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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
40105–40128 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 2013
SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE...
K130331 · MVN
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 165d
Cleared Jul 26, 2013
DENTAL UNIT WITH CHAIR
K130410 · EIA
Xianyang North West Medical...
Dental · 157d
Cleared Jul 26, 2013
SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS
K130478 · MAX
Globus Medical, Inc.
Orthopedic · 151d
Cleared Jul 26, 2013
CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2...
K130500 · CEF
Sebia
Immunology · 150d
Cleared Jul 26, 2013
BARRX CHANNEL RFA ENDOSCOPIC CATHETER
K130623 · KNS
Covidien, LLC
Gastroenterology & Urology · 140d
Cleared Jul 26, 2013
ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS
K130680 · EBI
Dentsoll, Inc.
Dental · 135d
Cleared Jul 26, 2013
SEER 1000
K130785 · MWJ
Getemed Medizin- Und...
Cardiovascular · 127d
Cleared Jul 26, 2013
ZIRMON SERIES
K131117 · EIH
Kuwotech Co., Ltd.
Dental · 95d
Cleared Jul 26, 2013
KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS
K131264 · HWC
Gebr. Brasseler GmbH & Co. KG
Orthopedic · 84d
Cleared Jul 26, 2013
3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND...
K131448 · LLZ
Koelis
Radiology · 67d
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