FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cardiovascular ×
18,151 results
16873–16896 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 29, 1981
SIEMENS-ELEMA MYOCARDIAL LEAD
K810036 · DXY
Siemens Elema AB
Cardiovascular · 20d
Cleared Jan 29, 1981
INFANT ECG ELECTRODE #60-1029
K810102 · DRX
Aspen Laboratories, Inc.
Cardiovascular · 13d
Cleared Jan 29, 1981
ADULT ECG ELECTRODE #60-0724
K810103 · DRX
Aspen Laboratories, Inc.
Cardiovascular · 13d
Cleared Jan 29, 1981
ECG ARRHYTHMIA STIMULATOR
K810104 · DPS
Belmont Instrument Corp.
Cardiovascular · 13d
Cleared Jan 22, 1981
SIRECUST 400 SYSTEM PATIENT MONITORING
K802113 · DPS
Analogic Corp.
Cardiovascular · 141d
Cleared Jan 22, 1981
HP MODEL 4710A ECG TRANSMITTER
K802717 · DXH
Hewlett-Packard Co.
Cardiovascular · 83d
Cleared Jan 22, 1981
TERUMO HOLLOW FIBER OXYGENATOR
K802970 · DTZ
Terumo America, Inc.
Cardiovascular · 62d
Cleared Jan 22, 1981
INTERPULSE MEMBRANE OXYGENATION SYSTEM
K803003 · DTZ
Extracorporeal Medical Specialities,...
Cardiovascular · 57d
Cleared Jan 22, 1981
IMPL. PROGRAMMABLE BIPOLAR CARD.GEN.#274
K803197 · DXY
Telectronics, Inc.
Cardiovascular · 37d
Cleared Jan 22, 1981
CRITERION II RHYTHM PROFILE MONITOR
K803315 · DXH
Dart Medical Equipment
Cardiovascular · 23d
Cleared Jan 22, 1981
PEDIATRIC ARTERIAL BLOOD FILTER
K810068 · DTM
Delta Medical Industries
Cardiovascular · 9d
Cleared Jan 16, 1981
DISPOSABLE GAS LINE FILTER
K802539 · KRI
Texas Medical Products, Inc.
Cardiovascular · 93d
Cleared Jan 16, 1981
DISPOSABLE PARALLEL Y CONNECTORS
K802541 · KRI
Texas Medical Products, Inc.
Cardiovascular · 93d
Cleared Jan 16, 1981
DISPOSABLE CONNECTORS
K802542 · KRI
Texas Medical Products, Inc.
Cardiovascular · 93d
Cleared Jan 16, 1981
RIDGID VENA CAVA CANNULAE
K802543 · DWF
Texas Medical Products, Inc.
Cardiovascular · 93d
Cleared Jan 16, 1981
DISPOSABLE QUICK RELEASE PERFUSION ADAP
K802544 · DTL
Texas Medical Products, Inc.
Cardiovascular · 93d
Cleared Jan 16, 1981
CARDIOPLEGIC SETS
K802545 · DTR
Texas Medical Products, Inc.
Cardiovascular · 93d
Cleared Jan 16, 1981
PERMANENT & TEMP. PACEMAKER ELECTRODE
K802547 · DTB
Daig Corp.
Cardiovascular · 93d
Cleared Jan 16, 1981
PERM. ENDOCARDIAL UNIPOLAR TINED/WEDGE
K802552 · DTB
Daig Corp.
Cardiovascular · 93d
Cleared Jan 16, 1981
PERM. ENDOCARDIAL UNIPOLAR WEDGE URETHAN
K802553 · DTB
Daig Corp.
Cardiovascular · 93d
Cleared Jan 16, 1981
ENDOCARDIAL LEADS 414S & 515S
K802816 · DTB
Siemens Elema AB
Cardiovascular · 70d
Cleared Jan 16, 1981
MARK III ULTRASONIC SCANNING SYSTEM
K802917 · DXK
Advanced Technology Laboratories, Inc.
Cardiovascular · 58d
Cleared Jan 16, 1981
SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH.
K803058 · LDF
American Edwards Laboratories
Cardiovascular · 45d
Cleared Jan 16, 1981
THB 6000 HARDSHELL BUBBLE OXYGENATOR
K803231 · DTZ
Travenol Laboratories, S.A.
Cardiovascular · 25d