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
6025–6048 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 29, 2009
FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7906
K083247 · DXN
Andon Health Co, Ltd.
Cardiovascular · 87d
Cleared Jan 29, 2009
FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5961
K083246 · DXN
Andon Health Co, Ltd.
Cardiovascular · 87d
Cleared Jan 29, 2009
I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE...
K073593 · DPT
Deltex Medical Limited
Cardiovascular · 405d
Cleared Jan 28, 2009
GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951
K081846 · DQO
Vascular Solutions, Inc.
Cardiovascular · 212d
Cleared Jan 27, 2009
LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM
K081878 · DQY
LeMaitre Vascular, Inc.
Cardiovascular · 209d
Cleared Jan 26, 2009
GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING
K081838 · DTR
Gish Biomedical, Inc.
Cardiovascular · 210d
Cleared Jan 23, 2009
ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR
K083835 · KRH
St Jude Medical
Cardiovascular · 31d
Cleared Jan 23, 2009
JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300
K083489 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 59d
Cleared Jan 23, 2009
CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200
K083470 · KRH
Edwards Lifesciences, LLC
Cardiovascular · 60d
Cleared Jan 23, 2009
GISH TUBING AND CONNECTORS WITH HA COATING
K081881 · DWF
Gish Biomedical, Inc.
Cardiovascular · 205d
Cleared Jan 22, 2009
SYRINGE WITH HANDI-FIL
K082212 · DXT
Mallinckrodt Inc., Liebel-Flarsheim...
Cardiovascular · 169d
Cleared Jan 16, 2009
BIOLAND BLOOD PRESSURE MONITOR
K083681 · DXN
Bioland Technology, Ltd.
Cardiovascular · 35d
Cleared Jan 16, 2009
INTELLIVUE PATIENT MONITOR, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MO60,...
K083517 · DSI
Philips Medizinsysteme Boeblingen...
Cardiovascular · 51d
Cleared Jan 16, 2009
FORA TELEHEALTH SYSTEM
K083046 · DRG
Taidoc Technology Corporation
Cardiovascular · 94d
Cleared Jan 16, 2009
PM-1000F+PATIENT MONITOR
K082887 · MWI
Advanced Instrumentations, Inc.
Cardiovascular · 108d
Cleared Jan 16, 2009
PAM 3000
K082626 · DRT
Wireless 2000 RF & Uwb Technologies ,...
Cardiovascular · 129d
Cleared Jan 16, 2009
HEALTH MANAGER, VERSION 1.1
K081499 · DRG
Biocomfort Diagnostics GmbH & Co. KG
Cardiovascular · 232d
Cleared Jan 15, 2009
LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES
K090004 · DWA
Levitronix, LLC
Cardiovascular · 13d
Cleared Jan 15, 2009
MINNIE SUPPORT CATHETER
K082337 · DQY
Vascular Solutions, Inc.
Cardiovascular · 154d
Cleared Jan 15, 2009
GISH ARTERIAL FILTER WITH HA COATING
K081054 · DTM
Gish Biomedical, Inc.
Cardiovascular · 276d
Cleared Jan 13, 2009
JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD)
K083837 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 21d
Cleared Jan 13, 2009
OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120
K083814 · PDU
Cordis Corp., A Johnson & Johnson Co.
Cardiovascular · 22d
Cleared Jan 12, 2009
ASAHI GUIDE WIRE EXTENSION, MODEL AG149000
K083145 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 81d
Cleared Jan 12, 2009
MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC
K082905 · DXT
Medrad, Inc.
Cardiovascular · 104d