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
7513–7536 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 15, 2004
VST3
K040942 · DXH
Biowatch Medical, Inc.
Cardiovascular · 156d
Cleared Sep 15, 2004
DISPOSABLE MONITORING ELECTRODES
K041954 · DRX
Shanghai Intco Electrode...
Cardiovascular · 57d
Cleared Sep 15, 2004
SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA)
K042020 · MUD
Hutchinson Technology, Inc.
Cardiovascular · 50d
Cleared Sep 15, 2004
ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY
K042194 · DQY
Medtronic Vascular
Cardiovascular · 34d
Cleared Sep 14, 2004
PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20
K040479 · MKJ
Welch Allyn, Inc.
Cardiovascular · 202d
Cleared Sep 14, 2004
EP-4 CLINICAL STIMUTATOR
K041442 · JOQ
Ep Medsystems
Cardiovascular · 105d
Cleared Sep 14, 2004
MODIFICATION TO EPTFE GRAFT
K041528 · DSY
Vascutek, Ltd.
Cardiovascular · 98d
Cleared Sep 14, 2004
ZOE FLUID STATUS MONITOR
K042113 · DSB
Noninvasive Medical Technologies, LLC
Cardiovascular · 40d
Cleared Sep 08, 2004
X-SIZER CATHETER SYSTEM
K021096 · MCW
Ev3 Corporation
Cardiovascular · 888d
Cleared Sep 08, 2004
MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC)
K042128 · DQD
Zargis Medical Corp.
Cardiovascular · 33d
Cleared Sep 07, 2004
SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21
K041883 · MKJ
Leonhard Lang GmbH
Cardiovascular · 57d
Cleared Sep 07, 2004
MODEL 6416 TEMPORARY PACING LEAD SYSTEM
K042190 · LDF
Medtronic Vascular
Cardiovascular · 26d
Cleared Sep 02, 2004
DETECT SURGICAL PACING AND MAPPING TOOL
K040812 · LDF
Medtronic Vascular
Cardiovascular · 157d
Cleared Sep 02, 2004
MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260
K041979 · DTR
Quest Medical, Inc.
Cardiovascular · 41d
Cleared Sep 02, 2004
SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301
K042088 · MKJ
Heartsine Technologies, Inc.
Cardiovascular · 30d
Cleared Sep 02, 2004
ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO...
K042187 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 21d
Cleared Sep 01, 2004
RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2
K041705 · QEY
Omnisonics Medical Technologies
Cardiovascular · 70d
Cleared Aug 31, 2004
LIFECLINIC, MODEL 2400
K040562 · DXN
Lifeclinic International, Inc.
Cardiovascular · 181d
Cleared Aug 31, 2004
REIZEN TALKING BLOOD PRESSURE MONITOR, MODEL #SF860T
K041778 · DXN
Maxi-Aids, Inc.
Cardiovascular · 61d
Cleared Aug 31, 2004
SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER
K041901 · MWJ
North East Monitoring, Inc.
Cardiovascular · 48d
Cleared Aug 31, 2004
ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM
K042218 · NTE
Guidant Corp.
Cardiovascular · 26d
Cleared Aug 31, 2004
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR MODEL# HL888
K042265 · DXN
Health & Life Co., Ltd.
Cardiovascular · 8d
Cleared Aug 31, 2004
MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY
K042273 · DXN
Health Hero Network, Inc.
Cardiovascular · 8d
Cleared Aug 27, 2004
MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
K042177 · DPS
Ge Medical Systems Information...
Cardiovascular · 16d