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
16129–16152 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 30, 1982
HOLTER KIT MODEL #5000 SERIES
K823414 · DSH
Andover Medical, Inc.
Cardiovascular · 45d
Cleared Dec 30, 1982
MON-A-THERM MYOCARDIAL TEMP. SENSOR
K823435 · KRB
Burditt & Calkins-Siemens-Elema
Cardiovascular · 44d
Cleared Dec 30, 1982
OXYGENATORS #BOS-10, 105, 5S
K823456 · DTZ
Bentley Laboratories, Inc.
Cardiovascular · 42d
Cleared Dec 30, 1982
ELECTROCARDIOGRAPH #334
K823488 · DPS
Birtcher Corp.
Cardiovascular · 37d
Cleared Dec 30, 1982
JACKET & SET
K823533 · DTR
Shiley, Inc.
Cardiovascular · 31d
Cleared Dec 30, 1982
FUKUDA DENSHI 6-CHANNEL AUTO. ELECTRO-
K823584 · DPS
Brentwood Instruments, Inc.
Cardiovascular · 24d
Cleared Dec 29, 1982
FEP-RINGED GORE-TEX@ VASCULAR GRAFT
K821826 · DYF
W.L. Gore & Associates, Inc.
Cardiovascular · 190d
Cleared Dec 22, 1982
EXTRACORPOREAL BLOOD GAS SYSTEM
K822000 · DTY
Cardiovascular Devices, Inc.
Cardiovascular · 168d
Cleared Dec 22, 1982
MODEL RM 6000, 6100,6200 POLYGRAPH
K823281 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 49d
Cleared Dec 22, 1982
DURAPULSE
K823371 · DXY
Cpm International, Inc.
Cardiovascular · 40d
Cleared Dec 22, 1982
THERMAL DILUTION CATHETER
K823484 · DYG
Instrumentation Laboratory CO
Cardiovascular · 29d
Cleared Dec 22, 1982
TELEMETRY DECODER #540-02
K823678 · DXY
Intermedics, Inc.
Cardiovascular · 16d
Cleared Dec 21, 1982
DATASCOPE MODEL 83 IABP SYSTEM
K821951 · DSP
Datascope Corp.
Cardiovascular · 174d
Cleared Dec 15, 1982
CORATOMIC #VX5-105 & VX5-205 PULSE GEN.
K822791 · DXY
Coratomic, Inc.
Cardiovascular · 91d
Cleared Dec 15, 1982
HTS *1
K822843 · DSK
Global Office Automation System, Inc.
Cardiovascular · 83d
Cleared Dec 15, 1982
ELECTROCARDIOGRAPH INTERPRETER
K822968 · DSI
Suzuken Co., Ltd.
Cardiovascular · 69d
Cleared Dec 15, 1982
MINGOGRAF 4, MINGO CARD 4 & MINOCARD 3
K822978 · DSF
Siemens Corp.
Cardiovascular · 68d
Cleared Dec 15, 1982
SEA MED MODEL 880
K823048 · DTE
Seamed Corp.
Cardiovascular · 61d
Cleared Dec 15, 1982
INTRA CATH-DSA INTRAVENOUS CATH PLACE.
K823065 · DQO
Parke-Davis Co.
Cardiovascular · 58d
Cleared Dec 15, 1982
CARDIAC ELEVATOR
K823094 · DWS
Cardio Surgical Research, Inc.
Cardiovascular · 56d
Cleared Dec 15, 1982
SMEC BALLOON SYSTEM
K823177 · DSP
Smec, Inc.
Cardiovascular · 50d
Cleared Dec 15, 1982
OXYGENATOR 10
K823343 · DTZ
Gambro, Inc.
Cardiovascular · 37d
Cleared Dec 15, 1982
FULL-DISCLOSURE AMBULATORY ECG SYSTEM
K823529 · DPS
Clinical Data, Inc.
Cardiovascular · 22d
Cleared Dec 03, 1982
READY-BOX BODY-TEMP MEDIA WARMER MALLIN-
K823356 · DXT
Forma Scientific, Inc.
Cardiovascular · 24d