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
154921–154944 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 03, 1984
FERTITUBE PREGNANCY TEST #1120
K832867 · JHJ
Stanbio Laboratory
Chemistry · 163d
Cleared Feb 03, 1984
QUALITATIVE ENZYME IMMUNOASSAY-DETECT
K832905 · LCX
Btc Diagnostics, Inc.
Chemistry · 158d
Cleared Feb 03, 1984
LABELED 125I ANTI-IGE
K833419 · DGC
Allergenetics
Immunology · 123d
Cleared Feb 03, 1984
RADOVAN SUBCUTANEOUS TISSUE EXPANDER
K833502 · LCJ
American Heyer Schulte
General & Plastic Surgery · 121d
Cleared Feb 03, 1984
VISIO-GEM
K833757 · EBF
Espe GmbH (Us)
Dental · 100d
Cleared Feb 03, 1984
WHITE BLOOD CELLS HUMAN TAND B
K833929 · LIZ
Control Diagnostics
Hematology · 108d
Cleared Feb 03, 1984
VENTREX PREGNANCY TEST KIT ENZYME
K833960 · JHI
Vxr, Inc.
Chemistry · 79d
Cleared Feb 03, 1984
TANDEM VISUAL HCG IMMUNOENZYMETRIC
K834000 · JHI
Hybritech, Inc.
Chemistry · 74d
Cleared Feb 03, 1984
LUXENE VINYL-JECT 3600-80
K834046 · EBF
Howmedica Corp.
Dental · 72d
Cleared Feb 03, 1984
SCHEIN COTTON ROLLS, NON-STERILE
K834056 · EFN
Henry Schein, Inc.
Dental · 72d
Cleared Feb 03, 1984
MAGNESIUM B TEST
K834075 · JGJ
Wako Chemicals USA, Inc.
Chemistry · 70d
Cleared Feb 03, 1984
CONTACT-K APTT REAGENT
K834086 · GGN
Pacific Hemostasis
Microbiology · 67d
Cleared Feb 03, 1984
BLOOD GLUCOSE MONITOR
K834099 · JJQ
Healthdyne, Inc.
Hematology · 67d
Cleared Feb 03, 1984
ANTACHE ANTI-HEADACHE DEVICE
K834111 · HCC
Bio Sig Instruments, Inc.
Neurology · 66d
Cleared Feb 03, 1984
ALEXOLOK BRACKET
K834272 · EJF
Alexotek Co.
Dental · 57d
Cleared Feb 03, 1984
IMMUNO-CRP
K834390 · DCN
Immunostics Co., Inc.
Microbiology · 51d
Cleared Feb 03, 1984
IMMUNO-RA
K834391 · DHR
Immunostics Co., Inc.
Microbiology · 51d
Cleared Feb 03, 1984
LIQUI-SERA TDM CALIBRATORS
K834398 · DKB
Biodiagnostic Intl
Toxicology · 51d
Cleared Feb 03, 1984
EMIT QST PHENYTOIN ASSAY
K834406 · DIP
Syva Co.
Toxicology · 51d
Cleared Feb 03, 1984
MUELLER-HINTON AGAR PLATE
K834421 · JTZ
Otisville Biotech, Inc.
Microbiology · 50d
Cleared Feb 03, 1984
TDX PROCAINAMIDE
K834464 · LAR
Abbott Laboratories
Toxicology · 45d
Cleared Feb 03, 1984
DNASE AGAR W/TOLUDINE BLUE PLATE
K840071 · JSH
Otisville Biotech, Inc.
Microbiology · 25d
Cleared Feb 03, 1984
ESCULIN AGAR PLATE
K840073 · JSH
Otisville Biotech, Inc.
Microbiology · 25d
Cleared Feb 03, 1984
TRYPTICASE SOY BROTH TUBE
K840075 · JSG
Otisville Biotech, Inc.
Microbiology · 25d