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
10393–10416 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 10, 1996
FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS
K955628 · MKJ
Heartstream, Inc.
Cardiovascular · 274d
Cleared Sep 10, 1996
0.014 INCH EXTRA LONG FLOPPY AND 0.014 EXTRA LONG INTERMEDIATE GUIDE WIRES...
K962266 · DQX
Biocompatibles Cardiovascular, Inc.
Cardiovascular · 90d
Cleared Sep 10, 1996
HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH
K962342 · DXZ
Meadox Medicals, Div. Boston...
Cardiovascular · 84d
Cleared Sep 09, 1996
PERSONAL TELEMEDICINE SYSTEM
K952882 · DXN
American Telecare, Inc.
Cardiovascular · 444d
Cleared Sep 09, 1996
PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F
K960715 · MJN
Ideas For Medicine, Inc.
Cardiovascular · 201d
Cleared Sep 05, 1996
NEWMED ABP-LITE
K955887 · DXW
Newmed Corp.
Cardiovascular · 252d
Cleared Sep 05, 1996
BETTER-VENTER
K961594 · DWF
Circulatory Technology, Inc.
Cardiovascular · 134d
Cleared Sep 05, 1996
THUMPER CARDIOPULMONARY RESUSCITATOR
K962237 · DRM
Michigan Instruments, Inc.
Cardiovascular · 86d
Cleared Sep 04, 1996
BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT
K962177 · DSP
C.R. Bard, Inc.
Cardiovascular · 90d
Cleared Aug 29, 1996
CAMBRIDGE HEART HI-RES ECG ELECTRODE
K962115 · DRX
Cambridge Heart, Inc.
Cardiovascular · 90d
Cleared Aug 28, 1996
MEDILOG STRESSLINK
K951128 · DPS
Oxford Medical, Inc.
Cardiovascular · 534d
Cleared Aug 27, 1996
POSTERIOR ANNULOPLASTY BAND (MODEL 607)
K960356 · KRH
The Heart Valve Div. Medtronic...
Cardiovascular · 215d
Cleared Aug 27, 1996
CARBOMEDICS HANDLE
K962154 · DTJ
Carbomedics, Inc.
Cardiovascular · 84d
Cleared Aug 22, 1996
MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRICULAR/ATRIAL,...
K962036 · DTB
Medtronic Vascular
Cardiovascular · 90d
Cleared Aug 21, 1996
CARDIOCATH CATHETERIZATION LAB SYSTEM
K960321 · DPS
Prucka Engineering, Inc.
Cardiovascular · 212d
Cleared Aug 21, 1996
BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)
K962174 · DTB
Intermedics, Inc.
Cardiovascular · 77d
Cleared Aug 16, 1996
PATIENT MONITOR MODEL 405P
K955546 · DPS
Ivy Biomedical Systems, Inc.
Cardiovascular · 255d
Cleared Aug 15, 1996
DINAMAP SELECT MULTI-PARAMETER SYSTEM
K955113 · DPS
Johnson & Johnson Medical, Inc.
Cardiovascular · 281d
Cleared Aug 15, 1996
MODEL 2188 CORONARY SINUS LEAD.
K961936 · DTB
Medtronic Vascular
Cardiovascular · 87d
Cleared Aug 13, 1996
THE AMPLATZ THROMBECTOMY DEVICE
K954205 · MCW
Microvena Corp.
Cardiovascular · 341d
Cleared Aug 13, 1996
RMI HEMOCONCENTRACTOR TUBING SET
K961927 · DWF
Research Medical, Inc.
Cardiovascular · 88d
Cleared Aug 12, 1996
D. DEVICE II
K955742 · DXC
Yousef Daneshvar
Cardiovascular · 237d
Cleared Aug 12, 1996
INPUT TUOHY-BORST LOCKING DEVICE
K960445 · DYB
C.R. Bard, Inc.
Cardiovascular · 193d
Cleared Aug 12, 1996
DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40
K961869 · DTM
Sorin Biomedical, Inc.
Cardiovascular · 89d