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
10201–10224 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 19, 1997
MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT
K960766 · DYF
Meadox Medicals, Div. Boston...
Cardiovascular · 387d
Cleared Mar 19, 1997
VOLUME CONTROL SYRINGE MODEL VCD-SYR-10
K962141 · DXT
B.Braun Medical, Inc.
Cardiovascular · 289d
Cleared Mar 19, 1997
CHASE TWO STAGE VENOUS RETURN CATHETER
K964195 · DWF
Chase Medical, Inc.
Cardiovascular · 149d
Cleared Mar 19, 1997
CAHSE AORTIC ROOT CANNULA
K964198 · DWF
Chase Medical, Inc.
Cardiovascular · 149d
Cleared Mar 19, 1997
CHASE CORONARY SINUS PERFUSION CANNULA
K964199 · DWF
Chase Medical, Inc.
Cardiovascular · 149d
Cleared Mar 17, 1997
MEADOX EXXCEL EPTFE VASCULAR GRAFT
K962433 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 266d
Cleared Mar 17, 1997
DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR...
K964987 · DSP
Datascope Corp.
Cardiovascular · 94d
Cleared Mar 17, 1997
CARDIOBEEPER CB-12L
K965101 · DXH
Meridian Medical Technologies, Inc.
Cardiovascular · 87d
Cleared Mar 13, 1997
HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)
K963174 · DSH
Del Mar Avionics
Cardiovascular · 211d
Cleared Mar 12, 1997
MS-2000
K961144 · DXN
Touritu Engineering Co., Inc.
Cardiovascular · 356d
Cleared Mar 12, 1997
HEARTPORT NEEDLE TROCAR
K965051 · DRC
Heartport, Inc.
Cardiovascular · 84d
Cleared Mar 11, 1997
VESSEL DILATOR
K963388 · DRE
Maxxim Medical
Cardiovascular · 195d
Cleared Mar 11, 1997
EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND...
K963787 · DRX
Conmedcorp
Cardiovascular · 172d
Cleared Mar 11, 1997
VISTA BRITE TIP CATHETERS
K965211 · DQY
Cordis Corp.
Cardiovascular · 74d
Not Cleared Mar 10, 1997
BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION...
K964604 · DTB
Biotronik, Inc.
Cardiovascular · 112d
Cleared Mar 10, 1997
VASCUTEK TWILLWEAVE VASCULAR GRAFT
K964959 · DSY
Vascutek, Ltd.
Cardiovascular · 89d
Cleared Mar 10, 1997
GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR
K964973 · DTN
Gish Biomedical, Inc.
Cardiovascular · 88d
Cleared Mar 07, 1997
MODEL 700
K944180 · DSH
Memtec Corp.
Cardiovascular · 924d
Cleared Mar 06, 1997
CARDIOSERV P
K962547 · DRO
Marquette Electronics, Inc.
Cardiovascular · 251d
Cleared Mar 06, 1997
BIOCOR 200 HIGH PERFORMANCEOXYGENATOR
K964967 · DTZ
Minntech Corp.
Cardiovascular · 86d
Cleared Mar 06, 1997
QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES
K970391 · MKJ
Contour Medical Technology, Inc.
Cardiovascular · 31d
Cleared Mar 05, 1997
PS-41 6M PATIENT SIMULATOR
K963198 · DPS
Metron U.S., Inc.
Cardiovascular · 202d
Cleared Mar 04, 1997
OXIMETRIX 4 COMPUTER SYSTEM
K961661 · DXG
Abbott Laboratories
Cardiovascular · 308d
Cleared Mar 04, 1997
CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE
K965023 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 78d