FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,027 results
10897–10920 of 18,027
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 22, 1995
INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS)
K941762 · DQK
Hogan & Hartson
Cardiovascular · 317d
Cleared Feb 22, 1995
CVPRO CARDIOVASCULAR PATCH
K943736 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 204d
Cleared Feb 21, 1995
INTRODUCER NEEDLE (SEVERAL SIZES)
K933522 · DYB
Mediziv Medical Products 1987 , Ltd.
Cardiovascular · 581d
Cleared Feb 17, 1995
MEDSAT OXYGEN SATURATION SYSTEM
K941922 · DRY
Medtronic Bio-Medicus, Inc.
Cardiovascular · 303d
Cleared Feb 15, 1995
PANASONIC WRIST BLOOD PRESSURE METER
K942422 · DXN
King & Spalding
Cardiovascular · 271d
Cleared Feb 15, 1995
NAIS WRIST BLOOD PRESSURE METER
K942423 · DXN
King & Spalding
Cardiovascular · 271d
Cleared Feb 10, 1995
REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WITH HYDROMER COATING
K935184 · DSP
St. Jude Medical, Inc.
Cardiovascular · 472d
Cleared Feb 10, 1995
ZOLL POWERBASE(TM)
K942850 · MKJ
Zoll Medical Corp
Cardiovascular · 239d
Cleared Feb 10, 1995
MONARCH AP(TM)
K943597 · MAV
Merit Medical Systems, Inc.
Cardiovascular · 202d
Cleared Feb 10, 1995
BAXTER HANDLE MODEL 1150
K944214 · DTJ
Baxter Edwards
Cardiovascular · 165d
Cleared Feb 10, 1995
APPLIED MEDICAL OPTICAL VALVULOTOME
K945591 · LYK
Applied Medical Resources
Cardiovascular · 88d
Cleared Feb 09, 1995
VIVALINK AED DEFIBRILLATOR
K940445 · MKJ
Survivalink Corp.
Cardiovascular · 373d
Cleared Feb 08, 1995
SCIMED TRANSENT EX STEERABLE GUIDE WIRE AND ACCESSORIES
K944677 · DQX
Scimed Peripheral Interventions
Cardiovascular · 139d
Cleared Feb 08, 1995
THE OMNIGUIDE GUIDING CATHETER WITH BALLOON
K945963 · DQT
Micro Interventional Systems, Inc.
Cardiovascular · 63d
Cleared Feb 07, 1995
GRAFT THROMBECTOMY INSTRUMENTS
K942457 · MCW
Intramed Laboratories, Inc.
Cardiovascular · 259d
Cleared Feb 03, 1995
QUIK COMBO
K943301 · DRX
Physio-Control Corp.
Cardiovascular · 210d
Cleared Feb 03, 1995
PITON(TM) Y-PACK AND PITON(TM) TRI-PACK)
K945461 · DTL
Medtronics Interventional Vascular
Cardiovascular · 88d
Cleared Feb 03, 1995
5F ENVOY(TM) GUIDING CATHETER
K945705 · DQY
Cordis Neurovascular, Inc.
Cardiovascular · 87d
Cleared Feb 01, 1995
VASOTRAC BLOOD PRESSURE MONITOR, MODEL - APM 205
K950249 · DXN
Medwave, Inc.
Cardiovascular · 12d
Cleared Jan 31, 1995
VITALMAX 800 PLUS/VITALMAX 810 PLUS/MINIPACK 300
K945385 · MHX
Pace Tech, Inc.
Cardiovascular · 89d
Cleared Jan 30, 1995
PACIFIC COMMUNICATIONS MODEL 1100
K942147 · DSI
Accucore, Inc.
Cardiovascular · 272d
Cleared Jan 30, 1995
HEWLETT-PACKARD MODEL M1490A WIRELESS PATIENT DATA COMMUNICATOR
K945277 · DXJ
Hewlett-Packard Co.
Cardiovascular · 94d
Cleared Jan 27, 1995
CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER
K942546 · DXN
Dynatech/Nevada, Inc.
Cardiovascular · 241d
Cleared Jan 27, 1995
SORIN BLOOD CARDIOPLEGIA CONSOLE
K942582 · DTQ
Sorin Biomedical, Inc.
Cardiovascular · 240d