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
6097–6120 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 26, 2008
LEVITRONIX CENTRIMAG PRIMARY CONSOLE
K083340 · DWA
Levitronix, LLC
Cardiovascular · 14d
Cleared Nov 26, 2008
CARDIO-VIEW
K083321 · DXJ
Curlview Igt, LLC
Cardiovascular · 15d
Cleared Nov 26, 2008
MODIFICATION TO INTEL HEALTH GUIDE, MODEL PHS6000
K083115 · DRG
Intel Corp.
Cardiovascular · 36d
Cleared Nov 26, 2008
QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200
K083078 · DXN
Quanta Computer, Inc.
Cardiovascular · 41d
Cleared Nov 26, 2008
NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES
K082785 · MHX
Nihon Kohden America, Inc.
Cardiovascular · 64d
Cleared Nov 25, 2008
VIPERSPHERE PTA BALLOON CATHETER
K083139 · DQY
Cardiovascular Systems, Inc.
Cardiovascular · 33d
Cleared Nov 25, 2008
AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561
K082861 · MKJ
Amco International Manufacturing &...
Cardiovascular · 57d
Cleared Nov 24, 2008
PHILIPS INTELLIVUE MP5 PATIENT MONITOR
K083228 · MHX
Philips Medizin Systeme Boblingen GmbH
Cardiovascular · 21d
Cleared Nov 24, 2008
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP O3
K082881 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 56d
Cleared Nov 21, 2008
ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000
K083146 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 29d
Cleared Nov 21, 2008
NEURON SELECT CATHETER SIZE 070
K083125 · DQY
Penumbra, Inc.
Cardiovascular · 30d
Cleared Nov 20, 2008
EVERCROSS .035 OTW PTA DILATATION CATHETER
K082579 · DQY
Ev3, Inc.
Cardiovascular · 76d
Cleared Nov 20, 2008
ENABLER-P SUPPORT CATHETER
K082339 · DQY
Endocross, Ltd.
Cardiovascular · 98d
Cleared Nov 19, 2008
MULTLINK CABLE AND LEADWIRE SYSTEM
K082851 · DSA
Ge Medical Systems Information...
Cardiovascular · 51d
Cleared Nov 18, 2008
FIBERNET EMBOLIC PROTECTION SYSTEM
K082348 · NTE
Lumen Biomedical, Inc.
Cardiovascular · 95d
Cleared Nov 18, 2008
AVALON ELITE VASCULAR ACCESS KIT
K081940 · DRE
Avalon Laboratories, LLC
Cardiovascular · 133d
Cleared Nov 14, 2008
SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE
K081986 · DRC
Oscor, Inc.
Cardiovascular · 123d
Cleared Nov 13, 2008
A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR
K082734 · DXN
A&D Engineering, Inc.
Cardiovascular · 56d
Cleared Nov 10, 2008
VENOUS BUBBLE TRAP, MODEL VBT 160
K082412 · DTP
Mapquet Cardiopulmonary AG
Cardiovascular · 81d
Cleared Nov 10, 2008
CLUE MEDICAL AND CLUE MEDICAL BASIC
K082013 · DPS
Telovital GmbH Telemedizin
Cardiovascular · 118d
Cleared Nov 07, 2008
TELECTRODE WET GEL ECG ELECTRODE
K083148 · DRX
Bio Protech, Inc.
Cardiovascular · 14d
Cleared Nov 07, 2008
REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC...
K082475 · DSI
Medtronic, Inc.
Cardiovascular · 71d
Cleared Nov 06, 2008
AGILIS NXT STEERABLE INTRODUCER
K083083 · DYB
St Jude Medical
Cardiovascular · 21d
Cleared Nov 03, 2008
PASSEO-35 PTA CATHETER
K082933 · DQY
Biotronik, Inc.
Cardiovascular · 33d