FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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 · Free access · No registration required

Filters: Cardiovascular ×
18,151 results
15961–15984 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 15, 1983
COMMAND ULTRA I
K831161 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 65d
Cleared Jun 15, 1983
METAL-BACKED ACETABULAR CUP
K831479 · DXQ
Dow Corning Corp. Healthcare...
Cardiovascular · 37d
Cleared Jun 08, 1983
VITAL SIGNS MONITOR 2
K830587 · DRT
Physio-Control Corp.
Cardiovascular · 105d
Cleared Jun 08, 1983
LS-1 PORTABLE BLOOD PRESSURE COMPUTER
K830713 · DXN
Vita-Stat Medical Services, Inc.
Cardiovascular · 92d
Cleared Jun 08, 1983
BIO-PROBE SYSTEM-BLOOD FLOW PROBE
K830858 · DPT
Bio Medicus, Inc.
Cardiovascular · 83d
Cleared Jun 08, 1983
ULTIPORE PREBYPASS PLUS FILTER
K831286 · KRJ
Pall Biomedical Products Co.
Cardiovascular · 49d
Cleared Jun 08, 1983
LOW PROFILE STEERABLE BALLOON DILATA
K831403 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 37d
Cleared Jun 08, 1983
VENTRICULAR PACING LEADS MODELS 865/867
K831435 · DTB
Pacesetter Systems
Cardiovascular · 35d
Cleared Jun 08, 1983
UNIPOLAR ATRIAL J PACING LEAD MODEL 869
K831436 · DTB
Pacesetter Systems
Cardiovascular · 35d
Cleared Jun 08, 1983
ANGIOGRAPHY KIT W/ADDIT. COMPONENTS
K831509 · DQO
Mallinckrodt Critical Care
Cardiovascular · 28d
Cleared Jun 03, 1983
VENTURE II MONITORING SYSTEM
K830321 · DSF
Rae Medical Corp.
Cardiovascular · 123d
Cleared Jun 03, 1983
INFANT ELECTRODE BELT
K830362 · DRX
Sentry Medical Products, Inc.
Cardiovascular · 120d
Cleared Jun 03, 1983
SCI MED TEMPERATURE MONITORING ADAPTOR
K831260 · DTL
Scimed Life Systems, Inc.
Cardiovascular · 46d
Cleared Jun 03, 1983
SCI MED TUBING CONNECTORS
K831261 · DTL
Scimed Life Systems, Inc.
Cardiovascular · 46d
Cleared Jun 02, 1983
ANGIOSCOPE
K830084 · LYK
Trimedyne, Inc.
Cardiovascular · 142d
Cleared Jun 02, 1983
REAL-TIME SPECTRUM ANALYZER
K830628 · DXG
Diagnostic Electronics Corp.
Cardiovascular · 93d
Cleared May 27, 1983
SIEMENS-ELMA PULSE GENERATOR #718
K830344 · DXY
Burditt & Calkins-Siemens-Elema
Cardiovascular · 114d
Cleared May 27, 1983
CARDIAC OUTPUT MEASURE SYSTEM
K831185 · DYG
Cook, Inc.
Cardiovascular · 45d
Cleared May 27, 1983
GAS-STAT MONITORING SYSTEM
K831225 · DRY
Cardiovascular Devices, Inc.
Cardiovascular · 42d
Cleared May 27, 1983
FLUID ADMIN. SET AFS-1C
K831348 · DRS
Linton Biomed Corp.
Cardiovascular · 32d
Cleared May 25, 1983
MODEL 515 NEO-TRAK NEONATAL MONITOR
K823904 · DRT
Ge Medical Systems Information...
Cardiovascular · 148d
Cleared May 25, 1983
RECORDER DMI
K830489 · DSH
Diagnostic Medical Instruments
Cardiovascular · 99d
Cleared May 25, 1983
CONVERTER UNIT FOR ECG TRACE DISPLAY
K830566 · DPS
Honeywell, Inc.
Cardiovascular · 91d
Cleared May 25, 1983
LINEAR PUMP #4370975
K830577 · JOW
Wright Linear Pump, Inc.
Cardiovascular · 91d