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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,151 results
10609–10632 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 25, 1996
BRAUN HEMOSTASIS INTRODUCERS
K955820 · DYB
B.Braun Medical, Inc.
Cardiovascular · 90d
Cleared Mar 22, 1996
SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE
K955869 · MAV
Scimed Life Systems, Inc.
Cardiovascular · 87d
Cleared Mar 21, 1996
LASERFLO BLOOD PERFUSION SINGLE USE PROBES MODELS SUP-440, SUPR-434 SUP-433
K951832 · DPT
Vasamedics, LLC
Cardiovascular · 336d
Cleared Mar 18, 1996
ZYMED HOLTER SCANNER MODEL 2010
K955015 · DQK
Zymed Medical Instrumentation
Cardiovascular · 138d
Cleared Mar 15, 1996
LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR
K953835 · DTZ
Dideco S.R.L.
Cardiovascular · 212d
Cleared Mar 15, 1996
FLEXON TEMPORARY CARDIAC PACER LEAD
K955722 · LDF
Davis & Geck, Inc.
Cardiovascular · 88d
Cleared Mar 13, 1996
CLINICAL VITAL SIGNS MONITOR, MODEL #52STP-E1
K951193 · DXN
Tycos Instruments, Inc.
Cardiovascular · 363d
Cleared Mar 12, 1996
TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SET
K955785 · DYB
C.R. Bard, Inc.
Cardiovascular · 82d
Cleared Mar 11, 1996
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
K953750 · DRF
Boston Scientific Corp
Cardiovascular · 214d
Cleared Mar 11, 1996
LMI OCCLUSION CATHETER
K955125 · DXE
Lucas Medical, Inc.
Cardiovascular · 123d
Cleared Mar 11, 1996
DIASTAT VASCULAR ACCESS GRAFT
K955532 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 97d
Cleared Mar 11, 1996
ESSENCE GUIDEWIRE
K955637 · DQX
Cordis Neurovascular, Inc.
Cardiovascular · 91d
Cleared Mar 11, 1996
MEGA PTA BALLOON CATHETER
K955886 · LIT
Cordis Corp.
Cardiovascular · 74d
Cleared Mar 08, 1996
VITAL PAK
K955417 · DXG
Vital Signs, Inc.
Cardiovascular · 102d
Cleared Mar 07, 1996
BIOCOR 200 HARDSHELL VENOUS RESERVIOR
K953821 · DTN
Minntech Corp.
Cardiovascular · 205d
Cleared Mar 07, 1996
VASCUTEK GRAFT SIZER SET
K955588 · DSY
Carbomedics, Inc.
Cardiovascular · 91d
Cleared Mar 06, 1996
MYOCARDIAL PROTECTION SYSTEM
K953838 · DTR
Quest Medical, Inc.
Cardiovascular · 203d
Cleared Mar 04, 1996
PIKOS LP 01, PIKOS LP E01
K945627 · DXY
Biotronik, Inc.
Cardiovascular · 474d
Cleared Mar 04, 1996
REDOX
K953850 · JOW
Kinetic Concepts, Inc.
Cardiovascular · 201d
Cleared Mar 04, 1996
HEMO-VALVE
K955554 · DTL
North American Instrument Corp.
Cardiovascular · 90d
Cleared Mar 01, 1996
CARDIOPHONICS INCORPORATED DPS 2000 PHONOCARDIOGRAPH
K950537 · DQC
Cardiophonics, Inc.
Cardiovascular · 388d
Cleared Feb 29, 1996
CAMBRIDGE HEART CH 2000 STRESS TEST SYSTEM
K950018 · DPS
Cambridge Heart, Inc.
Cardiovascular · 422d
Cleared Feb 29, 1996
ACCUSTRESS EXERCISE TESTING SYSTEM
K953127 · DQK
Hewlett-Packard Co.
Cardiovascular · 239d
Cleared Feb 28, 1996
ART-ASSIST MODEL AA-1000
K942530 · JOW
Aci Medical, Inc.
Cardiovascular · 642d