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
5305–5328 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 09, 2010
MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS
K102723 · MWJ
Memtec Corp.
Cardiovascular · 79d
Cleared Dec 09, 2010
KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K102609 · DXN
Andon Medical Co., Ltd.
Cardiovascular · 90d
Cleared Dec 09, 2010
MULLINS-X PTV CATHETER
K102473 · OMZ
NuMED, Inc.
Cardiovascular · 101d
Cleared Dec 09, 2010
STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM
K101046 · DTX
Sorin Group Deutschland GmbH
Cardiovascular · 239d
Cleared Dec 08, 2010
SEEKER CROSSING SUPPORT CATHETER
K103367 · DQY
Bard Peripheral Vascular, Inc.
Cardiovascular · 22d
Cleared Dec 08, 2010
QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL:...
K101153 · DTZ
Maquet Cardiopulmonary, AG
Cardiovascular · 229d
Cleared Dec 07, 2010
ARMADA 14 PTA CATHETER
K102705 · LIT
Abbott Vascular, Inc.
Cardiovascular · 78d
Cleared Dec 07, 2010
SPACELABS MEDICAL PATIENT MONITORS
K102422 · MHX
Spacelabs Medical, Inc.
Cardiovascular · 104d
Cleared Dec 07, 2010
NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201
K102376 · MHX
Nihon Kohden Corp.
Cardiovascular · 109d
Cleared Dec 07, 2010
MEDICAL MAGNETIC TAPE RECORDER
K102111 · DSI
Wpr Medical AS
Cardiovascular · 132d
Cleared Dec 07, 2010
VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5
K100739 · KRB
Edwards Lifesciences, LLC
Cardiovascular · 266d
Cleared Dec 07, 2010
EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M
K100709 · DXG
Edwards Lifesciences, LLC
Cardiovascular · 270d
Cleared Dec 06, 2010
EVERCROSS 0.035 OTW PTA DILATION CATHETER
K103322 · LIT
Ev3, Inc.
Cardiovascular · 24d
Cleared Dec 03, 2010
PHYSIOFLOW ENDURO
K103283 · DSB
Vasocom, Inc.
Cardiovascular · 28d
Cleared Dec 03, 2010
PC ECG
K102854 · DPS
Edan Instruments, Inc.
Cardiovascular · 65d
Cleared Dec 03, 2010
MICRUS ONE 2 ONE GUIDEWIRE, MICRUS ONE 2 ONE SOFT GUIDEWIRE
K102818 · DQX
Micrus Endovascular Corporation
Cardiovascular · 66d
Cleared Dec 03, 2010
BIOHARNESS
K100040 · MHX
Zephyr Technology Corporation
Cardiovascular · 330d
Cleared Dec 02, 2010
ELECTROCARDIOGRAPH
K102830 · DPS
Edan Instruments, Inc.
Cardiovascular · 64d
Cleared Dec 02, 2010
HYPERQ AD-100 SYSTEM
K102579 · MWI
Biological Signal Processing, Ltd.
Cardiovascular · 85d
Cleared Dec 01, 2010
M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130
K103214 · DRG
Lifeline Systems, Inc.
Cardiovascular · 30d
Cleared Dec 01, 2010
SLEEK OTW PTA CATHETERS
K102035 · LIT
ClearStream Technologies , Ltd.
Cardiovascular · 135d
Cleared Nov 26, 2010
MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX
K101784 · DYB
Great Batch Medical
Cardiovascular · 154d
Cleared Nov 24, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K102690 · DXN
Andon Health Co, Ltd.
Cardiovascular · 68d
Cleared Nov 23, 2010
OMNI EXPRESS
K103268 · MWI
Infinium Medical
Cardiovascular · 19d