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
159553–159576 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 1982
ANAEROBIC CARBON DIOXIDE
K822752 · BXK
Liquid Carbonic Corp.
Anesthesiology · 39d
Cleared Oct 22, 1982
BLOOD GAS MIXTURE
K822753 · BXK
Liquid Carbonic Corp.
Anesthesiology · 39d
Cleared Oct 22, 1982
CLINICAL GAS MIXTURE-FLAMMABLE
K822762 · BXK
Liquid Carbonic Corp.
Anesthesiology · 38d
Cleared Oct 22, 1982
CLINICAL GAS MIXTURE-NON-FLAMMABLE
K822763 · BXK
Liquid Carbonic Corp.
Anesthesiology · 38d
Cleared Oct 22, 1982
LUNG DIFFUSION MIXTURE
K822764 · BXK
Liquid Carbonic Corp.
Anesthesiology · 38d
Cleared Oct 22, 1982
MICRO-CRAFT OSCILLATING SAW HANDPIECE
K822790 · KIJ
Xomed, Inc.
Orthopedic · 37d
Cleared Oct 22, 1982
PIO ROOT CANAL INDICATOR
K822793 · EIL
National Patent Development Corp.
Dental · 36d
Cleared Oct 22, 1982
RESPIRONICS ENDO TUBE CONTROL SYS
K822794 · CBH
Respironics, Inc.
Anesthesiology · 36d
Cleared Oct 22, 1982
MODEL 700 GASTROREFLUX MONITOR/AMALYZER
K822815 · FFT
Del Mar Avionics
Gastroenterology & Urology · 32d
Cleared Oct 22, 1982
DUAL SERVO HEATED RESPIRATORY HUMIDIFIER
K822816 · BTT
Fisher & Paykel Allied Products , Ltd.
Anesthesiology · 32d
Cleared Oct 22, 1982
PENTAX FC-38LA & FC-38SA COLONOFIBER
K822846 · FDF
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 29d
Cleared Oct 22, 1982
MODEL BX-3000 OXYGEN CONCENTRATOR
K822871 · CAW
Healthdyne, Inc.
Anesthesiology · 25d
Cleared Oct 22, 1982
MODEL #6200 OXYGEN CONCENTRATOR
K822889 · CAW
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 24d
Cleared Oct 22, 1982
G.E.V. DISPOSABLE SCALPELS
K822893 · GDX
Ascep, Inc.
General & Plastic Surgery · 24d
Cleared Oct 22, 1982
CAVIDRY
K822896 · EJH
Parker Laboratories, Inc.
Dental · 23d
Cleared Oct 22, 1982
ANAZYME ANA PEROXIDASE TEST SYSTEM
K822911 · DAA
Clinical Sciences, Inc.
Immunology · 21d
Cleared Oct 22, 1982
RX BIOCAST
K822948 · EJH
Jeneric Ind.
Dental · 18d
Cleared Oct 22, 1982
RX SFC
K822949 · EJT
Jeneric Ind.
Dental · 18d
Cleared Oct 22, 1982
RX UNIVERSAL
K822950 · EJS
Jeneric Ind.
Dental · 18d
Cleared Oct 22, 1982
ENDOSCOPIC VIDEOSYSTEM
K822959 · FET
Eder Instrument Co, Inc.
Gastroenterology & Urology · 17d
Cleared Oct 21, 1982
BECKMAN ASTRA
K822039 · JGS
Beckman Instruments, Inc.
Chemistry · 101d
Cleared Oct 21, 1982
AMNISTAT-FLM
K822150 · JHG
Hana Biologics, Inc.
Hematology · 91d
Cleared Oct 21, 1982
DESERET ARTERIAL BLOOD SAMPLING KIT
K822248 · CBT
Warner-Lambert Co.
Anesthesiology · 84d
Cleared Oct 21, 1982
NEW ENZYMATIC SINGLE REAGENT FREE CHOL.
K822417 · CHH
Sclavo, Inc.
Chemistry · 71d