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
154681–154704 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 1984
OMYL -ARDE- SPECTACLE FRAME
K833401 · HQZ
I.J. Langleb , Ltd.
Ophthalmic · 144d
Cleared Feb 21, 1984
BIOREM 3000 & 4000
K833454 · LIL
Biorem
Gastroenterology & Urology · 146d
Cleared Feb 21, 1984
DISPOSABLE I/A HANDPIECE
K833784 · HQC
CooperVision, Inc.
Ophthalmic · 116d
Cleared Feb 21, 1984
CURAY-MATCH PAINT-ON COMPOSITE RESTOR
K833810 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 111d
Cleared Feb 21, 1984
DIGITAL AUDIOMETER/HEARING AID 3100
K833883 · EWO
Frye Electronics, Inc.
Ear, Nose, Throat · 104d
Cleared Feb 21, 1984
NITROGLYCERIN I.V. ADMINISTRATION SET
K833939 · FPA
Critikon Company, LLC
General Hospital · 98d
Cleared Feb 21, 1984
VANADIUM EXCAVATORS SIZES 0-6
K834055 · EKC
Henry Schein, Inc.
Dental · 90d
Cleared Feb 21, 1984
INSTRUMENT, DENTAL
K834072 · EMS
Venture Technology, Inc.
Dental · 88d
Cleared Feb 21, 1984
PRE-CALIBRATED PIPETTES
K834100 · JRC
Vitex
Chemistry · 83d
Cleared Feb 21, 1984
HYBRITECH DATA STATION
K834300 · JQP
Hybritech, Inc.
Chemistry · 74d
Cleared Feb 21, 1984
ULTRASOUND SCANNER XL
K834307 · IYO
Interad Systems, Inc.
Radiology · 110d
Cleared Feb 21, 1984
FLOW-PAC CHLORIDE REAGENT SET
K834333 · CHJ
American Research Products Co.
Chemistry · 71d
Cleared Feb 21, 1984
FLOW-PAC CALCIUM REAGENT SET
K834336 · CIC
American Research Products Co.
Chemistry · 71d
Cleared Feb 21, 1984
LEECO T3-QUANT DIAG. KIT
K834348 · CDP
Leeco Diagnostics, Inc.
Chemistry · 70d
Cleared Feb 21, 1984
DIRECT IRON REAGENT SET
K834396 · CFM
Seragen Diagnostics, Inc.
Chemistry · 69d
Cleared Feb 21, 1984
CROWN & BRIDGE RESIN
K834435 · EBI
Rohm and Haas Co.
Dental · 64d
Cleared Feb 21, 1984
SERIES OF DIAGNOSTIC PHANTOMS
K834465 · IXG
Cirs, Inc.
Radiology · 63d
Cleared Feb 21, 1984
CHICK/REISON PATIENT EMERG. TROLLEY
K834478 · KXJ
Professional Medical Products, Inc.
Radiology · 63d
Cleared Feb 21, 1984
CRONEX SR-337
K834484 · EAM
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 82d
Cleared Feb 21, 1984
FLEXIBLE LIQUID LIGHT GUIDE
K834487 · FFS
Endo Lase, Inc.
Gastroenterology & Urology · 70d
Cleared Feb 21, 1984
SPECTRUM X-RAY CORP
K834494 · IZZ
Spectrum X-Ray Corp.
Radiology · 69d
Cleared Feb 21, 1984
ISOREX LS-36
K834496 · IZI
Elscint, Inc.
Radiology · 75d
Cleared Feb 21, 1984
PROFILE URODYNAMIC MONITORING SYS
K834503 · FAP
Browne Medical, Inc.
Gastroenterology & Urology · 62d
Cleared Feb 21, 1984
SANDMILL RMS
K834512 · FFT
Sandhill Scientific, Inc.
Gastroenterology & Urology · 62d