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
8449–8472 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 05, 2002
NETLINK/NETSCAN
K020213 · DXH
Rozinn Electronics, Inc.
Cardiovascular · 73d
Cleared Apr 05, 2002
HL168F
K020766 · DXN
Health & Life Co., Ltd.
Cardiovascular · 28d
Cleared Apr 05, 2002
KING OF HEARTS EXPRESS + AF MONITOR
K020825 · DSH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 22d
Cleared Apr 04, 2002
APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
K020997 · DTZ
Dideco S.P.A.
Cardiovascular · 7d
Cleared Apr 04, 2002
SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X
K020998 · KFM
Terumo Cardiovascular Systems Corp.
Cardiovascular · 7d
Cleared Apr 03, 2002
SAFE-STEER GUIDE WIRE SYSTEM
K011986 · DQX
Intra Luminal Therapeutics, Inc.
Cardiovascular · 281d
Cleared Apr 03, 2002
ADVANTA SST BIFURCATED GRAFT
K020767 · DSY
Atrium Medical Corp.
Cardiovascular · 26d
Cleared Mar 28, 2002
THE HAMMER MODEL H100
K012041 · DXC
Tenacore Holdings, Inc.
Cardiovascular · 272d
Cleared Mar 28, 2002
PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB
K020669 · DTB
Oscor, Inc.
Cardiovascular · 27d
Cleared Mar 27, 2002
GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E
K012520 · DRF
Cardiac Assist Devices, Inc.
Cardiovascular · 233d
Cleared Mar 27, 2002
WIZAIR DVT
K012994 · JOW
Medical Compression Systems (Dbn) , Ltd.
Cardiovascular · 202d
Cleared Mar 27, 2002
PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS
K020680 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 23d
Cleared Mar 26, 2002
FLOWTRON UNIVERSAL, MODEL AC600
K010744 · JOW
Huntleigh Healthcare, Inc.
Cardiovascular · 378d
Cleared Mar 26, 2002
COSMED QUARK C12/QUARK T12
K014262 · DPS
Cosmed Srl
Cardiovascular · 89d
Cleared Mar 26, 2002
JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE
K014303 · DWF
Jostra AG
Cardiovascular · 85d
Cleared Mar 25, 2002
ZOLL PAD
K011388 · MKJ
Zoll Medical Corp
Cardiovascular · 322d
Cleared Mar 21, 2002
DINAMAP PRO 1000 MONITOR, MODEL 1000
K012915 · MHX
Ge Medical Systems Information...
Cardiovascular · 203d
Cleared Mar 21, 2002
PVS 1500 SDS
K020733 · KRA
Precision Vascular Systems, Inc.
Cardiovascular · 15d
Cleared Mar 20, 2002
CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC...
K020316 · DQO
Cordis Corp.
Cardiovascular · 49d
Cleared Mar 20, 2002
PATIENTNET MONITORING SYSTEM
K020524 · MSX
General Electric Medical Systems...
Cardiovascular · 29d
Cleared Mar 20, 2002
PHILIPS MULTI-PARAMETER MODULE, MODEL M3001A
K020531 · MHX
Philips Medical Systems
Cardiovascular · 29d
Cleared Mar 19, 2002
ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01
K010253 · DYG
Transonic Systems, Inc.
Cardiovascular · 417d
Cleared Mar 19, 2002
HEARTTRENDS
K012825 · DQK
Lev-El, Ltd.
Cardiovascular · 208d
Cleared Mar 15, 2002
ENGUARD REMOTE PATIENT MONITOR
K020632 · QYX
Mennen Medical , Ltd.
Cardiovascular · 16d