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
5881–5904 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 05, 2009
STAR 55 MODEL 100
K090172 · MHX
Larsen & Toubro Limited
Cardiovascular · 133d
Cleared Jun 05, 2009
MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM
K083862 · DRG
Medapps, Inc.
Cardiovascular · 158d
Cleared Jun 04, 2009
FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5903, KD-5909
K090772 · DXN
Andon Health Co, Ltd.
Cardiovascular · 73d
Cleared Jun 04, 2009
FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL, KD-5962
K090771 · DXN
Andon Health Co, Ltd.
Cardiovascular · 73d
Cleared Jun 04, 2009
FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5905
K090770 · DXN
Andon Health Co, Ltd.
Cardiovascular · 73d
Cleared Jun 04, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7961
K090769 · DXN
Andon Health Co, Ltd.
Cardiovascular · 73d
Cleared Jun 04, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD 5901, KD-7909,
K090768 · DXN
Andon Health Co, Ltd.
Cardiovascular · 73d
Cleared Jun 04, 2009
MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S
K090114 · DYB
Oscor, Inc.
Cardiovascular · 134d
Cleared Jun 04, 2009
OPTION VENA CAVA FILTER
K081410 · DTK
Rex Medical
Cardiovascular · 380d
Cleared Jun 03, 2009
SE-601 SERIES ELECTROCARDIOGRAPH
K090367 · DPS
Edan Instruments, Inc.
Cardiovascular · 110d
Cleared Jun 03, 2009
LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL...
K083336 · DWJ
Smiths Medical Asd, Inc.
Cardiovascular · 203d
Cleared May 29, 2009
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K091329 · DYB
Terumo Medical Corp.
Cardiovascular · 24d
Cleared May 29, 2009
THE CROSSER 14 OTW CATHETER, MODEL CRU014
K091254 · DQY
Flowcardia, Inc.
Cardiovascular · 30d
Cleared May 29, 2009
ISOFLOW INFUSION CATHETER
K081147 · KRA
Vascular Designs, Inc.
Cardiovascular · 402d
Cleared May 28, 2009
ECSCOPE 100
K091358 · DPS
Dyansys, Inc.
Cardiovascular · 20d
Cleared May 28, 2009
CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS
K090602 · DSB
Cardiodynamics International Corp.
Cardiovascular · 84d
Cleared May 27, 2009
506CN PATIENT MONITOR
K091050 · DRT
Criticare Systems, Inc.
Cardiovascular · 44d
Cleared May 22, 2009
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19
K090665 · NTE
Abbott Vascular-Vascular Solutions
Cardiovascular · 70d
Cleared May 22, 2009
MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG
K090037 · DSI
Medicalgorithmics SP Z.O.O.
Cardiovascular · 136d
Cleared May 22, 2009
ENABLER-P CATHETER, 1000 PART NUMBER:1160
K083833 · DQY
Endocross, Ltd.
Cardiovascular · 150d
Cleared May 22, 2009
ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010
K083328 · DQK
St Jude Medical
Cardiovascular · 191d
Cleared May 18, 2009
SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL...
K091206 · MXC
Transoma Medical
Cardiovascular · 24d
Cleared May 15, 2009
MODIFICATION TO THE CROSSER SYSTEM
K091119 · PDU
Flowcardia, Inc.
Cardiovascular · 28d
Cleared May 15, 2009
EPICARDIA 5000
K090834 · DSI
Medicomp, Inc.
Cardiovascular · 49d