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
8977–9000 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 06, 2000
MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE)
K003483 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 27d
Cleared Dec 05, 2000
SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS
K002105 · MLD
Siemens Medical Solutions USA, Inc.
Cardiovascular · 146d
Cleared Dec 01, 2000
TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107
K003276 · LIT
NuMED, Inc.
Cardiovascular · 43d
Cleared Dec 01, 2000
WIRECLIP TORQUER
K003398 · DQX
Boston Scientific Corporation...
Cardiovascular · 30d
Cleared Nov 30, 2000
DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION)...
K002493 · DTM
Cobe Cardiovascular, Inc.
Cardiovascular · 108d
Cleared Nov 30, 2000
NICOLET VASOGUARD
K002766 · JOP
Nicolet Biomedical
Cardiovascular · 86d
Cleared Nov 29, 2000
ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509
K000004 · DYB
Daig Corp.
Cardiovascular · 331d
Cleared Nov 29, 2000
MEDICAL CABLES PATIENT MONITORING CABLES FOR ECG, EEG, SPO2, AND BLOOD...
K002781 · DSA
Medical Cables, Inc.
Cardiovascular · 84d
Cleared Nov 22, 2000
PC ECG 1200
K000404 · MWI
Norav Medical , Ltd.
Cardiovascular · 289d
Cleared Nov 22, 2000
ALPHA OMEGA DUAL COOLER-HEATER
K001520 · DWC
Alpha Omega, Inc.
Cardiovascular · 190d
Cleared Nov 22, 2000
DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL...
K002047 · DQD
Doctor'S Research Group, Inc.
Cardiovascular · 139d
Cleared Nov 21, 2000
ROSETTA-LT/ROSETTA-RX
K002089 · DRG
General Devices
Cardiovascular · 133d
Cleared Nov 21, 2000
MICROPAQ, MODELS 402 AND 404
K002725 · DRT
Protocol Systems, Inc.
Cardiovascular · 82d
Cleared Nov 21, 2000
K-DEFIB/PACE, MODEL KDP-60A
K002806 · MKJ
Katecho, Inc.
Cardiovascular · 74d
Cleared Nov 21, 2000
PINNACLE R/O II OR RADIFOCUS INTRODUCER II
K003424 · DYB
Terumo Medical Corp.
Cardiovascular · 18d
Cleared Nov 21, 2000
MODEL WS-500 DIGITAL WRIST BLOOD PRESSURE MONITOR
K003444 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 15d
Cleared Nov 17, 2000
TISSUE SPECTROSCOPE
K992529 · DPW
Vital Medical , Ltd.
Cardiovascular · 478d
Cleared Nov 16, 2000
FRONT-LOAD POLYPROPYLENE SYRINGE
K001663 · DXT
Medrad, Inc.
Cardiovascular · 169d
Cleared Nov 14, 2000
WELCH ALLYN SPOT CHECK DEVICE
K002530 · DXN
Welch Allyn, Inc.
Cardiovascular · 90d
Cleared Nov 13, 2000
ALLON 2001 MODIFIED
K003349 · DWJ
Mtre Advanced Technology , Ltd.
Cardiovascular · 18d
Cleared Nov 09, 2000
ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3
K002687 · LDF
Zynergy Cardiovascular, Inc.
Cardiovascular · 72d
Cleared Nov 09, 2000
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM
K003179 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 29d
Cleared Nov 08, 2000
PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH
K002459 · DPS
Agilent Technologies, Inc.
Cardiovascular · 90d
Cleared Nov 08, 2000
WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES
K002473 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 89d