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
16393–16416 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 15, 1982
NORTON MANIFOLD
K820864 · DTL
Norton Performance Plastics Corp.
Cardiovascular · 17d
Cleared Apr 15, 1982
MARQUETTE OPTION II ECG ANALYSIS COMPUT
K820885 · LOS
Marquette Electronics, Inc.
Cardiovascular · 16d
Cleared Apr 14, 1982
FLEX-E1 ECG ELECTRODE
K820579 · DRS
Conmedcorp
Cardiovascular · 42d
Cleared Apr 14, 1982
ARROW M.I.S. MULTI-LUMEN CATHETERIZA
K820648 · DQY
Arrow Intl., Inc.
Cardiovascular · 36d
Cleared Apr 14, 1982
SAMM
K820828 · DXH
Dart Medical Equipment
Cardiovascular · 19d
Cleared Apr 14, 1982
PERCOR PERCUTANEOUS INTRODUCER
K820834 · DYB
Datascope Corp.
Cardiovascular · 19d
Cleared Apr 09, 1982
TRANSTHORACIC TEMP. PACEMAKER #100TPE
K820232 · LDF
Trans Pace, Inc.
Cardiovascular · 71d
Cleared Apr 09, 1982
CATHETER GUIDE WIRE
K820699 · DQX
Quest Medical, Inc.
Cardiovascular · 25d
Cleared Apr 09, 1982
BIOPOLAR TINED ENDOCARDIAL LEAD 403B/60
K820767 · DTB
Siemens Elema AB
Cardiovascular · 18d
Cleared Apr 09, 1982
IMPLANTABLE, MULTIPROGRAMMABLE
K820774 · DXY
Biotronik Sales, Inc.
Cardiovascular · 17d
Cleared Apr 09, 1982
QUANTUM MODELS 253-09, 254-09 254-10
K820853 · DXY
Intermedics, Inc.
Cardiovascular · 14d
Cleared Apr 01, 1982
AUTOMATED BLOOD PRESSURE SPHYGMOMANOMTR
K813522 · DXN
Vitar
Cardiovascular · 106d
Cleared Apr 01, 1982
OLLI 565
K820540 · DRT
Kone Instruments, Inc.
Cardiovascular · 30d
Cleared Apr 01, 1982
CM10 CENTRAL MONITORING SYSTEM
K820671 · DRT
Medtel Pty. , Ltd.
Cardiovascular · 21d
Cleared Apr 01, 1982
NEONATAL INTRODUCER KIT
K820710 · DYB
Norton Performance Plastics Corp.
Cardiovascular · 14d
Cleared Apr 01, 1982
DIASCOPE 2
K820745 · DRT
Puritan Bennett Corp.
Cardiovascular · 13d
Cleared Mar 31, 1982
DATASCOPE MODIFIED #82 IABP SYSTEM
K813182 · DSP
Datascope Corp.
Cardiovascular · 139d
Cleared Mar 26, 1982
CARDIOVASCULAR TEMP. PACEMAKER ELEC
K820003 · LDF
Diag Corp.
Cardiovascular · 81d
Cleared Mar 26, 1982
ADAPTAID TEMP. PACING EXT. LEAD #366-02
K820268 · DSA
Intermedics, Inc.
Cardiovascular · 52d
Cleared Mar 25, 1982
ELECTRONIC DIGITAL SPHYGMOMANOMETER
K820300 · DXN
Copal, Inc.
Cardiovascular · 49d
Cleared Mar 25, 1982
ATRAC TM MULTIPURPOSE BALLOON CATHETER
K820646 · DXE
Atrium Medical Corp.
Cardiovascular · 16d
Cleared Mar 25, 1982
OPTICATH
K820674 · DQE
Oximetrix, Inc.
Cardiovascular · 14d
Cleared Mar 25, 1982
TOUCH FLUSH W/Y TRANSDUCER CONNECTOR
K820676 · DRS
Norton Performance Plastics Corp.
Cardiovascular · 14d
Cleared Mar 25, 1982
TOUCH FLUSH CONTINUOUS FAST/FLUSH
K820677 · DRS
Norton Performance Plastics Corp.
Cardiovascular · 14d