FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,053 results
16921–16944 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 26, 1980
PROGRAMALITH #'S 221, 222, 221A & 222A
K801978 · DXY
Pacesetter Systems
Cardiovascular · 38d
Cleared Sep 26, 1980
IMPLANTABLE VENTRICULAR-INHIB. C.P. GEN
K802028 · DXY
Telectronics, Inc.
Cardiovascular · 36d
Cleared Sep 26, 1980
OXFORD INTENSIVE CARE PATIENT MON. SYS
K802033 · DSI
Oxford Medilog, Inc.
Cardiovascular · 35d
Cleared Sep 26, 1980
STIFF STYLETS
K802076 · DRB
Cardiac Pacemakers, Inc.
Cardiovascular · 29d
Cleared Sep 26, 1980
CARDIOTRAK
K802089 · DXH
Cardiac Pacemakers, Inc.
Cardiovascular · 24d
Cleared Sep 26, 1980
ECG RECALL & EDIT PRODUCT VERSION-A3601
K802103 · DSI
General Electric Co.
Cardiovascular · 23d
Cleared Sep 26, 1980
BENTLEY THEROMODILUTION CATHETER #BTD-7F
K802133 · KRB
Bentley Laboratories, Inc.
Cardiovascular · 22d
Cleared Sep 26, 1980
HS10 PORTABLE OPERATING ROOM MONITOR
K802184 · DRT
Medtel Pty. , Ltd.
Cardiovascular · 16d
Cleared Sep 26, 1980
BIOMETRIC SYSTOLIC TIME INTERVAL SYSTEM
K802198 · DXG
Biometric Analysis Group, Inc.
Cardiovascular · 16d
Cleared Sep 26, 1980
COMPUTER ECG TERMINAL
K802272 · DSI
Compumed, Inc.
Cardiovascular · 9d
Cleared Sep 18, 1980
IMPLANTABLE PROGRAM. CARDIAC PACEMAKER
K800793 · DXY
Telectronics, Inc.
Cardiovascular · 162d
Cleared Sep 16, 1980
SIEMENS-ELEMA PULSE GENERATOR 625
K801508 · DXY
Siemens Elema AB
Cardiovascular · 78d
Cleared Sep 16, 1980
CYNERGY MODEL 184
K801596 · DTE
Cynergy
Cardiovascular · 64d
Cleared Sep 16, 1980
DEKNATEL GOOSEN VASCULAR PUNCH BLADES
K802079 · DWS
Howmedica Corp.
Cardiovascular · 19d
Cleared Sep 16, 1980
SHILEY UTILITY RESERVOIR
K802119 · DTN
Shiley, Inc.
Cardiovascular · 12d
Cleared Sep 12, 1980
QUINTREX 0515 PROGRAMMABLE PULSE GEN.
K802223
Medcor, Inc.
Cardiovascular
Cleared Sep 12, 1980
QUINTREX 0516 PROG. PULSE GENERATOR SYS
K802224
Medcor, Inc.
Cardiovascular
Cleared Sep 09, 1980
MEDTRONIC MODEL 2409
K800226 · DXY
Medtronic Vascular
Cardiovascular · 217d
Cleared Sep 09, 1980
VASCULAR GRAFT PROSTH. OF EXP. MICRO.
K801621 · DSY
Impra, Inc.
Cardiovascular · 56d
Cleared Sep 09, 1980
EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE
K801806 · DXY
Arco Medical Products Co.
Cardiovascular · 41d
Cleared Sep 09, 1980
PALPATION ENHANCER
K801811 · LDE
Medical Horizons Co.
Cardiovascular · 63d
Cleared Sep 09, 1980
EVALUATOR #9500 DYNAMIC ELEC/SCANNER
K801831 · DSI
Del Mar Avionics
Cardiovascular · 39d
Cleared Sep 09, 1980
ELECTROCARDIOGRAPH ELECTRODE
K801846 · DRX
Phoenix Glove Co.
Cardiovascular · 36d
Cleared Sep 09, 1980
HANCOCK * OBTURATORS
K801885 · DTI
Hancock Laboratories, Inc.
Cardiovascular · 33d