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
16393–16416 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 29, 1981
MICRO-PREPROCESSOR UNIT
K812914 · DSI
General Electric Co.
Cardiovascular · 71d
Cleared Dec 29, 1981
EAST WATER UNIT MARK 3
K812955 · DWJ
Cairco , Ltd.
Cardiovascular · 69d
Cleared Dec 29, 1981
CARDIOINTEGRAM
K812971 · DXG
Ocg Technology, Inc.
Cardiovascular · 68d
Cleared Dec 29, 1981
TELEMETRY TRANSMITTER & RECEIVER
K813064 · DRG
Honeywell, Inc.
Cardiovascular · 60d
Cleared Dec 29, 1981
GEL ELECTRODE
K813176 · DRX
Dyn-A-Med Products
Cardiovascular · 47d
Cleared Dec 29, 1981
MEDIFIX GRADUATED SCALE
K813195 · KRK
Burron Medical Products, Inc.
Cardiovascular · 47d
Cleared Dec 29, 1981
MODEL 4200 ELLESTAD STRESS TEST ANALYZER
K813222 · DXG
Del Mar Avionics
Cardiovascular · 50d
Cleared Dec 29, 1981
TEMPERATURE PROBES
K813271 · KRI
Webster Laboratories, Inc.
Cardiovascular · 39d
Cleared Dec 29, 1981
VENOUS CANNULA TRAY
K813284 · DWS
Cunningham Woodland, Inc.
Cardiovascular · 36d
Cleared Dec 29, 1981
THIGH CUFF: X-LARGE CUFF
K813323 · DXQ
Abco Dealers, Inc.
Cardiovascular · 35d
Cleared Dec 29, 1981
P51 ANGIOPLASTY PRESSURE TRANSDUCER
K813331 · LIT
Konigsberg Instruments, Inc.
Cardiovascular · 35d
Cleared Dec 29, 1981
GERARD MEDICAL ELECTRODE TESTER
K813358 · KRC
Gerard Medical Enterprises, Inc.
Cardiovascular · 29d
Cleared Dec 29, 1981
NIHON KOHDEN HEART MONITORS OMP 7101-02
K813444 · DRT
Nihon Kohden America, Inc.
Cardiovascular · 20d
Cleared Dec 29, 1981
PERCUTANEOUS ENTRY NEEDLE, SELDINGER
K813461 · DRE
Ocean Medical Products, Ltd.
Cardiovascular · 18d
Cleared Dec 29, 1981
LINE POWERED LOW ENERGY DEFIBRILLATOR II
K813471 · LDD
Narco Scientific
Cardiovascular · 15d
Cleared Dec 29, 1981
OMED DISPOSABLE BULLDOG
K813499 · DXC
Omega-Med Intl., Inc.
Cardiovascular · 15d
Cleared Dec 29, 1981
NARCO TELECARE ISOFLO PRESSURE MONITOR
K813502 · DRS
Narco Bio-Systems
Cardiovascular · 14d
Cleared Dec 29, 1981
EDSLAB CATHETER COVER
K813514 · DQY
American Edwards Laboratories
Cardiovascular · 14d
Cleared Dec 14, 1981
TERUMO HOLLOW OXYGENATOR CIRCUIT
K812659 · DTM
Terumo Medical Corp.
Cardiovascular · 87d
Cleared Dec 14, 1981
TERUMO HOLLOW FIBER OXYGENATOR
K812660 · DTZ
Terumo Medical Corp.
Cardiovascular · 87d
Cleared Dec 14, 1981
BLOOD PRESSURE MONITOR
K812936 · DXN
Amertek
Cardiovascular · 55d
Cleared Dec 14, 1981
BOMED-NCCOM
K813020 · DXG
Bomed Medical Mfr., Ltd.
Cardiovascular · 48d
Cleared Dec 14, 1981
FUKUDA DENSHI...ELECTROCARDIOGRAPH FD-36
K813021 · DPS
Brentwood Instruments, Inc.
Cardiovascular · 48d
Cleared Dec 14, 1981
FLOWGUARD CATHETERS & CANNALAE
K813037 · DWF
Advocacy International, Ltd.
Cardiovascular · 47d