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
16081–16104 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 01, 1982
CNIBP BLOOD PRESSURE MEASUREMENT SYS
K822055 · DXN
Ohio Medical Products
Cardiovascular · 111d
Cleared Nov 01, 1982
INTRAOPERATIVE BALLOON DILATION CATH.
K822393 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 84d
Cleared Nov 01, 1982
CENTURION CHART RECORDER
K822432 · DSF
Clinical Data, Inc.
Cardiovascular · 81d
Cleared Nov 01, 1982
MEDI-TRACE 5' OFFSET ELECTRODE
K822750 · DRX
Graphic Controls Corp.
Cardiovascular · 49d
Cleared Nov 01, 1982
BLOOD OXYGENATORS #BOS-105S BOS-5S W/
K822803 · DTZ
Bentley Laboratories, Inc.
Cardiovascular · 45d
Cleared Nov 01, 1982
BALLOON WEDGE PRESSURE, ANGIOGRAPHIC
K822806 · DYG
Nova Medical Specialties
Cardiovascular · 45d
Cleared Nov 01, 1982
ACCESS PERCUTANEOUS INTRODUCER SET
K822834 · DYB
Access Devices, Inc.
Cardiovascular · 41d
Cleared Nov 01, 1982
AUTOECHO
K822903 · DXG
Oxford Medilog, Inc.
Cardiovascular · 34d
Cleared Nov 01, 1982
KALOS-03 BIPOLAR
K822907 · DXY
Biotronik Sales, Inc.
Cardiovascular · 32d
Cleared Nov 01, 1982
560
K822952 · DRT
Kone Instruments, Inc.
Cardiovascular · 28d
Cleared Nov 01, 1982
MODEL 4242 TELE SYST ARRHYTHMIA MONITOR
K822955 · DXH
Medtronic Vascular
Cardiovascular · 27d
Cleared Nov 01, 1982
PORTA FIB III
K822961 · LDD
Narco Scientific
Cardiovascular · 27d
Cleared Nov 01, 1982
IL 801 THERMALDILUTION CARDIAC OUTPUT
K822972 · DXG
Instrumentation Laboratory CO
Cardiovascular · 24d
Cleared Nov 01, 1982
OPTICATH HEPARIN COATED, FLOW-DIRECT
K823007 · DYG
Oximetrix, Inc.
Cardiovascular · 20d
Cleared Oct 18, 1982
PECOR, PERCOR-DL, 10.5 FRENCH W/SMEC
K820882 · DSP
Datascope Corp.
Cardiovascular · 202d
Cleared Oct 18, 1982
NON-STETHO 7, UM-15TP
K821989 · DXN
Hirata Sangyo Co. USA, Inc.
Cardiovascular · 103d
Cleared Oct 18, 1982
SIEMENS SIRECUST SYSTEM
K822091
Analogic Corp.
Cardiovascular · 95d
Cleared Oct 18, 1982
TEFLON COATED GUIDE WIRES & CATHETER
K822586 · DQX
Universal Medical Instrument Corp.
Cardiovascular · 53d
Cleared Oct 18, 1982
LS6 ARRYTHMIA DISCRIMINATOR
K822616 · DSI
Life Science Instrumentation, Inc.
Cardiovascular · 49d
Cleared Oct 18, 1982
GAS-FLOW METER GFL 10
K822820 · DTX
Gambro, Inc.
Cardiovascular · 28d
Cleared Oct 18, 1982
GAMBRO BLOOD LEVEL DETECTOR LCS 10
K822821 · DTW
Gambro, Inc.
Cardiovascular · 28d
Cleared Oct 18, 1982
GAMBRO PRESSURE MONITOR PRM 10
K822822 · DXS
Gambro, Inc.
Cardiovascular · 28d
Cleared Oct 18, 1982
BRACHIAL CORONARY GUIDING CATHETER
K822862 · DQO
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 21d
Cleared Oct 18, 1982
THERMOSTATIC WATER MIXING VALVE TWV10
K822874 · DWC
Gambro, Inc.
Cardiovascular · 21d