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
12121–12144 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 24, 1991
E560 ELECTROCARDIOGRAPH
K903565 · LOS
Burdick Corp.
Cardiovascular · 351d
Cleared Jul 24, 1991
ELITE II ELECTROCARDIOGRAPH
K904032 · LOS
Burdick Corp.
Cardiovascular · 327d
Cleared Jul 24, 1991
DC200 DEFIBRILLATOR
K910634 · LDD
Siemens Burdick, Inc.
Cardiovascular · 161d
Cleared Jul 24, 1991
SFA-II MICROPROCESSOR-CONTROLLED MODULE
K910905 · DRQ
Life Sciences Manufacturing, Inc.
Cardiovascular · 141d
Cleared Jul 23, 1991
MODEL 5866-9M & MODEL 6981M
K911827 · DTD
Metronic, Inc.
Cardiovascular · 90d
Cleared Jul 22, 1991
PULSATILE ANTI-EMBOLISM SYS.PUMP
K911853 · JOW
Baxter Healthcare Corp
Cardiovascular · 87d
Cleared Jul 22, 1991
CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED
K911935 · DRR
Gould, Inc.
Cardiovascular · 82d
Cleared Jul 22, 1991
BAXTER SINGLE PATIENT USE BLOOD PRESSURE CUFF
K912007 · DXQ
Tecnadyne Scientific, Inc.
Cardiovascular · 77d
Cleared Jul 19, 1991
CATH SHEATH INTRODUCER SYST PLUS W/UNISTASIS VALVE
K911794 · DYB
Cordis Corp.
Cardiovascular · 88d
Cleared Jul 18, 1991
FUTURECARE CARELYNK IV SYSTEM
K903512 · DRT
Futurecare Systems, Inc.
Cardiovascular · 349d
Cleared Jul 18, 1991
DATAMED MODEL 401A TRANSRECIEVER
K904966 · DXH
Datamed, Inc.
Cardiovascular · 255d
Cleared Jul 18, 1991
INJECTOR FILL TUBE
K911549 · DXT
The R Group
Cardiovascular · 101d
Cleared Jul 17, 1991
CARDIOCAP CMX-104 MONITOR
K903237 · DXN
Datex Division Instrumentarium Corp.
Cardiovascular · 359d
Cleared Jul 17, 1991
VITALMAX 2100/2200
K905274 · DRT
Pace Tech, Inc.
Cardiovascular · 244d
Cleared Jul 17, 1991
12-LEAD ECG ADAPTOR FOR USE W/LIFEPAK 10 DEFIB/MON
K910144 · LDD
Physio-Control Corp.
Cardiovascular · 184d
Cleared Jul 17, 1991
Q-SMART HOLTER SYSTEMS
K910808 · DSI
Quinton, Inc.
Cardiovascular · 141d
Cleared Jul 17, 1991
OLYMPUS AF ANGIOSCOPE SYSTEM
K911278 · LYK
Olympus Corp.
Cardiovascular · 114d
Cleared Jul 15, 1991
VASCULAR BIOPSY FORCEPS
K910840 · DWZ
Vascular Products, Inc.
Cardiovascular · 138d
Cleared Jul 12, 1991
MEDFLATOR INFLATION SYSTEM
K910958 · MAV
Medex, Inc.
Cardiovascular · 128d
Cleared Jul 12, 1991
ANGIOPLASTY INFLATOR
K911295 · MAV
Vastek
Cardiovascular · 109d
Cleared Jul 12, 1991
ROTATING HEMOSTATIC VALVE
K911678 · DYB
Devices For Vascular Intervention, Inc.
Cardiovascular · 88d
Cleared Jul 11, 1991
SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER
K910429 · DXO
Baxter Healthcare Corp
Cardiovascular · 160d
Cleared Jul 10, 1991
HORIZON XL
K911616 · DRT
Mennen Medical, Inc.
Cardiovascular · 90d
Cleared Jul 09, 1991
ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE
K900385 · DSI
Parexel Intl. Corp.
Cardiovascular · 526d