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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
78313–78336 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 2001
GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE
K013147 · JJX
Bionostics, Inc.
Chemistry · 34d
Cleared Oct 24, 2001
PASS SPINAL SYSTEM
K013191 · MNI
Encore Orthopedics, Inc.
Orthopedic · 30d
Cleared Oct 24, 2001
MODIFIED 650 MAMMOGRAPHY SYSTEM
K013290 · IZH
Lorad, A Hologic Co.
Radiology · 22d
Cleared Oct 23, 2001
HUMI-FLOW, MODEL 6-850-00/ 01/02
K010053 · HIF
Northgate Technologies, Inc.
Obstetrics & Gynecology · 288d
Cleared Oct 23, 2001
TELEPRESS III BLOOD PRESSURE MONITOR, MODEL TPIII
K011058 · DXN
Meridian Medical Technologies , Ltd.
Cardiovascular · 200d
Cleared Oct 23, 2001
ERO50, ORDER-NO.: 2070
K012838 · EJT
Wieland Edelmetalle GmbH & Co.
Dental · 61d
Cleared Oct 23, 2001
EURO 45, ORDER-NO.: 2064
K012840 · EJS
Wieland Edelmetalle GmbH & Co.
Dental · 61d
Cleared Oct 23, 2001
MODIFICATION TO: HL168W TOUCH SCREEN
K013033 · DXN
Health & Life Co., Ltd.
Cardiovascular · 43d
Cleared Oct 23, 2001
MODIFICATION TO BRAIDED GUIDING INTRODUCER
K013202 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 28d
Cleared Oct 23, 2001
POINT 4 FLOWABLE 2
K013325 · EBF
Kerr Dental Materials Center
Dental · 18d
Cleared Oct 22, 2001
MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER
K011392 · MSS
Micra Instruments
Ophthalmic · 168d
Cleared Oct 22, 2001
CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM
K011502 · DZE
Crystal-Seal Dental Implants
Dental · 159d
Cleared Oct 22, 2001
AMEDITECH IMMUTEST DRUG SCREEN THC
K011813 · LDJ
Ameditech, Inc.
Toxicology · 133d
Cleared Oct 22, 2001
AMEDITECH IMMUTEST DRUG SCREEN COC
K011814 · DIO
Ameditech, Inc.
Toxicology · 133d
Cleared Oct 22, 2001
SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY)
K012453 · HBC
Sodemsystems
Neurology · 82d
Cleared Oct 22, 2001
SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)
K012457 · HBC
Sodemsystems
Neurology · 82d
Cleared Oct 22, 2001
METAL SCREW ANCHOR
K012503 · MBI
Biomet Manufacturing, Inc.
Orthopedic · 80d
Cleared Oct 22, 2001
ICE
K012528 · EBF
Southern Dental Industries, Ltd.
Dental · 77d
Cleared Oct 22, 2001
ROK
K012529 · EBF
Southern Dental Industries, Ltd.
Dental · 77d
Cleared Oct 22, 2001
REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS
K012625 · GEI
Alliance Medical Corp.
General & Plastic Surgery · 70d
Cleared Oct 22, 2001
NAVIGUS II MR
K012719 · HAW
Image-Guided Neurologics, Inc.
Neurology · 69d
Cleared Oct 22, 2001
ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS
K012777 · JZO
Bayer Corp.
Immunology · 63d
Cleared Oct 22, 2001
D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM
K012821 · HRN
Dutch Ophthalmic USA, Inc.
Ophthalmic · 60d
Cleared Oct 22, 2001
COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER
K012955 · NEU
Bioform, Inc.
General & Plastic Surgery · 48d