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
11089–11112 of 18,027
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 15, 1994
PACING LEAD MODEL 1188T
K925038 · DTB
Siemens-Pacesetter, Inc.
Cardiovascular · 648d
Cleared Jul 12, 1994
CORDIS OPTA 5(TM) PTA BALLOON CATHETER, MODIFICATION
K940868 · LIT
Cordis Corp.
Cardiovascular · 140d
Cleared Jul 11, 1994
CARDIAC CATHETERIZATION TRAY
K931560 · DQO
Clinipad Corp.
Cardiovascular · 468d
Cleared Jul 11, 1994
PROCATH PACING THRESHOLD CABLE
K941058 · DSA
Professional Catheter Corp.
Cardiovascular · 125d
Cleared Jul 07, 1994
EVERT-O-CATH CATHETER
K922455 · DQO
American Biomaterials Corp.
Cardiovascular · 776d
Cleared Jul 07, 1994
3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE
K934333 · DRX
3M Medical Products Group
Cardiovascular · 303d
Cleared Jul 07, 1994
VASCU-GUARD
K942010 · DXZ
Bio-Vascular, Inc.
Cardiovascular · 73d
Cleared Jul 06, 1994
PASSIVE PLUS ENDOCARDIAL PACING LEADS VAR. MODELS
K932892 · DTB
Siemens-Pacesetter, Inc.
Cardiovascular · 387d
Cleared Jul 06, 1994
OMNI-CENTRAL STATION MONITOR
K936051 · DRT
Invivo Research, Inc.
Cardiovascular · 198d
Cleared Jul 06, 1994
EXACTA PERCUTANEOUS INTRODUCER SHEATH
K941428 · DYB
Ohmeda Medical
Cardiovascular · 104d
Cleared Jul 06, 1994
CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE
K942736 · DTJ
Carbomedics, Inc.
Cardiovascular · 26d
Cleared Jul 05, 1994
ADVANCE PRESSURE MONITOR/HIGH PRESSURE LINES
K911884 · DTL
Advance Medical Designs, Inc.
Cardiovascular · 1163d
Cleared Jul 01, 1994
HAND ANEROID SPHYGMOMANOMETER
K940493 · DXQ
Welch Allyn, Inc.
Cardiovascular · 149d
Cleared Jun 29, 1994
IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER
K941404 · DRL
Hogan & Hartson
Cardiovascular · 98d
Cleared Jun 28, 1994
AVECOR PRE-BYPASS FILTER
K940126 · KRJ
Avecor Cardiovascular, Inc.
Cardiovascular · 169d
Cleared Jun 22, 1994
ZIPPREP ELECTRODE
K940802 · DRX
Aspect Medical Systems, Inc.
Cardiovascular · 120d
Cleared Jun 22, 1994
SCIMED TRIGUIDE GUIDING CATHETER
K941137 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 104d
Cleared Jun 20, 1994
620CSR DISPLAY DRIVER
K932894 · DXJ
Vidco, Inc.
Cardiovascular · 371d
Cleared Jun 20, 1994
AFFINITY CVR
K936003 · DTN
Avecor Cardiovascular, Inc.
Cardiovascular · 186d
Cleared Jun 20, 1994
HAND CONTROLLED SYRINGE
K942329 · DQO
Abbott Laboratories
Cardiovascular · 35d
Cleared Jun 17, 1994
PLATINUM PLUS GUIDEWIRE
K935997 · DQX
Boston Scientific Corp
Cardiovascular · 184d
Cleared Jun 15, 1994
SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T
K930876 · DTB
Siemens-Pacesetter, Inc.
Cardiovascular · 481d
Cleared Jun 14, 1994
PRESSURE MONITORING EXTENSION
K942482 · DQO
Surgical Technologies, Inc.
Cardiovascular · 20d
Cleared Jun 13, 1994
DYE MANAGEMENT SYSTEM
K941254 · DQO
Abbott Laboratories
Cardiovascular · 94d