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
5785–5808 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 04, 2009
TRULY AUTOMATIC ARM BLOOD PRESSURE...
K091434 · DXN
Truly Instrument Co., Ltd.
Cardiovascular · 114d
Cleared Sep 04, 2009
TRULY AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODEL DW100,DW200,...
K091415 · DXN
Truly Instrument Co., Ltd.
Cardiovascular · 114d
Cleared Sep 04, 2009
CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS...
K090898 · DRF
Biosense Webster, Inc.
Cardiovascular · 156d
Cleared Sep 03, 2009
JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD).,...
K092332 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 30d
Cleared Sep 02, 2009
BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000
K091841 · DQY
Bridgepoint Medical
Cardiovascular · 72d
Cleared Sep 01, 2009
QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH
K090496 · DRX
Cardiac Lead Technologies, Inc.
Cardiovascular · 188d
Cleared Sep 01, 2009
VALVED TEARWAY INTRODUCER
K090394 · DYB
Medcomp
Cardiovascular · 196d
Cleared Aug 31, 2009
VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS
K091778 · DSY
Vascutek, Ltd.
Cardiovascular · 75d
Cleared Aug 28, 2009
VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT
K092486 · DWE
Vortex Medical, Inc.
Cardiovascular · 15d
Cleared Aug 28, 2009
CARESCAPE MONITOR B850
K092027 · MHX
Ge Medical Systems Information...
Cardiovascular · 53d
Cleared Aug 27, 2009
SEGUIN ANNULOPLASTY RING
K092310 · KRH
St Jude Medical
Cardiovascular · 29d
Cleared Aug 27, 2009
FOX SV PTA CATHETER
K092286 · LIT
Abbott Vascular
Cardiovascular · 29d
Cleared Aug 27, 2009
AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT)...
K091971 · DSI
Corventis, Inc.
Cardiovascular · 57d
Cleared Aug 27, 2009
MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL...
K090869 · DWF
Medtronic Perfusion Systems
Cardiovascular · 149d
Cleared Aug 26, 2009
EKG-PLUS II SOFTWARE
K090895 · LOS
Bionet Co., Ltd.
Cardiovascular · 149d
Cleared Aug 25, 2009
BLOOD PRESSURE MONITOR, MODEL FORA P11/TD-3019
K091897 · DXN
Taidoc Technology Corporation
Cardiovascular · 62d
Cleared Aug 25, 2009
COMMANDER 111, MODEL CD300-CD399
K091821 · DXN
Cardiocom, LLC
Cardiovascular · 68d
Cleared Aug 25, 2009
SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A
K090936 · DPS
Contec Medical System Co., Ltd.
Cardiovascular · 145d
Cleared Aug 21, 2009
SKINTACT AND VARIOUS OTHER TRADENAMES
K092291 · DRX
Leonhard Lang GmbH
Cardiovascular · 23d
Cleared Aug 21, 2009
FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030)
K091452 · MUD
Cas Medical Systems, Inc.
Cardiovascular · 95d
Cleared Aug 21, 2009
CARE PAL, MODEL CPW-10X
K091430 · DRG
Digio2 International Co., Ltd.
Cardiovascular · 99d
Cleared Aug 20, 2009
TERUMO PALL AL3X ARTERIAL FILTER
K083747 · DTM
Terumo Cardiovascular Systems Corp.
Cardiovascular · 246d
Cleared Aug 18, 2009
SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-3917, KD 3909
K091739 · DXN
Andon Health Co, Ltd.
Cardiovascular · 68d
Cleared Aug 18, 2009
SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-388BD
K091738 · DXN
Andon Health Co, Ltd.
Cardiovascular · 68d