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
5449–5472 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 21, 2010
VISCOPE, MODEL 100P,100S
K100531 · DQD
Hd Medical Services (India) Pvt.Ltd
Cardiovascular · 147d
Cleared Jul 19, 2010
COHEN CROSSOVER CATHETER
K101625 · DQO
Vascular Solutions, Inc.
Cardiovascular · 40d
Cleared Jul 16, 2010
LEV-OR DILATION CATHETER OTW
K101117 · DQY
Baylis Medical Co., Inc.
Cardiovascular · 86d
Cleared Jul 16, 2010
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000
K101092 · DWJ
Medivance, Inc.
Cardiovascular · 87d
Cleared Jul 16, 2010
REPROCESSED RESTEP COMPRESSION SLEEVES
K101087 · JOW
Ascent Heatlhcare Solutions
Cardiovascular · 88d
Cleared Jul 15, 2010
ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC
K093903 · KRH
Genesee Biomedical, Inc.
Cardiovascular · 205d
Cleared Jul 14, 2010
ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY
K101735 · PNO
Angioscore, Inc.
Cardiovascular · 23d
Cleared Jul 14, 2010
ENSITE VELOCITY SYSTEM
K101328 · DQK
St Jude Medical
Cardiovascular · 64d
Cleared Jul 13, 2010
MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA...
K101703 · DSI
Card Guard Scientific Survival , Ltd.
Cardiovascular · 26d
Cleared Jul 13, 2010
HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS
K101570 · MJN
Micro Therapeutics Dba Ev3 Neurovascular
Cardiovascular · 39d
Cleared Jul 13, 2010
PTA-DUO PTA BALLOON CATHETER
K101047 · LIT
Hotspur Technologies
Cardiovascular · 90d
Cleared Jul 13, 2010
PENUMBRA CATHERER 025
K100826 · DQY
Penumbra, Inc.
Cardiovascular · 111d
Cleared Jul 12, 2010
PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM
K100842 · DXE
Hotspur Technologies
Cardiovascular · 109d
Cleared Jul 12, 2010
EMBO PLUS EMBOLECTOMY CATHETER
K100840 · DXE
Hotspur Technologies
Cardiovascular · 110d
Cleared Jul 09, 2010
WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES
K101680 · DXN
Welch Allyn, Inc.
Cardiovascular · 24d
Cleared Jul 09, 2010
ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE
K101651 · NTE
Cordis Corp.
Cardiovascular · 28d
Cleared Jul 09, 2010
PULMOTRACK 5050 WHOLTER, MODEL 5050
K101022 · DSH
Karmelsonix
Cardiovascular · 87d
Cleared Jul 09, 2010
MD2000B VITAL SIGN MONITOR, MODEL MD2000B
K100740 · MWI
Beijing Choice Electronic Technololgy...
Cardiovascular · 115d
Cleared Jul 09, 2010
U-RIGHT TD-3127 BLOOD PRESSURE MONITORING SYSTEM
K100658 · DXN
Taidoc Technology Corporation
Cardiovascular · 123d
Cleared Jul 09, 2010
3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM
K092853 · MLO
Galix Biomedical Instrumentation, Inc.
Cardiovascular · 296d
Cleared Jul 08, 2010
HI-TORQUE WINN GUIDE WIRE FAMILY
K101648 · DQX
Abbott Vascular, Inc.
Cardiovascular · 27d
Cleared Jul 08, 2010
IMPELLA CONTROLLER
K093801 · KFM
Abiomed, Inc.
Cardiovascular · 210d
Cleared Jul 07, 2010
XYLOS VESSEL GUARD
K100984 · OMR
Xylos Corporation
Cardiovascular · 90d
Cleared Jul 02, 2010
MISTRAL-AIR WARMING SYSTEM
K101705 · DWJ
The Surgical Company International B.V.
Cardiovascular · 15d