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
14857–14880 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 25, 1985
MEDI-TRACE DISPOSABLE PRESSURE TRANSDUCER
K850898 · DRS
Medi-Trace Products Division
Cardiovascular · 143d
Cleared Jul 25, 1985
ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251
K853017 · DXY
Ela Medical, Inc.
Cardiovascular · 8d
Cleared Jul 25, 1985
#335-01 SILIC RUB ISOLA SLEEVE FOR INT #281-03 SIZ
K853034 · DXY
Intermedics, Inc.
Cardiovascular · 7d
Cleared Jul 24, 1985
HIGH PRESSURE FLEX. CONNECTING TUBING
K841092 · DXT
Tronomed, Inc.
Cardiovascular · 498d
Cleared Jul 24, 1985
HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA
K844484 · KRG
Vitatron Medical BV
Cardiovascular · 247d
Cleared Jul 24, 1985
COACH TM- THE AEROBIC FITNESS MONITOR
K851335 · DRT
Biotechnology, Inc.
Cardiovascular · 112d
Cleared Jul 24, 1985
ECG MONITOR MODEL RM102
K851496 · DXJ
Honeywell, Inc.
Cardiovascular · 100d
Cleared Jul 24, 1985
MODEL MB-309H, SHARP DIGITAL BLOOD PRESSURE MONITO
K851664 · DXN
Sharp Electronics Corp.
Cardiovascular · 92d
Cleared Jul 19, 1985
DIGITMATIC DM2
K851128 · JOM
Medimatic
Cardiovascular · 121d
Cleared Jul 19, 1985
HOMEDICA CEMENTED ACETABULAR COMPONENT 6262
K851565 · DXQ
Howmedica Corp.
Cardiovascular · 94d
Cleared Jul 19, 1985
PERCUTANEOUS TRANSLUMINAL BLOOD DILATION CATHETER
K851848 · LIT
Mansfield Scientific, Inc.
Cardiovascular · 84d
Cleared Jul 19, 1985
SEA MED DDD PACING SYSTEM ANALYZER
K851900 · DTC
Seamed Corp.
Cardiovascular · 80d
Cleared Jul 19, 1985
SUPRIMA II MODEL 254-26
K852431 · DXY
Intermedics, Inc.
Cardiovascular · 39d
Cleared Jul 17, 1985
SUPRIMA II MODEL 253-23
K852430 · DXY
Intermedics, Inc.
Cardiovascular · 37d
Cleared Jul 17, 1985
SUPRIMA II MODEL 254-28
K852432 · DXY
Intermedics, Inc.
Cardiovascular · 37d
Cleared Jul 16, 1985
MEDTRONIC 5311 PACING SYSTEM ANALYZER
K850077 · DTC
Medtronic Vascular
Cardiovascular · 188d
Cleared Jul 16, 1985
CHRONOCOR V EXTERNAL PACER, MODEL 297A
K850822 · DTE
Seamed Corp.
Cardiovascular · 138d
Cleared Jul 12, 1985
ACCUCOM CARDIAC OUTPUT MONITOR
K851426 · DXK
Lawrence Medical Systems, Inc.
Cardiovascular · 93d
Cleared Jul 12, 1985
SIRECUST 425, RESPECTIVELY SIRECUST 430
K851637 · DQK
Siemens Medical Solutions USA, Inc.
Cardiovascular · 84d
Cleared Jul 12, 1985
SCANLAN TUNNELER, SHEATH & TIP
K851825 · DWS
Scanlan Intl., Inc.
Cardiovascular · 77d
Cleared Jul 11, 1985
KENZ 80Z MARK II
K843731 · DSI
Suzuken Co., Ltd.
Cardiovascular · 290d
Cleared Jul 11, 1985
CARDIAC COOLING JACKET
K851077 · KRI
Pat O. Daily
Cardiovascular · 115d
Cleared Jul 11, 1985
MODEL 483-06 POLYFLEX IMPLANTABLE PACING LEAD
K851457 · DTD
Intermedics, Inc.
Cardiovascular · 91d
Cleared Jul 11, 1985
MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD
K851458 · DTD
Intermedics, Inc.
Cardiovascular · 91d