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
8737–8760 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 25, 2001
STREERABLE PTCA GUIDEWIRE
K011968 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 30d
Cleared Jul 24, 2001
MODIFICATION TO FLEXVIEW CLINICAL MONITORING SYSTEM
K011999 · MSX
Data Critical Corp.
Cardiovascular · 27d
Cleared Jul 24, 2001
MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM
K012005 · MSX
Data Critical Corp.
Cardiovascular · 27d
Cleared Jul 24, 2001
MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS
K012171 · MSX
Visicu, Inc.
Cardiovascular · 12d
Cleared Jul 20, 2001
NIEN MADE NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS HP-BPM0001
K011310 · DXN
Nien Made Electrnics Corp.
Cardiovascular · 81d
Cleared Jul 20, 2001
CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM
K011345 · DXH
Reynolds Medical , Ltd.
Cardiovascular · 79d
Cleared Jul 20, 2001
ROSSMAX SMARTINFLATE CARDIOPRO, MODEL 1000I AND MODEL 3000I BLOOD PRESSURE...
K011352 · DXN
Rossmax International , Ltd.
Cardiovascular · 78d
Cleared Jul 20, 2001
ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS
K011539 · DXN
Rossmax International , Ltd.
Cardiovascular · 63d
Cleared Jul 20, 2001
INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II
K012016 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 22d
Cleared Jul 20, 2001
MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A
K012094 · MWI
Agilent Technologies, Inc.
Cardiovascular · 15d
Cleared Jul 20, 2001
BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110
K012194 · DXQ
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 7d
Cleared Jul 19, 2001
SPLITTABLE SHEATH INTRODUCER KIT
K004025 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 204d
Cleared Jul 13, 2001
MALLEABLE SHAFT CLAMP
K011078 · DXC
Allegiance Healthcare Corp.
Cardiovascular · 95d
Cleared Jul 13, 2001
AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM
K011779 · DXN
Avid Care Corp.
Cardiovascular · 36d
Cleared Jul 13, 2001
LIFECARD CF 7 DAY
K011837 · MWJ
Reynolds Medical , Ltd.
Cardiovascular · 31d
Cleared Jul 13, 2001
ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE
K011847 · DRF
Zynergy Cardio Vasular (Zcv), Inc.
Cardiovascular · 30d
Cleared Jul 13, 2001
LIFESOURCE MODELS UA-787, UA 787PC, UA-787T
K012013 · DXN
A&D Engineering, Inc.
Cardiovascular · 15d
Cleared Jul 12, 2001
MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B
K011395 · KRH
Medtronic Vascular
Cardiovascular · 66d
Cleared Jul 12, 2001
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
K011557 · DXF
NuMED, Inc.
Cardiovascular · 52d
Cleared Jul 11, 2001
VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201
K003551 · DTN
Jostra AG
Cardiovascular · 236d
Cleared Jul 09, 2001
BRAIDED GUIDING INTRODUCER
K004026 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 194d
Cleared Jul 09, 2001
GUIDEWIRE INTRODUCER SAFETY NEEDLE
K011085 · DYB
Medamicus, Inc.
Cardiovascular · 90d
Cleared Jul 09, 2001
CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X
K011804 · DTM
Terumo Cardiovascular Systems Corp.
Cardiovascular · 28d
Cleared Jul 09, 2001
TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B
K011864 · DTN
Medtronic Vascular
Cardiovascular · 25d