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
16441–16464 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 27, 1981
ELECTRODE, PACEMAKER, PERMANENT
K810139 · DTB
Pacesetter Systems
Cardiovascular · 310d
Cleared Nov 27, 1981
PACEPATH IMPLANT. ENDOCARD. PACING LEAD
K810286 · DTB
Pacesetter Systems
Cardiovascular · 298d
Cleared Nov 27, 1981
GEL ELECTRODE
K813013 · DRX
Arndt Automation & Assoc.
Cardiovascular · 31d
Cleared Nov 27, 1981
POLYSTAN HEART LUNG MACHINE SYS
K813034 · DTQ
Advocacy International, Ltd.
Cardiovascular · 30d
Cleared Nov 27, 1981
POLYSTAN VERTICLUDE BLOOD PUMP
K813035 · DWB
Advocacy International, Ltd.
Cardiovascular · 30d
Cleared Nov 27, 1981
CARDIOBEEPER MEMORY MONITOR
K813101 · DXY
Survival Technology, Inc.
Cardiovascular · 24d
Cleared Nov 27, 1981
EPC FILTER
K813123 · DRR
Codman & Shurtleff, Inc.
Cardiovascular · 23d
Cleared Nov 27, 1981
INTERFACE ARTERIAL BLOOD FILTER
K813131 · DTM
Medical, Inc.
Cardiovascular · 22d
Cleared Nov 27, 1981
VYGON EXTENSION TUBES & CONNECTORS
K813140 · DQO
Exco, Inc.
Cardiovascular · 22d
Cleared Nov 27, 1981
VYGON STOPCOCKS & RAMPS(MANIFOLDS)
K813141 · DTL
Exco, Inc.
Cardiovascular · 22d
Cleared Nov 27, 1981
LEADER-CATH
K813142 · DQO
Exco, Inc.
Cardiovascular · 22d
Cleared Nov 27, 1981
DESILET
K813143 · DYB
Exco, Inc.
Cardiovascular · 22d
Cleared Nov 27, 1981
INTRAFLON, INTRAFLUX, INTRAVALVE
K813144 · DQR
Exco, Inc.
Cardiovascular · 22d
Cleared Nov 24, 1981
COOLEY 2 VASCULAR PROSTHESIS STRAIGHT
K812248 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 105d
Cleared Nov 16, 1981
PRUITT ARTERIAL OCCLUSION CHOLANG. CATH
K812111 · DYG
Bionomy, Inc.
Cardiovascular · 112d
Cleared Nov 16, 1981
ULTRA COM
K812209 · DXK
Ultranamics, Inc.
Cardiovascular · 104d
Cleared Nov 16, 1981
SYNTHEMED PULSE GENERATOR VVI MODEL 1000
K812464 · DXY
Synthemed Corp.
Cardiovascular · 77d
Cleared Nov 16, 1981
DIAGNOSTIC MEDICAL COMPUTER
K812638 · DXG
Diagnostic Resources, Inc.
Cardiovascular · 62d
Cleared Nov 16, 1981
SKI 5000
K812646 · DXK
Smithkline Diagnostics, Inc.
Cardiovascular · 60d
Cleared Nov 16, 1981
MODEL 5867-12 BIPOLAR LOW-PROFILE LEAD
K812725 · LDF
Medtronic Vascular
Cardiovascular · 49d
Cleared Nov 16, 1981
MODEL 535-03 TRACE A PACE
K812755 · DXH
Intermedics, Inc.
Cardiovascular · 47d
Cleared Nov 16, 1981
MODEL 2000 MONITOR
K812828 · DRT
Datascope Corp.
Cardiovascular · 39d
Cleared Nov 16, 1981
FOGARTY FLEXIBLE PROBE
K812935 · DWP
American Edwards Laboratories
Cardiovascular · 27d
Cleared Nov 16, 1981
MILLAR MIKRO-TIP CATHETER PRESSURE TRAN.
K812944 · DRF
Millar Instruments, Inc.
Cardiovascular · 27d