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
9841–9864 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 13, 1998
HI-TORQUE FLOPPY GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE...
K974773 · DQX
Guidant Corp.
Cardiovascular · 81d
Cleared Mar 12, 1998
CARDIOSMART ST
K973403 · LOS
Marquette Medical Systems, Inc.
Cardiovascular · 184d
Cleared Mar 12, 1998
TS2000 MEDICAL DEVICE MONITOR
K973640 · MSX
Trincore Systems, Inc.
Cardiovascular · 169d
Cleared Mar 11, 1998
ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B
K972603 · DPS
Dr. Lee Co., Ltd.
Cardiovascular · 243d
Cleared Mar 11, 1998
TEMPORARY OCCLUSION BALLOON SYSTEM
K972777 · MJN
Percu Surge, Inc.
Cardiovascular · 229d
Cleared Mar 11, 1998
REUSABLE FINGER SENSOR 3444
K974697 · DQH
Bci Intl., Inc.
Cardiovascular · 85d
Cleared Mar 06, 1998
AMPLATZ GOOSE NECK SNARE KIT/ CATHETER
K972511 · DXE
Microvena Corp.
Cardiovascular · 246d
Cleared Mar 04, 1998
OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM
K971840 · MHX
Invivo Research, Inc.
Cardiovascular · 289d
Not Cleared Mar 04, 1998
TIR/TIJ AND POLYROX
K972500 · DTB
Biotronik, Inc.
Cardiovascular · 244d
Cleared Mar 04, 1998
BIOSENSOR HOLTER MONITOR SYSTEM
K974192 · DQK
Biosensor Corp.
Cardiovascular · 117d
Cleared Mar 04, 1998
BIOSENSOR HOLTER MONITOR SYSTEM
K974546 · DQK
Biosensor Corp.
Cardiovascular · 90d
Cleared Mar 02, 1998
PORTABLE INTENSIVE CARE UNIT
K974034 · DRO
Medical Research Laboratories, Inc.
Cardiovascular · 130d
Cleared Feb 27, 1998
MICROFUSE MEMBRANE INFUSION CATHETER
K971619 · KRA
E-Med Corp.
Cardiovascular · 302d
Cleared Feb 27, 1998
S3 MAST PUMP
K972321 · DWB
Stoeckert Instrumente
Cardiovascular · 249d
Cleared Feb 27, 1998
FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE
K974067 · QEY
Merit Medical Systems, Inc.
Cardiovascular · 123d
Cleared Feb 26, 1998
SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT...
K974492 · MLD
Siemens Medical Solutions USA, Inc.
Cardiovascular · 90d
Cleared Feb 25, 1998
BPX80 BIO-PUMP (BPX80)
K973011 · KFM
Medtronic Bio-Medicus, Inc.
Cardiovascular · 196d
Cleared Feb 23, 1998
LOCATOR MODEL 4036
K972814 · DTB
Pacesetter, Inc.
Cardiovascular · 209d
Cleared Feb 23, 1998
SURGICAL VASCULAR CLAMP
K973080 · DXC
Walter Lorenz Surgical, Inc.
Cardiovascular · 189d
Cleared Feb 23, 1998
SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS
K974559 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 80d
Cleared Feb 20, 1998
CARDIO-CARD MANAGEMENT SYSTEM II
K972795 · DXN
Nasiff Assoc., Inc.
Cardiovascular · 207d
Cleared Feb 19, 1998
MOBIMED SYSTEM, (PEGASUS AND POLARIS)
K973318 · MSX
Ortivus Us, Inc.
Cardiovascular · 168d
Cleared Feb 19, 1998
LATIS GRAFT CLEANING CATHETER
K973465 · DXE
Applied Medical Resources
Cardiovascular · 160d
Cleared Feb 19, 1998
BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS
K973962 · DSP
C.R. Bard, Inc.
Cardiovascular · 126d