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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,027 results
10873–10896 of 18,027
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 14, 1995
MEDIFRIEND PROFESSIONAL SPHYGMOMANOMETER
K950778 · DXQ
Shanghai Medifriend Medical Products...
Cardiovascular · 21d
Cleared Mar 13, 1995
ZOLL PD 1600 SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR
K942344 · MKJ
Zoll Medical Corp
Cardiovascular · 301d
Cleared Mar 13, 1995
FLUORO-TIP(R) HEMOSTASIS VALVE INTRODUCER SET
K945396 · DYB
B.Braun Medical, Inc.
Cardiovascular · 130d
Cleared Mar 13, 1995
SCIMED(R) TRIDUIGE(R) GUIDE CATHETERS
K946204 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 82d
Cleared Mar 10, 1995
PRO-SPORT HEART RATE MONITOR
K943242 · DRT
Sensor Dynamics, Inc.
Cardiovascular · 247d
Cleared Mar 10, 1995
PULSE HEART RATE MONITOR
K943243 · DRT
Sensor Dynamics, Inc.
Cardiovascular · 247d
Cleared Mar 08, 1995
NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESSURE MONITOR AND CONNECTED TO THE...
K945947 · DXN
Nellcor, Inc.
Cardiovascular · 92d
Cleared Mar 07, 1995
IMD PSD 410 PACEMAKER TRANSMITTER
K943995 · DXH
Integrated Medical Devices, Inc.
Cardiovascular · 203d
Cleared Mar 03, 1995
CONTROL
K944284 · DQO
Daig Corp.
Cardiovascular · 182d
Cleared Mar 03, 1995
SHERPA SHERPA II AND ASCENT CORONARY GUIDING CATHETERS
K944668 · DQY
Medtronics Interventional Vascular
Cardiovascular · 171d
Cleared Mar 03, 1995
SCIMED CHIOCE PLUS PTCA GUIDE WIRE
K945129 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 135d
Cleared Mar 03, 1995
RMI CIRKUIT-GUARD(TM) PRESSURE RELIEF VALVE
K945931 · DTL
Research Industries Corp.
Cardiovascular · 88d
Cleared Mar 03, 1995
POWERFLEX(TM) 5F PTA BALLOON CATHETER
K946052 · LIT
Cordis Corp.
Cardiovascular · 81d
Cleared Mar 03, 1995
SCIMED 6 FRENCH MICRO-MAX(TM) GUIDE CATHETER
K950094 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 52d
Cleared Mar 01, 1995
DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340
K942700 · MHX
Critikon Company, LLC
Cardiovascular · 266d
Cleared Mar 01, 1995
EK-VIEW(TM) ECG MANAGEMENT SYSTEM
K946115 · DXG
Apcot Medical Systems
Cardiovascular · 76d
Cleared Mar 01, 1995
CANDELA SHEATH SETS
K950634 · DQY
Candela Laser Corp.
Cardiovascular · 16d
Cleared Mar 01, 1995
CANDEKA DUKATIR SETS
K950635 · DQY
Candela Laser Corp.
Cardiovascular · 16d
Cleared Feb 24, 1995
EKG VEST
K932903 · DRX
Cardiotronics, Inc.
Cardiovascular · 618d
Cleared Feb 24, 1995
SILICORE SEMI-FLOATER
K934787 · LDF
Electro-Catheter Corp.
Cardiovascular · 507d
Cleared Feb 24, 1995
DATASCOPE 95 AND 97 IAB PUMP CONSOLE
K942454 · DSP
Datascope Corp.
Cardiovascular · 277d
Cleared Feb 24, 1995
CVD PERIFLOW(TM) BALLOON DILATATION CATHETER
K945943 · LIT
Cardio-Dynamics, Inc.
Cardiovascular · 81d
Cleared Feb 24, 1995
ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT
K946029 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 77d
Cleared Feb 23, 1995
VASOGENICS EECP-MC2
K940264 · DRN
Vasogenics, Inc.
Cardiovascular · 398d