 31, 1981
BO MED BIA
K811999 · DSB
Bomed Medical Mfr., Ltd.
Cardiovascular · 51d
Cleared Aug 31, 1981
CARDIO-DATA SYSTEM, #MARK III
K812149 · DSI
Cardio Data
Cardiovascular · 34d
Cleared Aug 31, 1981
MEDTRONIC SPECTRAX
K812153 · DXY
Medtronic Vascular
Cardiovascular · 33d
Cleared Aug 31, 1981
CORDIS DUCOR PERCUT. TRANS. ANGIO. CATH.
K812168 · LIT
Cordis Corp.
Cardiovascular · 32d
Cleared Aug 31, 1981
DACRON PLEDGET SUTURE BUTTRESS
K812254 · DXZ
Ethicon, Inc.
Cardiovascular · 19d
Cleared Aug 31, 1981
CENTRAL STATION MONITOR
K812271 · DRT
Datascope Corp.
Cardiovascular · 18d
Cleared Aug 25, 1981
ELECTRONIC STETHOSCOPE #S-50
K812148 · DQD
Syphgmostat
Cardiovascular · 28d
Cleared Aug 25, 1981
INTERFACE PRE BYPASS PRIME FILTER
K812240 · KRJ
Medical, Inc.
Cardiovascular · 14d
Cleared Aug 25, 1981
INTERFACE CARDIOTOMY BLOOD FILTER #51
K812243 · JOD
Medical, Inc.
Cardiovascular · 14d
Cleared Aug 25, 1981
INTERFACE PRE BYPASS PRIME FILTER #90
K812244 · KRJ
Medical, Inc.
Cardiovascular · 14d
Cleared Aug 20, 1981
GORE-TEX VASULAR GRAFT
K811510 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 85d
Cleared Aug 18, 1981
INTRODUCER, PERCUTANEOUS
K812143 · DYB
Willson
Cardiovascular · 21d
Cleared Aug 18, 1981
FLUSHFLO II
K812173 · KRA
Bentley Laboratories, Inc.
Cardiovascular · 15d
Cleared Aug 13, 1981
PACEPATH IMPLANTABLE ENDOCARD. PACING LD
K811200 · DTB
Pacesetter Systems
Cardiovascular · 105d
Cleared Aug 13, 1981
ULTRASONIC QFM SYSTEM 1000
K811376 · DPW
Narco Bio-Systems
Cardiovascular · 90d
Cleared Aug 13, 1981
SPACELABS' SYSTEM AUTORECORDER
K811540 · DSF
Spacelabs, Inc.
Cardiovascular · 73d
Cleared Aug 13, 1981
ARRHYTHMIA FUNCTION BLOCK
K811581 · DSI
Honeywell, Inc.
Cardiovascular · 69d
Cleared Aug 13, 1981
HEMOTHERM MODEL 400
K811742 · DWJ
Cincinnati Sub-Zero
Cardiovascular · 55d
Cleared Aug 13, 1981
ADAPTAID LEAD ADAPTER, #365-17
K811920 · DTD
Intermedics, Inc.
Cardiovascular · 42d
Cleared Aug 13, 1981
KENL-ECG-3
K811949 · DPS
Suzuken Co., Ltd.
Cardiovascular · 37d