FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,053 results
14545–14568 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 11, 1986
THE HOLTER REPORTER (TM)
K860249 · DPS
Applied Cardiac Systems
Cardiovascular · 46d
Cleared Mar 10, 1986
SONOLINE SX ULTRASOUND SCANNER
K852739 · DXK
Siemens Medical Solutions USA, Inc.
Cardiovascular · 256d
Cleared Mar 07, 1986
PHOENIX MODELS 250/251 PULSE GENERATORS
K855081 · DXY
Pacesetter Systems
Cardiovascular · 78d
Cleared Mar 03, 1986
ADJUSTABLE OXYGENATOR HOLDER MODEL NO. BCM-HL
K860672 · KRI
American Bentley
Cardiovascular · 7d
Cleared Feb 28, 1986
MOLDTEC STIMULATOR
K853757 · DRT
Moldtec, Inc.
Cardiovascular · 172d
Cleared Feb 28, 1986
DOBE (MODIFIED)
K853993 · DRX
Phoenix Medical Technology, Inc.
Cardiovascular · 154d
Cleared Feb 28, 1986
TRANSTELEPHONIC ECG RECORDER/TRANSMITTER & RECEIVE
K854013 · DXH
Medrand, Inc.
Cardiovascular · 151d
Cleared Feb 28, 1986
WEP 7604 TELEMETRY MONITOR
K854369 · DXH
Nihon Kohden America, Inc.
Cardiovascular · 122d
Cleared Feb 28, 1986
VM 781 SLAVE SCOPE
K854372 · DXJ
Nihon Kohden America, Inc.
Cardiovascular · 122d
Cleared Feb 28, 1986
ALTERNATE STERILE PKG IMPLANTABLE PULSE GENERATORS
K854482 · DXY
Medtronic Vascular
Cardiovascular · 113d
Cleared Feb 26, 1986
GRECO-HARVEY SURFACTANT BONDED CATHETER FOR CARDIO
K851241 · DQY
Cook, Inc.
Cardiovascular · 365d
Cleared Feb 26, 1986
SENTRY II NONINDWELLING BLOOD PRESSURE MONITOR
K852421 · DXN
Nbs Medical, Inc.
Cardiovascular · 264d
Cleared Feb 26, 1986
CARDISUNY 501 A
K852829 · DPS
Atrix
Cardiovascular · 238d
Cleared Feb 26, 1986
OSCOR MEDICAL UNIPOLAR PERMANENT PACING LEAD-CONNE
K854128 · DTB
Oscor Medical Corp.
Cardiovascular · 140d
Cleared Feb 26, 1986
HEATER PROBE-ACCESS FOR MEDPACIFIC LD5000 LASER -
K854500 · DPW
Medpacific Corp.
Cardiovascular · 106d
Cleared Feb 26, 1986
MODIFIED CORDIS PTCA GUIDING CATHETERS
K854576 · DQO
Cordis Corp.
Cardiovascular · 105d
Cleared Feb 26, 1986
AMI E-Z-PACE ELECTODE
K854924 · DRO
A.M.I. Corp.
Cardiovascular · 78d
Cleared Feb 26, 1986
MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR
K855049 · DTP
Scimed Life Systems, Inc.
Cardiovascular · 71d
Cleared Feb 26, 1986
SWANK ARTERIAL LINE BLOOD FILTER HF6000
K855066 · DTM
Cobe Laboratories, Inc.
Cardiovascular · 70d
Cleared Feb 26, 1986
SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100
K855067 · JOD
Cobe Laboratories, Inc.
Cardiovascular · 70d
Cleared Feb 26, 1986
CORDIS CATHETER SHEATH INTRODUCERS,STERI-SLEEVES
K855126 · DYB
Cordis Corp.
Cardiovascular · 65d
Cleared Feb 26, 1986
FLEXON TEMPORARY CARDIAC CONDUCTIVE MULTIFILAMENT
K855139 · LDF
Davis & Geck, Inc.
Cardiovascular · 65d
Cleared Feb 26, 1986
MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR
K855145 · DRS
Gould, Inc.
Cardiovascular · 64d
Cleared Feb 26, 1986
MEDILOG 2500 SYSTEM
K860078 · DSI
Oxford Medilog, Inc.
Cardiovascular · 49d