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
5617–5640 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 12, 2010
FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE
K093192 · JOM
Advanced Vascular Dynamics
Cardiovascular · 126d
Cleared Feb 12, 2010
IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING
K093004 · DQO
Merit Medical Systems, Inc.
Cardiovascular · 137d
Cleared Feb 05, 2010
AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120,...
K093476 · DQY
Aga Medical Corp.
Cardiovascular · 88d
Cleared Feb 04, 2010
OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER
K091077 · DTK
Cordis Corp., A Johnson & Johnson Co.
Cardiovascular · 296d
Cleared Feb 02, 2010
HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER,...
K100063 · MJN
Ev3, Inc.
Cardiovascular · 22d
Cleared Feb 02, 2010
GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H
K092970 · MHX
General Meditech, Inc.
Cardiovascular · 130d
Cleared Jan 29, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-557
K100014 · DXN
Andon Health Co, Ltd.
Cardiovascular · 25d
Cleared Jan 29, 2010
URSA ANGIOGRAPHIC CATHETER
K090427 · DQO
Curative Medical Technology, Inc.
Cardiovascular · 344d
Cleared Jan 28, 2010
DOCKING STATION,TEIRSTEIN EDGE,ANGIOASSIST COMBINATION DEVICE, ANGIOASSIST...
K093822 · DQX
Shepherd Scientific, Inc.
Cardiovascular · 45d
Cleared Jan 26, 2010
MERIDIAN GUIDEWIRE
K093681 · DQX
Ev3 Neurovascular
Cardiovascular · 60d
Cleared Jan 25, 2010
TURBO-TANDEM SYSTEM MODEL 472-110
K094036 · MCW
Spectranetics Corp.
Cardiovascular · 26d
Cleared Jan 25, 2010
U-RIGHT TD-3132 BLOOD PRESSURE MONITOR, FORA P 20 BLOOD PRESSURE MONITOR,...
K092106 · DXN
Taidoc Technology Corporation
Cardiovascular · 195d
Cleared Jan 22, 2010
AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS
K093986 · DTM
Sorin Group Italia S.R.L.
Cardiovascular · 29d
Cleared Jan 22, 2010
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888V, FULL AUTOMATIC...
K093823 · DXN
Health & Life Co., Ltd.
Cardiovascular · 39d
Cleared Jan 21, 2010
JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD)
K093918 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 30d
Cleared Jan 21, 2010
FOGARTY OCCLUSION CATHETER
K093911 · MJN
Edwards Lifesciences, LLC
Cardiovascular · 30d
Cleared Jan 21, 2010
ODYSSEY WORKSTATION
K093092 · DQK
Stereotaxis, Inc.
Cardiovascular · 112d
Cleared Jan 20, 2010
QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000)
K093172 · DPS
Dynacardia, Inc.
Cardiovascular · 104d
Cleared Jan 20, 2010
THE PICC WAND PEELABLE SAFETY INTRODUCER
K093022 · DYB
Access Scientific, Inc.
Cardiovascular · 113d
Cleared Jan 19, 2010
CEROX MODEL 3210
K093923 · MUD
Or-Nim Medical , Ltd.
Cardiovascular · 28d
Cleared Jan 15, 2010
PICA CATHETER
K093970 · LIT
Penumbra, Inc.
Cardiovascular · 23d
Cleared Jan 15, 2010
SORIN C5 SYSTEM MODEL 58-00-00
K093882 · DTQ
Sorin Group Deutschland GmbH
Cardiovascular · 28d
Cleared Jan 15, 2010
ADAGIO RETRACTING ECG LEAD WIRES
K093657 · DSA
Acist Medical Systems, Inc.
Cardiovascular · 51d
Cleared Jan 14, 2010
PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24)
K093730 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 42d