FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,110 results
9337–9360 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 07, 1999
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH
K993774 · DXT
Acist Medical Systems
Cardiovascular · 29d
Cleared Dec 06, 1999
OPTISTAR MR INJECTOR SYSTEM
K984088 · DXT
Mallinckrodt Inc., Liebel-Flarsheim...
Cardiovascular · 385d
Cleared Dec 06, 1999
DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140
K990110 · DRX
Maersk Medical A/S
Cardiovascular · 327d
Cleared Dec 06, 1999
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570
K990111 · DRX
Maersk Medical A/S
Cardiovascular · 327d
Cleared Dec 06, 1999
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610
K990112 · DRX
Maersk Medical A/S
Cardiovascular · 327d
Cleared Dec 06, 1999
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND...
K990113 · DRX
Maersk Medical A/S
Cardiovascular · 327d
Cleared Dec 06, 1999
DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440
K990115 · DRX
Maersk Medical A/S
Cardiovascular · 327d
Cleared Dec 03, 1999
HL148 & HL168
K990807 · DXN
Health & Life Co., Ltd.
Cardiovascular · 267d
Cleared Dec 03, 1999
COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED &...
K993001 · DTN
Cobe Cardiovascular, Inc.
Cardiovascular · 87d
Cleared Dec 03, 1999
MODIFICATION TO CARTO EP NAVIGATION SYSTEM
K993729 · DQK
Biosense Webster, Inc.
Cardiovascular · 29d
Cleared Dec 02, 1999
ENSITE 3000 SYSTEM
K992479 · DQK
Endocardial Solutions, Inc.
Cardiovascular · 129d
Cleared Dec 01, 1999
HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A
K992977 · MKJ
Hewlett-Packard Co.
Cardiovascular · 89d
Cleared Dec 01, 1999
DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-181
K993890 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 15d
Cleared Nov 29, 1999
MAC-LAB SYSTEM
K992948 · DQK
General Electric Medical Systems...
Cardiovascular · 90d
Cleared Nov 26, 1999
SYNEFLASH & SYNEVIEW
K990727 · DQK
Ela Medical, Inc.
Cardiovascular · 266d
Cleared Nov 26, 1999
ECG ELECTRODE (VARIOUS)
K991105 · DRX
Conmedcorp
Cardiovascular · 239d
Cleared Nov 26, 1999
DASH 3000 PATIENT MONITOR
K992929 · MHX
General Electric Medical Systems...
Cardiovascular · 87d
Cleared Nov 26, 1999
CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085
K992965 · DRF
Cordis Webster, Inc.
Cardiovascular · 85d
Cleared Nov 26, 1999
MEDRAD ENVISION CT INJECTOR SYSTEM
K993728 · DXT
Medrad, Inc.
Cardiovascular · 22d
Cleared Nov 24, 1999
DIGITRAKPLUS HOLTER RECORDER
K993617 · MWJ
Braemar Corp.
Cardiovascular · 29d
Cleared Nov 24, 1999
DXP1000 HOLTER RECORDER
K993618 · MWJ
Braemar Corp.
Cardiovascular · 29d
Cleared Nov 24, 1999
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER
K993648 · MCW
Boston Scientific Corporation...
Cardiovascular · 26d
Cleared Nov 23, 1999
STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS
K990512 · KRI
Stoeckert Instrumente
Cardiovascular · 278d
Cleared Nov 19, 1999
SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS
K992832 · DSY
Sulzermedica
Cardiovascular · 88d