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
10489–10512 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 04, 1996
SAMS 8000 CARDIOPLEGIA MONITOR
K960916 · DSJ
3M Health Care, Sarns
Cardiovascular · 90d
Cleared May 31, 1996
AS/3 CARDIAC OUTPUT & SVO2 MODULE
K961063 · DQK
Datex Medical Instrumentation, Inc.
Cardiovascular · 74d
Cleared May 30, 1996
MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR...
K955460 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 183d
Cleared May 30, 1996
PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90)
K960449 · DPS
Biosensor Corp.
Cardiovascular · 121d
Cleared May 30, 1996
MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT
K960983 · MAV
Medtronics Interventional Vascular
Cardiovascular · 80d
Cleared May 29, 1996
SOLAR 9000 ANESTHESIA INFORMATION MONITOR
K954852 · DSI
Marquette Electronics, Inc.
Cardiovascular · 219d
Cleared May 29, 1996
OCCLUSION BALLOON CATHETER
K960832 · MJN
Interventional Therapeutics Corp.
Cardiovascular · 90d
Cleared May 23, 1996
PRECLUDE IMA SLEEVE
K960532 · MFX
W.L. Gore & Associates, Inc.
Cardiovascular · 106d
Cleared May 23, 1996
CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS
K960755 · DQX
Medtronic Cardiac Surgery, Medtronic,...
Cardiovascular · 90d
Cleared May 22, 1996
QUEST EXERCISE STRESS SYSTEM
K952417 · DSI
Burdick, Inc.
Cardiovascular · 365d
Cleared May 22, 1996
MODEL 5471 & 5471L STERILE DISPOSABLE PATIENT CABLE ASSEMBLIES
K960446 · DSA
Medtronic Vascular
Cardiovascular · 111d
Cleared May 21, 1996
LRM
K960718 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 90d
Cleared May 17, 1996
UNILECT, MONITAB AND BIOTRACE-HR
K944497 · DRX
Msb , Ltd.
Cardiovascular · 612d
Cleared May 17, 1996
SI2000 (SENSE-IT TRADEMARK) OR G2000
K955800 · DRX
Cmc Sense-It, Inc.
Cardiovascular · 147d
Cleared May 16, 1996
BIOTRACE-N, NS, 410 AND RT
K944496 · DRX
Msb , Ltd.
Cardiovascular · 611d
Cleared May 16, 1996
CONMED ECG/EKG ELECTRODES
K954389 · DRX
Conmedcorp
Cardiovascular · 240d
Cleared May 16, 1996
CRICKET
K955304 · DQX
Microvena Corp.
Cardiovascular · 178d
Cleared May 15, 1996
MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER
K954457 · KRA
Medi-Tech, Inc.
Cardiovascular · 233d
Cleared May 15, 1996
PAGEWRITER 200, 200I CARDIOGRAPH & INTERPRETIVE CARDIO
K954980 · LOS
Hewlett-Packard Co.
Cardiovascular · 197d
Cleared May 15, 1996
DIASTAT VASCULAR ACCESS GRAFT
K955533 · DYF
W.L. Gore & Associates, Inc.
Cardiovascular · 162d
Cleared May 15, 1996
RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY
K955689 · DWS
Contour Fabricators of Florida, Inc.
Cardiovascular · 153d
Cleared May 15, 1996
8 FR.-40CC ARROW FLEX INTRA-AORTIC BALLOON CATHETER WITH BLUE FLEX TIP,...
K960713 · DSP
Arrow Intl., Inc.
Cardiovascular · 84d
Cleared May 15, 1996
SCIMED CHOICE/PTCA GUIDE WIRE/PLUS PTCA GUIDE WIRE/EXCHANGE PTCA GUIDE WIRE
K961015 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 63d
Cleared May 15, 1996
SCIMED 6-10 F TRIGUIDE GUIDE CATHETERS 6F,7F,8F,9F & 10F
K961280 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 42d