FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,053 results
12289–12312 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 26, 1991
ES-1000SP II SMART DOP
K903026 · DPW
Koven and Assoc., Inc.
Cardiovascular · 231d
Cleared Feb 25, 1991
MODIFIED LIFEPAK 9 MONITOR/DEFIBRILLATOR
K902288 · LDD
Physio-Control Corp.
Cardiovascular · 279d
Cleared Feb 25, 1991
EMBOLECTOMY CATHETER
K902327 · DXE
Clincal Instruments Corp.
Cardiovascular · 277d
Cleared Feb 25, 1991
INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH.
K902627 · KRB
Biometric Research Institute, Inc.
Cardiovascular · 257d
Cleared Feb 25, 1991
INTERFLO MEDICAL MODEL INTERFLO/1 CARDIAC OUTPUT
K902628 · DXG
Biometric Research Institute, Inc.
Cardiovascular · 257d
Cleared Feb 25, 1991
MODEL 4222 AMBULATORY ECG MONITOR
K904250 · DXH
Byrncrest Global, Inc.
Cardiovascular · 161d
Cleared Feb 25, 1991
QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE
K904582 · DQX
Meadox Surgimed, Inc.
Cardiovascular · 139d
Cleared Feb 25, 1991
VISTA VIEWING STATION
K904975 · DXK
Prism Imaging, Inc.
Cardiovascular · 116d
Cleared Feb 25, 1991
CINE'VIEW - STRESS ECHO & IMAGE REVIEW
K904976 · DXK
Prism Imaging, Inc.
Cardiovascular · 116d
Cleared Feb 25, 1991
CINE/VIEW PLUS - CARDIOLOGY WORKSTATION
K904977 · DXK
Prism Imaging, Inc.
Cardiovascular · 116d
Cleared Feb 25, 1991
SOFTWARE PROGRAM USED W/PRISM PRODUCTS
K904978 · DXK
Prism Imaging, Inc.
Cardiovascular · 116d
Cleared Feb 25, 1991
CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETER
K905139 · DXE
Cathlab Corp.
Cardiovascular · 108d
Cleared Feb 25, 1991
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY GUIDEWIRE
K905548 · DQX
Mallinckrodt Medical
Cardiovascular · 76d
Cleared Feb 25, 1991
SARNS TEMPERATURE PROBE AND CONNECTOR
K905686 · DWE
3M Health Care, Sarns
Cardiovascular · 68d
Cleared Feb 25, 1991
BIFURCATED VS-1 TO VS-1 LEAD ADAPTOR
K910112 · DTD
Telectronics Pacing Systems, Inc.
Cardiovascular · 46d
Cleared Feb 25, 1991
LP-60 LOW PRESSURE INFLATION DEVICE
K910205 · MAV
Devices For Vascular Intervention, Inc.
Cardiovascular · 40d
Cleared Feb 25, 1991
MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR
K910237 · DTE
Medtronic Vascular
Cardiovascular · 38d
Cleared Feb 22, 1991
ACCENT DG(TM) BALLOON ANGIOPLASTY CATHETER
K900677 · LIT
Cook, Inc.
Cardiovascular · 375d
Cleared Feb 21, 1991
CVIS INSIGHT IMAGING CATHETER
K905625 · DQO
Cardiovascular Imaging Systems, Inc.
Cardiovascular · 69d
Cleared Feb 20, 1991
INTHERM TEMPORARY OCCLUSION CATHETER
K901287 · DYG
Interventional Therapeutics Corp.
Cardiovascular · 337d
Cleared Feb 20, 1991
TORQUE HANDLE DEVICE FOR GUIDEWIRE
K905639 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 65d
Cleared Feb 19, 1991
HP MODEL M1008B, NONINVASIVE BLOOD PRESSURE MODULE
K903771 · DXN
Hewlett-Packard Co.
Cardiovascular · 183d
Cleared Feb 19, 1991
NEW USCI 7F PTCA GUIDING CATHETER
K905249 · DQY
C.R. Bard, Inc.
Cardiovascular · 90d
Cleared Feb 19, 1991
SILICONE COATED GUIDEWIRES
K905581 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 69d