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
151537–151560 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 30, 1984
DETECT-A-STREP
K843590 · GTZ
Antibodies, Inc.
Microbiology · 48d
Cleared Oct 30, 1984
RETIC-SET
K843619 · KQC
R&D Systems, Inc.
Hematology · 46d
Cleared Oct 30, 1984
PHOTOMETER 90IYS
K843668 · JJQ
Institute Virion , Ltd.
Microbiology · 43d
Cleared Oct 30, 1984
SIGMA PERIODIC ACID-SCHIFF STAIN 395
K843752 · HZT
Sigma Chemical Co.
Hematology · 35d
Cleared Oct 30, 1984
BETA QUIK V
K843795 · JHI
Pacific Biotech, Inc.
Chemistry · 33d
Cleared Oct 30, 1984
HUMAN SERUM ANTICONVULSANT DRUG CONTROL
K843818 · DIF
Quantimetrix Corp.
Toxicology · 32d
Cleared Oct 30, 1984
PARATHYROID HORMONE MID-MOLECULE RIA-KIT
K843870 · CEW
Diagnostic Products Corp.
Chemistry · 28d
Cleared Oct 30, 1984
PARATHYROID HORMONE C-TERMINAL RIA KIT
K843871 · CEW
Diagnostic Products Corp.
Chemistry · 28d
Cleared Oct 30, 1984
MAGNESIUM REAGENT SET
K843893 · JGJ
Livonia Diagnostics, Inc.
Chemistry · 27d
Cleared Oct 30, 1984
TOTAL CALCIUM REAGENT SET
K843895 · CIC
Livonia Diagnostics, Inc.
Chemistry · 27d
Cleared Oct 30, 1984
COBAS FP TDM CONTROLS
K843913 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 26d
Cleared Oct 30, 1984
TDX REA CREATININE
K843916 · CGX
Abbott Laboratories
Chemistry · 25d
Cleared Oct 30, 1984
SPOTTEST LOEFFLER METHYLENE BLUE STAIN
K843919 · KFC
Difco Laboratories, Inc.
Microbiology · 25d
Cleared Oct 30, 1984
IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I
K843930 · CGJ
Euro-Diagnostics BV
Immunology · 25d
Cleared Oct 30, 1984
LINEAR ENZYMATIC URIC ACID SYSTEM
K843938 · KNK
Simmler, Inc.
Chemistry · 21d
Cleared Oct 30, 1984
PYR BROTH
K843987 · JTO
Remel Co.
Microbiology · 19d
Cleared Oct 30, 1984
FOCUS URIC ACID
K844011 · KNK
Abbott Laboratories
Chemistry · 18d
Cleared Oct 30, 1984
CREATININE REAGENT SET
K844024 · CGX
Livonia Diagnostics, Inc.
Chemistry · 15d
Cleared Oct 30, 1984
URIC ACID REAGENT SET
K844075 · LFQ
Livonia Diagnostics, Inc.
Chemistry · 11d
Cleared Oct 30, 1984
STRAIGHT AND BUBBLE OXYGEN TUBING
K844083 · CAT
Hudson Extrusions, Inc.
Anesthesiology · 11d
Cleared Oct 30, 1984
POLYVINYL CHLORIDE CANNULAS
K844084 · CAT
Hudson Extrusions, Inc.
Anesthesiology · 11d
Cleared Oct 29, 1984
SERVOMED PULSE AMPLIFIER MODULE-206-
K840523 · DRT
Litton Medical Electronics
Cardiovascular · 265d
Cleared Oct 29, 1984
CARDIORHYTHM 2000
K841472 · DSH
Biogenix, Inc.
Cardiovascular · 203d
Cleared Oct 26, 1984
ELECTRONIC BLOOD PRESS. METER EN-212
K832076 · DXN
Panasonic Co. Div. Matsu Elec. Corp....
Cardiovascular · 486d