Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
40705–40728 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 2013
CHEMOLOCK, CHEMOLOCK PORT
K131549 · ONB
Icu Medical, Inc.
General Hospital · 58d
Cleared Jul 26, 2013
EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM
K131595 · JJY
Eurotrol B.V.
Chemistry · 53d
Cleared Jul 26, 2013
AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER
K131814 · MSD
Ameco Medical Industries
Gastroenterology & Urology · 36d
Cleared Jul 26, 2013
CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST
K131931 · LCX
Chemtron Biotech, Inc.
Chemistry · 29d
Cleared Jul 26, 2013
HBA1C CONTROL, LEVEL 1 AND LEVEL 2
K131999 · JJX
Randox Laboratories, Ltd.
Chemistry · 28d
Cleared Jul 25, 2013
CAPSTONE(R) SPINAL SYSTEM
K123027 · MAX
Medtronic Sofamor Danek, Inc.
Orthopedic · 300d
Cleared Jul 25, 2013
CARE SU01A SUCTION ASPIRATOR
K130001 · JCX
Foshan Care Medical Technology Co., Ltd.
General & Plastic Surgery · 204d
Cleared Jul 25, 2013
M-SCAN
K130158 · KZM
Bio-Research Associates, Inc.
Dental · 183d
Cleared Jul 25, 2013
COMPRESSYN BAND
K130431 · JDQ
Dallen Medical, Inc.
Orthopedic · 154d
Cleared Jul 25, 2013
DUOFLEX COIL SUITE (1.5T)
K130706 · MOS
Mr Instruments, Inc.
Radiology · 132d
Cleared Jul 25, 2013
HAMMERTOE CORRECTION SYSTEM
K130859 · HWC
Arthrosurface, Inc.
Orthopedic · 119d
Cleared Jul 25, 2013
SMARTRELIEF
K131159 · NUH
Chattem, Inc.
Neurology · 92d
Cleared Jul 25, 2013
BARRICADE EMBOLIZATION COIL SYSTEM
K131475 · HCG
Blockade Medical
Neurology · 64d
Cleared Jul 25, 2013
IQQA-LIVER MULTIMODALITY SOFTWARE
K131498 · LLZ
Edda Technology, Inc.
Radiology · 62d
Cleared Jul 25, 2013
JONES-FX FRACTURE SYSTEM
K131620 · HWC
Instratek, Inc.
Orthopedic · 52d
Cleared Jul 25, 2013
SENSIS, SENSIS LITE
K131812 · DQK
Siemens Medi Cal Solutions, Inc.
Cardiovascular · 36d
Cleared Jul 25, 2013
HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM)
K131974 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 27d
Cleared Jul 24, 2013
EDWARDS EMBOL-X INTRODUCER SHEATH
K123714 · DYB
Edwards Lifesciences, LLC
Cardiovascular · 232d
Cleared Jul 24, 2013
MTA CEMENTS
K130125 · KIF
S&C Polymer Silicon- Und Composite...
Dental · 188d
Cleared Jul 24, 2013
LINA BIPOLAR LOOP
K130305 · HIN
Lina Medical Aps
Obstetrics & Gynecology · 169d
Cleared Jul 24, 2013
POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL
K130667 · LYY
Preventive Care, Inc.
General Hospital · 134d
Cleared Jul 24, 2013
R&D 5D RETIC HEMATOLOGY CONTROL
K130962 · JPK
R&D Systems, Inc.
Hematology · 107d
Cleared Jul 24, 2013
XPERGUIDE
K131263 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 82d
Cleared Jul 24, 2013
REFORM PEDICLE SCREW SYSTEM
K131343 · MNI
Spinal USA
Orthopedic · 76d