FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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

Filters: Cardiovascular ×
18,151 results
11713–11736 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 11, 1992
SOFT-TEMP
K921920 · DWJ
Adroit Medical Systems, Inc.
Cardiovascular · 232d
Cleared Dec 10, 1992
TORQUE DEVICE
K922536 · DQX
Procedure Products, Inc.
Cardiovascular · 196d
Cleared Dec 10, 1992
SCIMED SIDELINER
K922706 · DQX
Scimed
Cardiovascular · 188d
Cleared Dec 08, 1992
RMI NORMOCLUDER CORONARY ARTERY OCCLUDER
K915869 · MJN
Research Medical, Inc.
Cardiovascular · 343d
Cleared Dec 08, 1992
IQ SYSTEM
K922218 · DXG
Renaissance Technology, Inc.
Cardiovascular · 210d
Cleared Dec 08, 1992
10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE
K922573 · MAV
Boston Scientific Corp
Cardiovascular · 190d
Cleared Dec 08, 1992
SCHNEIDER SOLID-7 SOPTIP GUIDING CATHETER
K924591 · DQY
Schneider Intl., Ltd.
Cardiovascular · 89d
Cleared Dec 08, 1992
MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT
K924643 · DWF
Medtronic Bio-Medicus, Inc.
Cardiovascular · 85d
Cleared Dec 08, 1992
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM
K924712 · MCW
Hearing Tech, Inc.
Cardiovascular · 81d
Cleared Dec 08, 1992
TAPER GUIDEWIRES
K924987 · DQX
Target Therapeutics
Cardiovascular · 55d
Cleared Dec 07, 1992
PORTABLE PATIENT MONITOR
K922974 · MHX
Hewlett-Packard Co.
Cardiovascular · 168d
Cleared Dec 03, 1992
MEDTRONIC MODELS 5069 AND 5071 MYOCARDIAL PACING
K915736 · DTB
Medtronic Vascular
Cardiovascular · 349d
Cleared Dec 03, 1992
BLUE MAX II BALLOON DDILATATION CATHETER
K921254 · LIT
Boston Scientific Corp
Cardiovascular · 262d
Cleared Dec 03, 1992
COBE SAMPLING SITE
K922484 · DQO
Cobe Cardiovascular, Inc.
Cardiovascular · 190d
Cleared Nov 30, 1992
SORIN MONOLYRH INTEGRATED MEMBRANE LUNG
K922933 · DTZ
Sorin Biomedica, Fiat, USA, Inc.
Cardiovascular · 165d
Cleared Nov 27, 1992
VENA CAVA FILTER SYSTEMS, MODIFICATION
K925679 · DTK
B. Braun Vena-Tech
Cardiovascular · 17d
Cleared Nov 25, 1992
ULTRA LOW POROSITY DACRON WOVEN PATCH
K921659 · DXZ
Intervascular, Inc.
Cardiovascular · 232d
Cleared Nov 25, 1992
IMPRA FLEX GRAFTS (VARIOUS PRODUCT CODE NUMBERS)
K924360 · DYF
Impra, Inc.
Cardiovascular · 89d
Cleared Nov 24, 1992
FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT
K922905 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 161d
Cleared Nov 23, 1992
HOLLOW MOTOR DRIVE UNIT W/ TORQUE CONTROLLER
K920707 · MCW
Devices For Vascular Intervention, Inc.
Cardiovascular · 279d
Cleared Nov 23, 1992
UNIPOLAR ATRIAL TEMPORARY PACING LEAD, MODEL 6492
K922182 · LDF
Medtronic Vascular
Cardiovascular · 196d
Cleared Nov 23, 1992
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD MOD. 6491
K922268 · LDF
Medtronic Vascular
Cardiovascular · 193d
Cleared Nov 23, 1992
UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493
K922269 · LDF
The Heart Valve Div. Medtronic...
Cardiovascular · 193d
Cleared Nov 23, 1992
TUBE GRIP
K922404 · KRI
Georgia Medical Products, Inc.
Cardiovascular · 186d