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
152353–152376 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 17, 1984
LITHIUM REAGENT
K841847 · JJO
Reagent Laboratory, Inc.
Toxicology · 121d
Cleared Aug 17, 1984
HOSPITAL'S-SPEC
K842014 · HIB
Merex Co.
Obstetrics & Gynecology · 91d
Cleared Aug 17, 1984
FLU MET 2
K842088 · FPA
Venusa , Ltd.
General Hospital · 85d
Cleared Aug 17, 1984
ACTH STANDARD MATRIX
K842099 · JIT
Diagnostic Systems Laboratories, Inc.
Chemistry · 84d
Cleared Aug 17, 1984
CHOLESTEROL ASSSAY KIT
K842160 · CHH
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 79d
Cleared Aug 17, 1984
AIMED DISPOS. INJECTION NEEDLE
K842230 · GAA
Tech-Cons Ltd., Intl.
General & Plastic Surgery · 73d
Cleared Aug 17, 1984
AIMED SCALP VEIN SET VARIOUS
K842255
Tech-Cons Ltd., Intl.
General & Plastic Surgery · 71d
Cleared Aug 17, 1984
AMER. EDWARDS LAB FLEXISCOPE OBTURATOR
K842323 · HRX
American Edwards Laboratories
Orthopedic · 65d
Cleared Aug 17, 1984
SHILEY VENOUS RESERVOIR
K842337 · DTN
Shiley, Inc.
Cardiovascular · 73d
Cleared Aug 17, 1984
MAXIFILL TRANSFER SET
K842345 · LHI
Lyphomed, Inc.
General Hospital · 64d
Cleared Aug 17, 1984
SPX GENERATOR
K842348 · IZO
General Electric Co.
Radiology · 63d
Cleared Aug 17, 1984
HOWMEDICA KINEMATIC II TIBIAL WEDGE
K842367 · HRY
Howmedica Corp.
Orthopedic · 63d
Cleared Aug 17, 1984
ACA CONJUGATED BILIRUBIN ANALYTICAL
K842385 · CIG
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 60d
Cleared Aug 17, 1984
LUSTER, DENTAL POLISHING PASTE
K842403 · EJR
Scientific Pharmaceuticals, Inc.
Dental · 59d
Cleared Aug 17, 1984
ARGYLE ENTERITE ENTERAL FEEDING PUMP
K842421 · FRN
Sherwood Medical Co.
General Hospital · 58d
Cleared Aug 17, 1984
FSH RIA
K842444 · CGJ
Syncor Intl. Corp.
Chemistry · 57d
Cleared Aug 17, 1984
SKIN SCRUB TRAY STERILE SKIN SCRUB KIT
K842490 · FRG
Biological & Environmental Control...
General Hospital · 52d
Cleared Aug 17, 1984
MATRIS INSTRU. VIDEO IMAGER 1010-
K842494 · IZI
Matrix Instruments
Radiology · 52d
Cleared Aug 17, 1984
MATRIX VIDEO IMAGER 1020 COMPACT CAMER
K842495 · IZI
Matrix Instruments
Radiology · 52d
Cleared Aug 17, 1984
SANDARE ACID PHOSPHATASE PROCEDURE
K842516 · CJR
Sandare Chemical Co., Inc.
Chemistry · 38d
Cleared Aug 17, 1984
BLOOD GAS FLUSH SOL. & FLUSH AGENT 1302
K842519 · CHL
Rna Medical Corp.
Chemistry · 38d
Cleared Aug 17, 1984
CDX80
K842536 · BZG
Cdx Corp.
Anesthesiology · 50d
Cleared Aug 17, 1984
COAT-A-COUNT DHEA-SO4 RIA KIT
K842552 · JKC
Diagnostic Products Corp.
Chemistry · 46d
Cleared Aug 17, 1984
AMES TDA PHENOBARBITAL TEST
K842592 · LET
Miles Laboratories, Inc.
Toxicology · 45d