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
7369–7392 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 01, 2005
STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER
K043513 · NLH
Sterilmed, Inc.
Cardiovascular · 71d
Cleared Feb 28, 2005
MODIFICATION TO ENDOVASCULAR GUIDE WIRE
K043457 · DQX
Stereotaxis, Inc.
Cardiovascular · 75d
Cleared Feb 25, 2005
HOLTER RECORDER H3+
K043010 · MWJ
Mortara Instrument, Inc.
Cardiovascular · 116d
Cleared Feb 25, 2005
PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304
K050004 · MKJ
Philips Medical Systems
Cardiovascular · 54d
Cleared Feb 22, 2005
MEDICOMPASS CONNECT
K042768 · DXN
Imetrikus, Inc.
Cardiovascular · 140d
Cleared Feb 22, 2005
LIBERTY SYSTEM
K043074 · DPS
Inovise Medical, Inc.
Cardiovascular · 106d
Cleared Feb 22, 2005
MULTIPLE, MODEL KTJ-50
K043444 · DXQ
Golden Horse Medical Equipment (Wuxi)...
Cardiovascular · 70d
Cleared Feb 22, 2005
COMPATIBILITY ECG TRUNK CABLES
K043572 · DSA
Datex-Ohmeda
Cardiovascular · 57d
Cleared Feb 22, 2005
MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000
K050159 · DQD
3M Company
Cardiovascular · 28d
Cleared Feb 18, 2005
INFINITY KAPPA XLT
K042904 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 120d
Cleared Feb 18, 2005
INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C
K042984 · DWF
Intervascular
Cardiovascular · 112d
Cleared Feb 18, 2005
INFINITY MODULAR MONITORS WITH VF5 MODIFICATIONS (DELTA/KAPPA/DELTA XL/VISTA...
K043439 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 66d
Cleared Feb 18, 2005
DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) AND...
K043551 · MHX
Datex-Ohmeda
Cardiovascular · 57d
Cleared Feb 18, 2005
SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200,...
K043553 · MCW
Fox Hollow Technologies
Cardiovascular · 53d
Cleared Feb 18, 2005
SECURELOC
K050023 · DYB
Specialized Health Products, Inc.
Cardiovascular · 44d
Cleared Feb 17, 2005
SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018
K042308 · DYB
Facile Medical, Inc.
Cardiovascular · 176d
Cleared Feb 17, 2005
BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER
K042553 · DQY
Biocardia, Inc.
Cardiovascular · 150d
Cleared Feb 16, 2005
VASCON POLARIS GUIDING CATHETER
K043387 · DQY
Vascon, LLC
Cardiovascular · 69d
Cleared Feb 15, 2005
PLANET 50 MONITORING SYSTEM
K043370 · MWI
Larsen & Toubro Limited
Cardiovascular · 69d
Cleared Feb 15, 2005
LARGE BORE SPLITTABLE INTRODUCER KIT
K043438 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 63d
Cleared Feb 11, 2005
MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
K050073 · DQY
Invatec Innovative Technologies, S.R.L.
Cardiovascular · 30d
Cleared Feb 11, 2005
TRILLIUM BIOPUMP PLUS, MODEL BPX80T
K050109 · KFM
Medtronic Perfusion Systems
Cardiovascular · 24d
Cleared Feb 11, 2005
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 INTELLIVUE PATIENT...
K050141 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 17d
Cleared Feb 09, 2005
CATHETER INTRODUCER
K043525 · DYB
Galt Medical Corp.
Cardiovascular · 50d