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
14425–14448 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 20, 1986
TELEFLEX TEFLON COATED GUIDEWIRE
K860258 · DQX
Teleflexmedical, Inc.
Cardiovascular · 116d
Cleared May 20, 1986
PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET
K860307 · DYB
Teleflex, Inc.
Cardiovascular · 112d
Cleared May 20, 1986
QMED SYSTEM 2150
K861437 · DXG
Qmed, Inc.
Cardiovascular · 33d
Cleared May 19, 1986
THERAPY CASSETTS
K854920 · MCU
Alpha Therapeutic Corp.
Cardiovascular · 160d
Cleared May 19, 1986
LEAD BODY CHANGES TO HI PERFORM & FAST-PASS LEADS
K861464 · DTB
Pacesetter Systems
Cardiovascular · 28d
Cleared May 16, 1986
DINAMAP VITAL SIGNS MONITOR MODEL 8100
K854434 · DXN
Critikon Company, LLC
Cardiovascular · 192d
Cleared May 16, 1986
MODEL 535 NEO-TRAK RECORDER
K855045 · DSF
Ge Medical Systems Information...
Cardiovascular · 150d
Cleared May 16, 1986
CARDIAC MONITOR, CARDIOTACHOMETER AND ALARM
K861359 · DPS
Hewlett-Packard Co.
Cardiovascular · 36d
Cleared May 15, 1986
ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY)
K861483 · DQO
Mallinckrodt Critical Care
Cardiovascular · 28d
Cleared May 13, 1986
TRANSCOR (TM) RADIO-STETHOSCOPE
K854772 · DQD
K & S Medicorp
Cardiovascular · 165d
Cleared May 13, 1986
LEADS UTILIZ VOLUN STAND #1 3.2 MM UNI/BIOPOLAR CO
K861440 · DTB
Pacesetter Systems
Cardiovascular · 26d
Cleared May 13, 1986
VICKERS ERGOMATIC MICROSURG INSTRU CARDIAC SET
K861745 · DWS
Keeler Instruments, Inc.
Cardiovascular · 7d
Cleared May 12, 1986
OSCILLOMATE NEONATAL BLOOD PRESS. MONIT.-MODEL 901
K860196 · DXN
Cas Medical Systems, Inc.
Cardiovascular · 110d
Cleared May 09, 1986
VICKERS MEDICAL MODEL 271 HEART RATE MONITOR
K854597 · DRT
Vickers , Ltd.
Cardiovascular · 172d
Cleared May 09, 1986
SALTZMAN STETHOSCOPE HEAD
K854771 · LDE
K & S Medicorp
Cardiovascular · 161d
Cleared May 09, 1986
TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER, UA-731
K854797 · DXN
Takeda Medical, Inc.
Cardiovascular · 158d
Cleared May 09, 1986
MONARK 869 ERGOMETER
K855102 · DSP
Equilibrated Bio Systems, Inc.
Cardiovascular · 137d
Cleared May 09, 1986
FASTRACE III, ECG ELECTRODE
K860636 · DPS
Andover Medical, Inc.
Cardiovascular · 77d
Cleared May 09, 1986
SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS
K861559 · DXY
Cook Pacemaker Corp.
Cardiovascular · 14d
Cleared May 08, 1986
MEADOS INTRAORTIC GRAFT
K841596 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 750d
Cleared May 08, 1986
ECG MONITORING/DEFIBRILLATION ELECTRODE
K854433 · DRX
Andover Medical, Inc.
Cardiovascular · 184d
Cleared May 08, 1986
VASCULAR ACCESS PORT/CATH CAT.#VP-XXXX VASPORT SER
K854610 · DQY
Gish Biomedical, Inc.
Cardiovascular · 171d
Cleared May 08, 1986
ULTRASOUND TRANSDUCER #21230A 7.5MHZ SHORT FOCUS
K860652 · JOP
Hewlett-Packard Co.
Cardiovascular · 76d
Cleared May 08, 1986
BIOMECCA CARETAKER 1000 & 2000
K860790 · DPS
Biomecca Australia , Ltd.
Cardiovascular · 65d