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
7201–7224 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 26, 2005
PHILIPS 12-LEAD ALGORITHM
K052049 · DPS
Philips Medical Systems
Cardiovascular · 28d
Cleared Aug 25, 2005
ASAHI PTCA GUIDE WIRE FIELDER
K052022 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 30d
Cleared Aug 25, 2005
ATB ADVANCE PTA DILATATION CATHETER
K052036 · DQY
Cook, Inc.
Cardiovascular · 28d
Cleared Aug 24, 2005
H12+ HOLTER RECORDER
K050896 · DSH
Mortara Instrument, Inc.
Cardiovascular · 138d
Cleared Aug 23, 2005
PC COMPATIBLE BLOOD PRESSURE MONITOR, MODEL AK-4000TU, BP-410U, BP-410R
K051862 · DXN
Ya Horng Electronic Co., Ltd.
Cardiovascular · 46d
Cleared Aug 23, 2005
BARD ATLAS PTA BALLOON DILATATION CATHETER
K052236 · DQY
Bard Peripheral Vascular, Inc.
Cardiovascular · 6d
Cleared Aug 19, 2005
AMLUCK, YA HORNG
K051863 · DXN
Ya Horng Electronic Co., Ltd.
Cardiovascular · 42d
Cleared Aug 19, 2005
CARDIONAVIGATOR +
K051960 · DXH
Del Mar Reynolds Medical, Ltd.
Cardiovascular · 31d
Cleared Aug 18, 2005
2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011
K043465 · PDU
Spectranetics Corp.
Cardiovascular · 246d
Cleared Aug 18, 2005
MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM
K052166 · NTE
Guidant Corporation
Cardiovascular · 9d
Cleared Aug 16, 2005
PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM
K052038 · LIT
Boston Scientific Corporation
Cardiovascular · 19d
Cleared Aug 16, 2005
LYSUS INFUSION SYSTEM
K052071 · QEY
Ekos Corp.
Cardiovascular · 15d
Cleared Aug 16, 2005
RX ACCUNET EMBOLIC PROTECTION SYSTEM
K052165 · NTE
Guidant Corporation
Cardiovascular · 7d
Cleared Aug 12, 2005
506 PATIENT MONITOR
K051038 · DRT
Ciriticare Systems, Inc.
Cardiovascular · 109d
Cleared Aug 12, 2005
GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING
K051606 · DTN
Gish Biomedical, Inc.
Cardiovascular · 57d
Cleared Aug 12, 2005
CLEVER TD-3018A BLOOD PRESSURE MONITOR
K051703 · DXN
Taidoc Technology Corporation
Cardiovascular · 49d
Cleared Aug 12, 2005
TRIO MONITOR
K051897 · MWI
Datascope Corp.
Cardiovascular · 30d
Cleared Aug 09, 2005
BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM
K051368 · DXN
Schiller AG
Cardiovascular · 76d
Cleared Aug 08, 2005
VASCULAR SOLUTIONS PRONTO SHORT EXTRACTION CATHETER
K051193 · QEZ
Vascular Solutions, Inc.
Cardiovascular · 90d
Cleared Aug 08, 2005
DIVER C.E. CATHETER
K051917 · QEZ
Invatec Innovative Technologies, S.R.L.
Cardiovascular · 24d
Cleared Aug 05, 2005
METRICATH GEMINI-P BALLOON CATHETER, MODELS RX2515S-P, RX3015S-P, RX3515S-P,...
K051042 · LIT
Angiometrx, Inc.
Cardiovascular · 102d
Cleared Aug 05, 2005
TRICOT BLOOD PRESSURE CUFF
K051539 · DXQ
Ya Horng Electronic Co., Ltd.
Cardiovascular · 56d
Cleared Aug 05, 2005
7F SHERPA NX GUIDE CATHETER
K051846 · DQY
Medtronic Vascular
Cardiovascular · 29d
Cleared Aug 05, 2005
POLAR CATH PERIPHERAL DILATATION SYSTEM
K051916 · LIT
Cryo Vascular Systems, Inc.
Cardiovascular · 21d