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
14377–14400 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 17, 1986
DISPOSABLE FLUSH DEVICE
K860681 · DRS
Hewlett-Packard Co.
Cardiovascular · 112d
Cleared Jun 17, 1986
MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN
K862037 · DXY
Medtronic Vascular
Cardiovascular · 20d
Cleared Jun 17, 1986
MODIFY LABEL/SPECTRAX S & SX IMPLANT PULSE GENER
K862038 · DXY
Medtronic Vascular
Cardiovascular · 20d
Cleared Jun 17, 1986
MODIFIED LABEL FOR/SPECTRAX SXT IMPLANT. PULSE GEN
K862071 · DXY
Medtronic Vascular
Cardiovascular · 18d
Cleared Jun 16, 1986
ERG 550 ERGOMETER BICYCLE
K854491 · DRT
Robert Bosch Corp.
Cardiovascular · 216d
Cleared Jun 16, 1986
ERG 551 ERGOMETER, BICYCLE
K854492 · DRT
Robert Bosch Corp.
Cardiovascular · 216d
Cleared Jun 16, 1986
ERG 555 COUCH ERGOMETER
K854493 · DRT
Robert Bosch Corp.
Cardiovascular · 216d
Cleared Jun 16, 1986
PHYSIO-DYNE ECG/HR 3
K854847 · DRT
Physio-Dyne Industrument Corp.
Cardiovascular · 194d
Cleared Jun 16, 1986
ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE
K861847 · LOX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 34d
Cleared Jun 13, 1986
MODEL 486-02 ENDOCARDIAL PACING LEAD
K860547 · DTB
Intermedics, Inc.
Cardiovascular · 120d
Cleared Jun 13, 1986
MODEL 492-02 ENDOCARDIAL PACING LEAD
K860548 · DTB
Intermedics, Inc.
Cardiovascular · 120d
Cleared Jun 09, 1986
LIFESTAT 100
K853561 · DXN
Physio-Control Corp.
Cardiovascular · 287d
Cleared Jun 09, 1986
COLIN ELECTRONICS CO., LTD. STBP 680
K854481 · DXN
Colin Medical Instruments Corp.
Cardiovascular · 214d
Cleared Jun 09, 1986
SCHNEIDER-SHILEY WIRE TORQUER
K861606 · DQX
Shiley, Inc.
Cardiovascular · 41d
Cleared Jun 09, 1986
SCHNEIDER-SHILEY INFLATION SYRINGES
K861607 · MAV
Shiley, Inc.
Cardiovascular · 41d
Cleared Jun 09, 1986
MODEL 43200A CARDIAC MONITOR
K861992 · DPS
Hewlett-Packard Co.
Cardiovascular · 17d
Cleared Jun 06, 1986
SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN
K860584 · KRG
Cardiac Pacemakers, Inc.
Cardiovascular · 108d
Cleared Jun 06, 1986
ENDOCARDIAL CARBON-TIP LEAD
K861481 · DTB
Pacesetter Systems
Cardiovascular · 45d
Cleared Jun 06, 1986
MICRO ANASTOMOSIS CLAMP
K861924 · DXC
Pilling Co.
Cardiovascular · 18d
Cleared Jun 05, 1986
2500 PRINTER
K860164
Datascope Corp.
Cardiovascular · 139d
Cleared Jun 05, 1986
PARAGON 420, CARDIAC MONITOR
K861067 · DPS
Life Sensing Instrument Company, Inc.
Cardiovascular · 77d
Cleared Jun 02, 1986
CARDIOCAP MONITOR
K853953 · DRT
Instrumentarium Corp.
Cardiovascular · 250d
Cleared Jun 02, 1986
THERMORITE MODEL HC-83 HYPO/HYPERTHERMIA UNIT
K854856 · DWJ
Thermorite, Inc.
Cardiovascular · 179d
Cleared Jun 02, 1986
HORIZON 2000 NON-INVASIVE BLOOD PRESSURE CAP.
K854942 · DXN
Mennen Medical, Inc.
Cardiovascular · 174d