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
17665–17688 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 20, 1978
SEQUENTIAL CUFF INFLATION DEVICE
K781358 · JOW
Medasonics, Inc.
Cardiovascular · 43d
Cleared Sep 20, 1978
INSTA-PULSE HEART RATE MONITOR
K781387 · DRT
Bio Sig Instruments, Inc.
Cardiovascular · 41d
Cleared Sep 15, 1978
AC ADAPTER:MODELS 9525,9526,9527
K781535 · DXG
Edwards Laboratories
Cardiovascular · 9d
Cleared Sep 14, 1978
OXYGENATOR, BUBBLE TYPE
K780078 · DTZ
Bentley Laboratories, Inc.
Cardiovascular · 240d
Cleared Sep 07, 1978
DINAMAP MODEL 846
K781053 · DSK
Applied Medical Research
Cardiovascular · 77d
Cleared Sep 07, 1978
DINAMAP MODEL 848
K781064 · DSK
Applied Medical Research
Cardiovascular · 73d
Cleared Sep 07, 1978
GENERATOR, CARDIAC PULSE, 250B
K781090 · DXY
Telectronics, Inc.
Cardiovascular · 66d
Cleared Sep 07, 1978
PULSE GENERATOR MODEL 208
K781178 · DXY
Elema-Schonander, Inc.
Cardiovascular · 59d
Cleared Sep 07, 1978
MASK, PXYGEN
K781413 · DPT
Vitalab Products Corp.
Cardiovascular · 23d
Cleared Sep 07, 1978
CARDIAL PULSE GENERATORS
K781426 · DXY
Telectronics, Inc.
Cardiovascular · 16d
Cleared Sep 01, 1978
BJORK-SHILEY CARDIAC HEART VALVE
K780772
Shiley, Inc.
Cardiovascular · 120d
Cleared Aug 31, 1978
PACEMAKER, ELECTRODE, PERMANENT & TEMP.
K780246 · DTB
Daig Corp.
Cardiovascular · 199d
Cleared Aug 31, 1978
MODEL 20 DIGITAL PULSE RATE MONITOR
K780937 · DRT
Sentronix, Inc.
Cardiovascular · 84d
Cleared Aug 31, 1978
MODEL 1812 CONTROL CONSOLE, ACCESSORIEX
K780952 · DWA
Medtronic Vascular
Cardiovascular · 83d
Cleared Aug 31, 1978
MODEL 1861 BLOOD PUMP
K780953 · KFM
Medtronic Vascular
Cardiovascular · 83d
Cleared Aug 31, 1978
LEAD CONVERSION KIT, MODEL 341
K781111
Edwards Pacemaker Systems
Cardiovascular · 59d
Cleared Aug 31, 1978
ELECTROCARDIOGRAPHIC ECG RECORDER
K781152 · DSM
Cardio-Dynamics Laboratories, Inc.
Cardiovascular · 52d
Cleared Aug 31, 1978
GENERATOR, PULSE, PACEMAKER
K781168 · DXY
Vitatron Medical BV
Cardiovascular · 49d
Cleared Aug 31, 1978
ECON-O2
K781219
Mountain Medical Equipment, Inc.
Cardiovascular · 45d
Cleared Aug 31, 1978
PACER-TRACER PULSE WIDTH
K781349 · DTC
Instromedix, Inc.
Cardiovascular · 24d
Cleared Aug 23, 1978
ANALYZER, PACER SYSTEM, PSA-5
K781144 · DTC
Edwards Pacemaker Systems
Cardiovascular · 44d
Cleared Aug 23, 1978
DILUTION KIT, THERMAL, COLD PAC
K781221 · DRC
Instrumentation Laboratory CO
Cardiovascular · 37d
Cleared Aug 17, 1978
CATHETER, THERMAL DILUTION FIBEROPTIC
K781134 · DQE
Oximetrix, Inc.
Cardiovascular · 42d
Cleared Aug 17, 1978
DISPOSABLE SYRINGE FILL TUBE
K781334 · DXT
Mallinckrodt Group, Inc.
Cardiovascular · 15d