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
12625–12648 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 12, 1990
C.P.R. LANDMARC
K900415 · LIX
Can-Am Medical, Inc.
Cardiovascular · 133d
Cleared Jun 12, 1990
VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458
K901402 · DTB
Telectronics Pacing Systems, Inc.
Cardiovascular · 78d
Cleared Jun 12, 1990
ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDE
K901565 · DXC
Applied Vascular Devices, Inc.
Cardiovascular · 70d
Cleared Jun 12, 1990
7620 REMOTE CENTRAL STATION REPEATER
K901884 · DXJ
Marquette Electronics, Inc.
Cardiovascular · 47d
Cleared Jun 12, 1990
SORBA MODEL CIC-1000 W/NEW ELECTRODES
K901926 · DXG
Sorba Medical Systems, Inc.
Cardiovascular · 43d
Cleared Jun 11, 1990
DYNATRON 330 BODY COMPOSITION ANALYZER
K900321 · DSB
Dynatronics Laser Corp.
Cardiovascular · 139d
Cleared Jun 11, 1990
INSITE STEERABLE GUIDEWIRE
K901224 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 89d
Cleared Jun 11, 1990
PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR
K901249 · DTZ
Shiley, Inc.
Cardiovascular · 87d
Cleared Jun 11, 1990
PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR
K901250 · DTZ
Shiley, Inc.
Cardiovascular · 87d
Cleared Jun 08, 1990
RMI CARDIOPLEGIA DELIVERY KITS
K901231 · DWF
Research Medical, Inc.
Cardiovascular · 86d
Cleared Jun 05, 1990
HORIZON SURGICAL LIGATING AND MARKING CLIP
K901303 · DSS
Horizon Surgical, Inc.
Cardiovascular · 77d
Cleared May 30, 1990
MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS
K901018 · LIT
Boston Scientific Corp
Cardiovascular · 86d
Cleared May 30, 1990
SIEMENS SIRECUST 732, PATIENT MONITOR
K901771 · DPS
Siemens Medical Electronics
Cardiovascular · 41d
Cleared May 23, 1990
FLEXMEDICS GUIDEWIRE .012 ONLY
K895899 · DQX
Flexmedics
Cardiovascular · 229d
Cleared May 22, 1990
ANGIO-MAX
K900034 · DXT
Accumed Systems, Inc.
Cardiovascular · 140d
Cleared May 22, 1990
COBE AIR EMBOLI PROTECTION SYSTEM (AEPS)
K900910 · DTW
Cobe Laboratories, Inc.
Cardiovascular · 84d
Cleared May 22, 1990
MODEL 9101 RECORDER/ANALYZER SYSTEM
K901251 · DSH
Aequitron Medical, Inc.
Cardiovascular · 67d
Cleared May 22, 1990
USCI(R) ACCESS(TM) INTRODUCER SET
K901452 · DYB
C.R. Bard, Inc.
Cardiovascular · 55d
Cleared May 22, 1990
DNP 60-B UNIPOLAR ENDOCARDIAL LEAD
K901709 · DTB
Biotronik, GmbH & Co.
Cardiovascular · 39d
Cleared May 17, 1990
EXTRACORPOREAL HEAT EXCHANGER HE SERIES
K896020 · DTR
Gish Biomedical, Inc.
Cardiovascular · 213d
Cleared May 17, 1990
VOSS DISPOSABLE CORONARY BYPASS FLUSHING CANNULA
K896338 · DWF
Voss Medical Products
Cardiovascular · 195d
Cleared May 17, 1990
PCI MODEL 2041-B TELEMETRY MONITOR
K896775 · DSI
Accucore, Inc.
Cardiovascular · 167d
Cleared May 17, 1990
MODEL 215M PATIENT SIMULATOR
K897074 · DSI
Dynatech/Nevada, Inc.
Cardiovascular · 146d
Cleared May 17, 1990
HEPARINIZED ARTERIAL SCREEN BLOOD FILTER
K900758 · DTM
Cobe Laboratories, Inc.
Cardiovascular · 90d