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
17089–17112 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 16, 1980
MODEL 100 SPECTRAVIEW
K800655 · DQC
Edwards Laboratories
Cardiovascular · 22d
Cleared Apr 16, 1980
MEDI-TRACE TRANSDUCERS/PHYSIOLOG. MONITO
K800705 · DRS
Graphic Controls Corp.
Cardiovascular · 16d
Cleared Apr 16, 1980
MEDI-TRACE DISPOSABLE DOMES/MONITORING
K800706 · DRS
Graphic Controls Corp.
Cardiovascular · 16d
Cleared Apr 16, 1980
TOPICAL COOLING DEV. TCD. #27-999
K800717 · DTR
Cobe Laboratories, Inc.
Cardiovascular · 16d
Cleared Apr 16, 1980
CENTRAL VEIN CATHETERIZATION KIT
K800741 · DQO
Medical Components, Inc.
Cardiovascular · 13d
Cleared Apr 10, 1980
D668 & D664 CENTRAL MONITORING SYSTEMS
K800243 · DRT
Medtel Pty. , Ltd.
Cardiovascular · 65d
Cleared Apr 08, 1980
COMBISON COMPUTER
K800092 · DQK
Kt Medical, Inc.
Cardiovascular · 85d
Cleared Apr 08, 1980
PULSEOMETER
K800500 · DRT
Kirklands Sporting Goods Co.
Cardiovascular · 35d
Cleared Apr 08, 1980
CAMBRIDGE VS-550 ELECTROCARDIOGRAPH
K800566 · DPS
Cambridge Instruments, Inc.
Cardiovascular · 26d
Cleared Apr 08, 1980
ANGIOPLASTY INJECTOR
K800613 · DXT
Medrad, Inc.
Cardiovascular · 21d
Cleared Apr 08, 1980
CYBERLITH IMPLANTABLE PULSE GEN. #253-04
K800645 · DXY
Intermedics, Inc.
Cardiovascular · 15d
Cleared Apr 08, 1980
SCHILLER MSG-1
K800659 · DPS
Renesco International, Inc.
Cardiovascular · 13d
Cleared Apr 08, 1980
MODEL S/D-600 AUTO INFLATE CONTROL MODUL
K800661 · DXN
Applied Science Laboratories
Cardiovascular · 13d
Cleared Apr 08, 1980
MARK II
K800662 · DXN
Applied Science Laboratories
Cardiovascular · 13d
Cleared Apr 08, 1980
MARK III
K800663 · DXN
Applied Science Laboratories
Cardiovascular · 13d
Cleared Apr 08, 1980
MODIFIED CATHETER PACKAGE
K800703 · DQO
Hancock Laboratories, Inc.
Cardiovascular · 12d
Cleared Apr 04, 1980
PARTNER SEVEN DISP. BUBBLE OXYGENATOR
K800555 · DTZ
Cardiovascular Research, Inc.
Cardiovascular · 23d
Cleared Apr 02, 1980
PERCUTANEOUS CATHETER INTRODUCER
K800580 · DYB
Alva Medical, Inc.
Cardiovascular · 19d
Cleared Apr 02, 1980
SIRECUST 311S
K800593 · DPS
Siemens Corp.
Cardiovascular · 16d
Cleared Apr 02, 1980
MEDTEK #411 PORTABLE B-P INSTR.
K800614 · DXN
Med-Tek Corp.
Cardiovascular · 15d
Cleared Apr 02, 1980
FIBERGLASS CYLINDER BASES, #'S 65040-
K800665
B & F Medical Products, Inc.
Cardiovascular · 7d
Cleared Mar 25, 1980
SUSI II PACEMAKER SURVEILLANCE MONITOR
K792602 · DTC
Ela Medical, Inc.
Cardiovascular · 98d
Cleared Mar 25, 1980
DVT PREVENTION SYS. MBE 22 PRESSURE U.
K800337 · JOW
Med-Bio Engineering, Inc.
Cardiovascular · 39d
Cleared Mar 25, 1980
IMPLANTABLE PROGRAMMABLE BIPOLAR CARDIAC
K800573 · DXY
Telectronics, Inc.
Cardiovascular · 11d