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
172081–172104 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 31, 1978
NURITE II
K780828 · GZJ
Bio-Medical Systems Corp.
Neurology · 12d
Cleared May 26, 1978
DYNEX BLOOD GAS QUALITY CONTROL SYS.
K780144 · JJS
Analytical Products, Inc.
Chemistry · 122d
Cleared May 26, 1978
SCINTILLATION, LIQUID, RACKBETA
K780341 · JJJ
Lkb Instruments, Inc.
Radiology · 86d
Cleared May 26, 1978
MASSAGER, GUM/SSAGE POWERED GUM
K780360 · JEQ
Sunbeam Corp.
Dental · 81d
Cleared May 26, 1978
TOTAL IRON BINDING CAPACITY
K780412 · JQG
Diagnostic Corp. of America
Chemistry · 72d
Cleared May 26, 1978
ARRHYTHMIA PROGRAM MODULE
K780432 · DSI
Midwest Analog & Digital, Inc.
Cardiovascular · 70d
Cleared May 26, 1978
THERMAJUST CIRCU-TEMP
K780543 · JRQ
Techhnilab Instruments, Inc.
Chemistry · 53d
Cleared May 26, 1978
SR-PLUS DIRECT CHOLESTEROL TEST
K780545 · CGO
Stanbio Laboratory
Chemistry · 53d
Cleared May 26, 1978
BOTTLE BREATHING DEVICE
K780558 · BYO
B & F Medical Products, Inc.
Anesthesiology · 51d
Cleared May 26, 1978
DURAN FLEXIBLE RING
K780568
Hancock Laboratories, Inc.
Cardiovascular · 46d
Cleared May 26, 1978
MASK, ISOLATION
K780609 · FXX
Abco Dealers, Inc.
General Hospital · 46d
Cleared May 26, 1978
CULDOCENTESIS TRAY
K780624 · GAA
Cutter Laboratories, Inc.
General & Plastic Surgery · 42d
Cleared May 26, 1978
VENTURI OXYGEN MASK
K780626 · BYF
Hospitak, Inc.
Anesthesiology · 42d
Cleared May 26, 1978
ACCESSORY HDL CHOLESTEROL REAGENT SET
K780638 · CHH
The Dow Chemical Co.
Chemistry · 38d
Cleared May 26, 1978
FLAME PHOTOMETER, MODEL 435
K780649 · JJO
Corning Medical & Scientific
Chemistry · 37d
Cleared May 26, 1978
FLAME PHOTOMETER, MODEL 455
K780650 · JJO
Corning Medical & Scientific
Chemistry · 37d
Cleared May 26, 1978
MICRO-RING
K780711 · EGG
Howmedica Corp.
Dental · 29d
Cleared May 26, 1978
ADVANCED DENTURE SYSTEM
K780722 · EKO
Advanced Marketing Research Co.
Dental · 25d
Cleared May 26, 1978
SNAP-WAY
K780747 · DZB
Northwest Orthodontics, Inc.
Dental · 18d
Cleared May 26, 1978
PROPHYLAXIS ANGLE
K780752 · EGS
Young Dental Manufacturing Co. 1, LLC
Dental · 18d
Cleared May 26, 1978
EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE
K780762 · DXE
Shiley, Inc.
Cardiovascular · 18d
Cleared May 26, 1978
MODEL 5621A INTERFACE
K780768 · DQK
Hewlett-Packard Co.
Cardiovascular · 21d
Cleared May 26, 1978
TRIGLYCERIDE C-37 RAPID STAT KIT
K780825 · JGY
Pierce Chemical Co.
Chemistry · 7d
Cleared May 26, 1978
BILIRUBIN RAPID STAT KIT
K780826 · CIG
Pierce Chemical Co.
Chemistry · 7d