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
9625–9648 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 20, 1998
URESIL VASCU-FLO INFUSION CATHETER
K980278 · DQY
Uresil Corp.
Cardiovascular · 298d
Cleared Nov 20, 1998
MODIFICATION TO PORTABLE INTENSIVE CARE UNIT
K983307 · MKJ
Medical Research Laboratories, Inc.
Cardiovascular · 60d
Cleared Nov 19, 1998
IMPRA HIGH POROSITY GRAFT
K983064 · DSY
Impra, Inc.
Cardiovascular · 78d
Cleared Nov 18, 1998
AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT...
K982657 · MCW
Microvena Corp.
Cardiovascular · 111d
Cleared Nov 17, 1998
FUZZY TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL #'S HD-1000S & HD-2000F
K983855 · DXN
Jawon Medical Co., Ltd.
Cardiovascular · 15d
Cleared Nov 16, 1998
CENTURION CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM
K980045 · DSI
Invivo Research, Inc.
Cardiovascular · 314d
Cleared Nov 16, 1998
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM ENHANCEMENT, ADDITIONAL...
K983980 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 7d
Cleared Nov 13, 1998
MEDI-TRACE 4103 NEONATAL ELECTRODE
K981964 · DRX
Graphic Controls Corp.
Cardiovascular · 162d
Cleared Nov 13, 1998
HEARTLINK, MODEL II
K982803 · QYX
Cardiac Telecom Corp.
Cardiovascular · 95d
Cleared Nov 13, 1998
CARDIOBEEPER CB250
K983582 · DXH
Merdian Medical Technologies , Ltd.
Cardiovascular · 31d
Cleared Nov 12, 1998
SCIMED INFORMER PRESSURE WIRE SYSTEM
K974241 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 365d
Cleared Nov 12, 1998
CV PERI-GUARD AND VASCU-GUARD
K983602 · DXZ
Bio-Vascular, Inc.
Cardiovascular · 30d
Cleared Nov 12, 1998
STRATEGY CORONARY WIRE GUIDE
K983771 · DQX
Cook, Inc.
Cardiovascular · 17d
Cleared Nov 10, 1998
CMS-2000
K982843 · MWJ
Industrial Technology Research Institute
Cardiovascular · 90d
Cleared Nov 10, 1998
HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282
K982876 · DQX
Guidant Corp.
Cardiovascular · 88d
Cleared Nov 10, 1998
DIGITAL ECG HOLTER RECORDER, MODEL DR512
K982975 · MWJ
Datrix
Cardiovascular · 76d
Cleared Nov 10, 1998
ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE
K983033 · DQX
Guidant Corp.
Cardiovascular · 71d
Cleared Nov 06, 1998
SIEMENS SC 8000 BEDSIDE MONITOR
K983632 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 22d
Cleared Nov 05, 1998
MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE
K983287 · MKJ
Graphic Controls Corp.
Cardiovascular · 48d
Cleared Nov 04, 1998
BLOOD PRESSURE MEASUREMENT SYSTEM(DSPM-70)
K971616 · DQO
Data Sciences Intl., Inc.
Cardiovascular · 551d
Cleared Nov 03, 1998
DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1
K981378 · DRT
Datex-Engstrom, Inc.
Cardiovascular · 201d
Cleared Oct 29, 1998
ELECTRODE SWITCHBOX, MODEL 11-081002
K982835 · DRF
Cardima, Inc.
Cardiovascular · 78d
Cleared Oct 28, 1998
MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT
K974581 · DRT
Invivo Research, Inc.
Cardiovascular · 324d
Cleared Oct 28, 1998
SHELHIGH NO-REACT VASCUPATCH
K982810 · DXZ
Shelhigh, Inc.
Cardiovascular · 78d