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
10369–10392 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 07, 1996
CAPIOX SX25 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR
K962667 · DTZ
Terumo Medical Corp.
Cardiovascular · 90d
Cleared Oct 04, 1996
RNS STERILE, DISPOSABLE CT BIOPSY TRAY
K955685 · DXT
Contour Fabricators of Florida, Inc.
Cardiovascular · 295d
Cleared Oct 03, 1996
IMPRA CARBOFLO EPTFE VASCULAR GRAFT
K962639 · DSY
Impra, Inc.
Cardiovascular · 90d
Cleared Oct 02, 1996
DANESHVAR WOUND SUPPORT UNIT
K955827 · DXC
Y. Daneshvar
Cardiovascular · 281d
Cleared Oct 02, 1996
EAGLE 3000/3100 PATIENT MONITOR
K960272 · MLD
Marquette Electronics, Inc.
Cardiovascular · 258d
Cleared Oct 02, 1996
EAGLE PATIENT MONITOR
K960418 · DSI
Marquette Electronics, Inc.
Cardiovascular · 247d
Cleared Oct 02, 1996
CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL...
K961000 · DTZ
Terumo Medical Corp.
Cardiovascular · 204d
Cleared Oct 01, 1996
B. BRAUN GUIDEWIRES
K961107 · DQX
B.Braun Medical, Inc.
Cardiovascular · 195d
Cleared Sep 30, 1996
HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG...
K962858 · DXC
Heartport, Inc.
Cardiovascular · 70d
Cleared Sep 27, 1996
MAGLIFE
K950264 · MHX
Odam
Cardiovascular · 613d
Not Cleared Sep 27, 1996
UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER...
K953044 · DTB
Biotronik, Inc.
Cardiovascular · 455d
Cleared Sep 26, 1996
EUREDUC PNEUMATIC DRAINAGE SYSTEM MODEL TP03
K960902 · JOW
Eureduc
Cardiovascular · 205d
Cleared Sep 19, 1996
CONTRAST INJECTION LINES
K960674 · DXT
B.Braun Medical, Inc.
Cardiovascular · 212d
Cleared Sep 19, 1996
VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE
K961716 · DXE
Ideas For Medicine, Inc.
Cardiovascular · 140d
Cleared Sep 18, 1996
CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER
K953663 · DRF
Cordis Webster, Inc.
Cardiovascular · 408d
Cleared Sep 17, 1996
BRAUN PERCUTANEOUS INTRODUCER SET
K961745 · DYB
B.Braun Medical, Inc.
Cardiovascular · 134d
Cleared Sep 17, 1996
RHYDER DIAGNOSTIC CATHETER
K962307 · DRF
Fidus Medical Technology Corp.
Cardiovascular · 92d
Cleared Sep 17, 1996
RV PACING LEAD
K962467 · LDF
Abbott Laboratories
Cardiovascular · 84d
Cleared Sep 12, 1996
FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL...
K960965 · DXT
Coeur Laboratories, Inc.
Cardiovascular · 185d
Cleared Sep 12, 1996
PERCUTANEOUS INTRODUCER SET
K961466 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 148d
Cleared Sep 12, 1996
BIPORE BALLOON DILATATION CATHETER
K961980 · LIT
Bipore, Inc.
Cardiovascular · 115d
Cleared Sep 12, 1996
INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING...
K962495 · MAV
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 78d
Cleared Sep 11, 1996
HEARTPORT ENDOAORTIC CLAMP
K962510 · DXC
Heartport, Inc.
Cardiovascular · 76d
Cleared Sep 10, 1996
CARD GUARD MODEL CG-6500
K954350 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 358d