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
9913–9936 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 19, 1997
RADIAL AND FEMORAL ARTERY CATHETER
K971086 · DQX
B.Braun Medical, Inc.
Cardiovascular · 269d
Cleared Dec 19, 1997
TOMCAT GUIDE WIRE, EXTENDER WIRE, GUIDE WIRE EXTENSION TOOL
K973708 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 81d
Cleared Dec 19, 1997
ELECTRODE, ELECTROCARDIOGRAPH
K973727 · DRX
Don Tay Industries
Cardiovascular · 80d
Cleared Dec 17, 1997
THERMO-STAT SYSTEM
K970367 · DWJ
Aquarius Medical Corp.
Cardiovascular · 320d
Cleared Dec 17, 1997
VASOCOR PVR 100
K973659 · JOM
Vasocor, Inc.
Cardiovascular · 83d
Cleared Dec 16, 1997
T-REX BIOPSY FORCEPS
K973818 · DWZ
Boston Scientific Corp
Cardiovascular · 70d
Cleared Dec 16, 1997
HEARTPORT ENDOAORTIC CLAMP CATHETER
K974175 · DWZ
Heartport, Inc.
Cardiovascular · 40d
Cleared Dec 12, 1997
HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, ACS...
K973494 · DQX
Guidant Corp.
Cardiovascular · 88d
Cleared Dec 11, 1997
FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, PAD2EK-2X,...
K964663 · DXC
Rmds, Inc.
Cardiovascular · 385d
Cleared Dec 11, 1997
IVT 0.014 PTFE-COATED TRACKWIRE
K971688 · DQX
Boston Scientific /International...
Cardiovascular · 218d
Cleared Dec 11, 1997
COURIER ST BALLOON DILATATION CATHETER
K972744 · LIT
Boston Scientific Corp
Cardiovascular · 141d
Cleared Dec 09, 1997
HEART PROTECTOR (VER 1996)
K965158 · DRT
N.P.N.T., Inc.
Cardiovascular · 351d
Cleared Dec 08, 1997
COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR
K963518 · DTZ
Cobe Cardiovascular, Inc.
Cardiovascular · 461d
Cleared Dec 08, 1997
3M CDI H/S CUVETTES WITH HEPARON TREATMENT
K973472 · DRY
3M Healthcare
Cardiovascular · 87d
Cleared Dec 05, 1997
ACIST ANGIOGRAPHIC INJECTOR
K963982 · DXT
Invasatec
Cardiovascular · 429d
Cleared Dec 04, 1997
RHYTHMSTAT XL
K971650 · DXH
Data Critical Corp.
Cardiovascular · 212d
Cleared Dec 04, 1997
CARDIOCALL CARDIAC EVENT RECORDER
K972649 · DXH
Reynolds Medical , Ltd.
Cardiovascular · 142d
Cleared Dec 03, 1997
HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULES
K973437 · DPS
Hewlett-Packard GmbH
Cardiovascular · 84d
Cleared Dec 02, 1997
FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELECTROCARDIOGRAPH
K971440 · LOS
Fukuda Denshi USA, Inc.
Cardiovascular · 228d
Cleared Nov 25, 1997
FAVC-HH: FEMORAL ARTERY VASCULAR CLAMP-HAND HELD: 1/2 & 3 POUNDS...
K973216 · DXC
Rmds, Inc.
Cardiovascular · 90d
Cleared Nov 25, 1997
MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)
K973230 · DXT
Merit Medical Systems, Inc.
Cardiovascular · 90d
Cleared Nov 24, 1997
FLUORO-TEX SURGICAL MEMBRANE
K973178 · DXZ
Bridger Biomed, Inc.
Cardiovascular · 91d
Cleared Nov 24, 1997
CERTODYN RAECG UNIVERSAL ADAPTER
K973371 · DQY
B.Braun Medical, Inc.
Cardiovascular · 77d
Cleared Nov 20, 1997
CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND...
K973475 · DTR
Medtronic Vascular
Cardiovascular · 69d