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
15817–15840 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Not Cleared Jul 29, 1983
PROSTHETIC RINGS #4400 MITRAL & 4500
K831949 · KRH
American Edwards Laboratories
Cardiovascular · 43d
Cleared Jul 28, 1983
AMBULATORY ECG EVENT RECORDER
K830907 · DSH
Brentwood Instruments, Inc.
Cardiovascular · 129d
Cleared Jul 28, 1983
UNICUFF-BLOOD PRESSURE CUFF
K831001 · DXQ
Frontier Products
Cardiovascular · 121d
Cleared Jul 28, 1983
LIFESTAT 200
K831232 · DXN
Physio-Control Corp.
Cardiovascular · 104d
Cleared Jul 26, 1983
CARDIO ARRHYTHMIA TRANSMITTER C.A.T
K830903 · DXH
Cardio Technology , Ltd.
Cardiovascular · 127d
Cleared Jul 26, 1983
TEMP. BIPOLAR EPICARDIAL LEAD
K831645 · LDF
Cordic Corp.
Cardiovascular · 64d
Cleared Jul 26, 1983
PM-3
K831750 · DXS
Delta Medical Industries
Cardiovascular · 55d
Cleared Jul 26, 1983
IMPLANTABLE CARDIAC PACING LEADS
K831767 · DTB
Oscor, Inc.
Cardiovascular · 55d
Cleared Jul 26, 1983
UNIVERSAL LEVEL SENSOR
K831879 · DTW
3M Health Care, Sarns
Cardiovascular · 43d
Cleared Jul 26, 1983
MEDTRONIC MODELS 4012 & 4512
K832099 · DTB
Medtronic Vascular
Cardiovascular · 27d
Cleared Jul 19, 1983
VASCULAR GRAFT PROSTHESIS EXPANDED MICR
K830543 · DSY
Impra, Inc.
Cardiovascular · 147d
Cleared Jul 19, 1983
THE BLOOM STETHOSCOPE
K830796 · LDE
Stethophonics, Inc.
Cardiovascular · 127d
Cleared Jul 19, 1983
PECGASYS REMOTE TRANSMISSION UNIT
K831092 · DXH
Datamedix
Cardiovascular · 106d
Cleared Jul 19, 1983
COMPRESSAR DISPOSABLE DISC
K831337 · DQO
Instromedix, Inc.
Cardiovascular · 85d
Cleared Jul 19, 1983
GP-303
K831583 · DXN
Hirata Sangyo Co. USA, Inc.
Cardiovascular · 63d
Cleared Jul 18, 1983
WEDGE PRESSURE CATHETER
K830604 · DYG
Plasmedics, Inc.
Cardiovascular · 143d
Cleared Jul 18, 1983
APNEA/BRADYCARDIA MONITOR HB 95
K830666 · DPS
Harvey-Bostwick, Inc.
Cardiovascular · 136d
Cleared Jul 18, 1983
HYPER-HYPOTHERMIA UNIT HYPO 10-200
K831677 · DWC
Gambro, Inc.
Cardiovascular · 56d
Cleared Jul 18, 1983
WM. HARVEY PARALLEL PLATE MEMBRANE BLOOD
K831705 · DTZ
C.R. Bard, Inc.
Cardiovascular · 53d
Cleared Jul 18, 1983
PERCUTANEOUS CATHETER INSERTION TRAY
K831729 · DQY
American Pharmaseal Div. Ahsc
Cardiovascular · 48d
Cleared Jul 18, 1983
CONTINUOUS FLUSH DEVICE
K831730 · KRA
American Pharmaseal Div. Ahsc
Cardiovascular · 48d
Cleared Jul 18, 1983
CATHETER INSERTION TRAYS, VARIOUS #'S
K831807 · DQY
American Pharmaseal Div. Ahsc
Cardiovascular · 42d
Cleared Jul 18, 1983
STAINLESS STEEL GUIDE WIRE
K831839 · DQX
Quinton, Inc.
Cardiovascular · 41d
Cleared Jul 12, 1983
MICROVEL DOUBLE VELOUR SUPPORTED 100
K822633 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 315d