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
159745–159768 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 30, 1982
AUTO PERIOMETER 3000
K822580 · HPT
Dicon, Inc.
Ophthalmic · 36d
Cleared Sep 30, 1982
FIXATION MONITOR
K822601 · HPT
West Coast Optical Instruments, Inc.
Ophthalmic · 34d
Cleared Sep 30, 1982
T3 UPTAKE KITS
K822612 · KHQ
Pcl-Ria, Inc.
Chemistry · 31d
Cleared Sep 30, 1982
QUANTAPHOS ACID PHOSPHATOSE CONT. SERUM
K822646 · JJT
Beckman Instruments, Inc.
Chemistry · 28d
Cleared Sep 30, 1982
SUPER DONUT
K822650 · KME
Alimed, Inc.
General Hospital · 28d
Cleared Sep 30, 1982
YEAST ASSIMILATION BROTH
K822694 · JSF
Granite Diagnostics, Inc.
Microbiology · 23d
Cleared Sep 30, 1982
GLUCOSCAN TEST STRIPS
K822697 · CGA
Lifescan, Inc.
Chemistry · 23d
Cleared Sep 30, 1982
GLUCOSCAN CONTROLS
K822698 · JJX
Lifescan, Inc.
Chemistry · 23d
Cleared Sep 30, 1982
V AGAR
K822702 · JSH
Granite Diagnostics, Inc.
Microbiology · 23d
Cleared Sep 30, 1982
PLATELET CENTRIFUGE
K822715 · JQC
Biodynamics Corp.
Hematology · 23d
Cleared Sep 30, 1982
UNIVERSAL CENTRIFUGE
K822716 · JPI
Biodynamics Corp.
Hematology · 23d
Cleared Sep 30, 1982
CROWN S BRIDGE RESIN
K822722 · EBG
Rohm and Haas Co.
Dental · 23d
Cleared Sep 30, 1982
THE SCREENING TYMPANOMETER
K822745 · EWO
American Electromedics Corp.
Ear, Nose, Throat · 20d
Cleared Sep 30, 1982
DELIVERY TUBE SET #2226
K822761 · FRN
Delta Medical Industries
General Hospital · 16d
Cleared Sep 30, 1982
NUDA-PLUS CONDOM W/SPERMICIDAL LUBRICANT
K822792 · HIS
Ansell, Inc.
Obstetrics & Gynecology · 15d
Cleared Sep 30, 1982
MEDICAL LABS FETAL SCAN #1000 W/CENTRAL
K822830 · HGM
Cranbury Medical Labs, Inc.
Obstetrics & Gynecology · 9d
Cleared Sep 29, 1982
UNKNOWN
K827454
Ote Biomedica
Radiology · 57d
Cleared Sep 29, 1982
STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE
K827583 · IWB
Nucletronix, Inc.
Radiology · 30d
Cleared Sep 29, 1982
ULTRASONIC PULSED ECHO IMAGING SYSTEM RT30
K827891
General Electric Co.
Radiology · 49d
Cleared Sep 29, 1982
VRT TABLE
K827928 · IZZ
General Electric Co.
Radiology · 43d
Cleared Sep 29, 1982
ADR ULTRASOUND MC2 LARGE CART
K828049
Adr Ultrasound
Radiology · 29d
Cleared Sep 29, 1982
ADR ULTRASOUND MODEL 4000 L
K828050
Adr Ultrasound
Radiology · 29d
Cleared Sep 29, 1982
ADR ULTRASOUND MODEL 4000 SC OR 4000 S/LC
K828051
Adr Ultrasound
Radiology · 29d
Cleared Sep 29, 1982
ADR ULTRASOUND 5.5 MHZ SHORT FOCUS TRANSDUCER
K828053
Adr Ultrasound
Radiology · 29d