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
16273–16296 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 29, 1982
ADAPTATION OF KANTRON 40 CC. PDLIAB
K820166 · DSP
Kontron Instruments, Inc.
Cardiovascular · 98d
Cleared Apr 29, 1982
QUINTON Q2000 ETT MONITORING SYSTEM
K820438 · DSI
Quinton, Inc.
Cardiovascular · 71d
Cleared Apr 29, 1982
THERMO-K
K820814 · DWJ
American Medical Systems, Inc.
Cardiovascular · 36d
Cleared Apr 29, 1982
CARDIO REVUE CENTER
K820820 · DXG
Diasonics, Inc.
Cardiovascular · 36d
Cleared Apr 29, 1982
EVENTMASTER 2
K820856 · DSI
Instruments For Cardiac Research
Cardiovascular · 31d
Cleared Apr 29, 1982
SEPTISLEEVE
K820883 · DYG
Argon Medical Corp.
Cardiovascular · 30d
Cleared Apr 29, 1982
P-S BERLIN VESSEL CLAMP
K820949 · DXC
Pudenz-Schulte Medical Research Corp.
Cardiovascular · 23d
Cleared Apr 29, 1982
EKG MONITORS, VARIOUS MODELS
K820986 · DXH
Dart Medical Equipment
Cardiovascular · 23d
Cleared Apr 21, 1982
HOLTER ECG SCANNER
K820014 · DPS
Laser Scan Corp.
Cardiovascular · 106d
Cleared Apr 21, 1982
IL 7F FLOW DIRECTOR THERMAL DILU. CATH
K820702 · DYG
Instrumentation Laboratory CO
Cardiovascular · 37d
Cleared Apr 21, 1982
VASCULAB SPECTRUM ANALYZER #SP25
K820898 · DXG
Medasonics, Inc.
Cardiovascular · 22d
Cleared Apr 21, 1982
EKG TELEPHONE CONVERTER
K820904 · DXH
Dart Medical Equipment
Cardiovascular · 21d
Cleared Apr 16, 1982
PHONOTRACE 2000
K820452 · DXH
Lowrance Electronics, Inc.
Cardiovascular · 57d
Cleared Apr 16, 1982
IMPLANTIBLE SUTURE SLEEVE
K820487 · DTB
Intermedics, Inc.
Cardiovascular · 52d
Cleared Apr 16, 1982
MODEL 5866-26 LEAD ADAPTER KIT
K820935 · DTD
Medtronic Vascular
Cardiovascular · 14d
Cleared Apr 15, 1982
DISPOSABLE PLASTIC SYRINGE W/NEEDLE
K813223 · DXG
Sam Joo Industrial Co., Ltd.
Cardiovascular · 157d
Cleared Apr 15, 1982
ALGORITHM OF THE ARRHYTHMIA MON. SYS
K820477 · DSI
Hewlett-Packard Co.
Cardiovascular · 52d
Cleared Apr 15, 1982
ARTERIAL CANALIZATION DEVICE
K820516 · DQY
Alimed, Inc.
Cardiovascular · 49d
Cleared Apr 15, 1982
PULSE GENERATOR 678 B
K820657 · DXY
Siemens Elema AB
Cardiovascular · 37d
Cleared Apr 15, 1982
CENTRAL VENOUS ACCESS CATHETER
K820736 · DQY
Hemed, Inc.
Cardiovascular · 28d
Cleared Apr 15, 1982
NIHON KOHDEN BLOOD FLOWMETERS #MFV-1100
K820742 · DPW
Nihon Kohden America, Inc.
Cardiovascular · 28d
Cleared Apr 15, 1982
CARDIAC MONITOR - RATE ALARM
K820825 · DRT
Hewlett-Packard Co.
Cardiovascular · 21d
Cleared Apr 15, 1982
NORTON MANIFOLD
K820864 · DTL
Norton Performance Plastics Corp.
Cardiovascular · 17d
Cleared Apr 15, 1982
MARQUETTE OPTION II ECG ANALYSIS COMPUT
K820885 · LOS
Marquette Electronics, Inc.
Cardiovascular · 16d