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
9073–9096 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 25, 2000
WIZAIR COMPRESSION SYSTEM
K002287 · JOW
Medical Compression Systems (Dbn) , Ltd.
Cardiovascular · 29d
Cleared Aug 25, 2000
DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET
K002365 · DYB
Datascope Corp.
Cardiovascular · 22d
Cleared Aug 25, 2000
EHC500 DESKTOP PATIENT STATION, MODEL EHC500
K002388 · DXN
Cybercare, Inc.
Cardiovascular · 21d
Cleared Aug 24, 2000
HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE...
K002206 · DQX
Guidant Corp.
Cardiovascular · 34d
Cleared Aug 22, 2000
CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING
K002238 · DTN
Terumo Cardiovascular Systems Corp.
Cardiovascular · 29d
Cleared Aug 18, 2000
GE MARQUETTE ECG ANALYSIS PROGRAM
K002209 · MHX
General Electric Medical Systems...
Cardiovascular · 28d
Cleared Aug 18, 2000
CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002
K002230 · DRX
Cambridge Heart, Inc.
Cardiovascular · 25d
Cleared Aug 16, 2000
GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300
K001969 · DQY
Medtronic Vascular
Cardiovascular · 49d
Cleared Aug 16, 2000
SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX
K993698 · DRF
Mogul Enterprises
Cardiovascular · 288d
Cleared Aug 15, 2000
V QUICK PATCH
K993934 · DRX
Vq Corp.
Cardiovascular · 271d
Cleared Aug 11, 2000
BMT ANSCORE HEALTH MANAGEMENT SYSTEM
K993875 · DPS
Boston Medical Technologies, Inc.
Cardiovascular · 270d
Cleared Aug 10, 2000
CARDIOSET (HARDWARE), MODEL HO4
K001091 · DXH
Next Millennium Software Solutions, Inc.
Cardiovascular · 128d
Cleared Aug 10, 2000
STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT,...
K001565 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 83d
Cleared Aug 09, 2000
QUINTON Q-STRESS, MODEL 000483
K001492 · DPS
Quinton, Inc.
Cardiovascular · 89d
Cleared Aug 09, 2000
S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0
K002116 · DTQ
Medical Device Consultants, Inc.
Cardiovascular · 27d
Cleared Aug 09, 2000
STOCKERT COMPACT SYSTEM VERSION 2.0
K002118 · DTQ
Stoeckert Instrumente
Cardiovascular · 27d
Cleared Aug 09, 2000
TRUE
K993913 · LIT
Infinity Extrusion & Engineering, Inc.
Cardiovascular · 266d
Cleared Aug 04, 2000
R.TEST EVOLUTION
K993788 · MLO
Novacor Div.
Cardiovascular · 269d
Cleared Aug 03, 2000
MIRAGE HYDROPHILIC GUIDEWIRE, MODEL 103-0608
K002212 · DQX
Micro Therapeutics, Inc.
Cardiovascular · 13d
Cleared Aug 03, 2000
EXCELSIOR 1018 MICROCATHETER
K994155 · KRA
Boston Scientific, Target
Cardiovascular · 238d
Cleared Aug 02, 2000
CHASE CARDIOVASCULAR PATCH
K001662 · DXZ
Chase Medical, Inc.
Cardiovascular · 63d
Cleared Aug 02, 2000
GALEO HYDRO AND GALEO HYDRO J-TIP
K001736 · DQX
Biotronik, Inc.
Cardiovascular · 56d
Cleared Aug 02, 2000
HP M2376A DEVICE LINK SYSTEM, MODEL M2376A
K002009 · MWI
Agilent Technologies, Inc.
Cardiovascular · 30d
Cleared Aug 01, 2000
COAXIAL DILATOR SET
K000737 · DRE
Xentek Medical, Inc.
Cardiovascular · 147d