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
166513–166536 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 1980
TOXO BIO-BEAD TITRATION KIT
K801720 · GLZ
Litton Bionetics
Microbiology · 55d
Cleared Sep 16, 1980
HSV BIO-BEAD TITRATION KIT
K801721 · GQN
Litton Bionetics
Microbiology · 55d
Cleared Sep 16, 1980
CMV BIO-BEAD TITRATION KIT
K801722 · GQH
Litton Bionetics
Microbiology · 55d
Cleared Sep 16, 1980
FENZL RETICLE
K801733 · HOI
Robert E. Fenzl, M.D.
Ophthalmic · 53d
Cleared Sep 16, 1980
ARIA II 125- I-ESTRIOL SYSTEM
K801735 · CGI
Bd Becton Dickinson Vacutainer...
Chemistry · 53d
Cleared Sep 16, 1980
BECKMAN ASTRA SYSTEMS TOTAL PROTEIN CHEM
K801749 · CEK
Beckman Instruments, Inc.
Chemistry · 50d
Cleared Sep 16, 1980
BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY
K801750 · CIX
Beckman Instruments, Inc.
Chemistry · 50d
Cleared Sep 16, 1980
RAMI ULTRAVIOLET A BOOTH
K801751 · LEJ
Rami-Tan
Radiology · 50d
Cleared Sep 16, 1980
RAMI TAN ULTRAVIOLET B BOOTH
K801752 · LEJ
Rami-Tan
Radiology · 50d
Cleared Sep 16, 1980
GLUCOSE REAGENT(UV-HEXOKINASE)
K801765 · CFR
Reagents Applications, Inc.
Chemistry · 50d
Cleared Sep 16, 1980
DIMENSION I REFRACTION SYSTEM
K801767 · HLM
Smr
Ophthalmic · 50d
Cleared Sep 16, 1980
BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.
K801795 · JGS
J.T. Baker Chemical Co.
Chemistry · 49d
Cleared Sep 16, 1980
WAKO HDL CHOLESTEROL TEST
K801834 · LBS
Wako Pure Chemical Industries, Ltd.
Chemistry · 46d
Cleared Sep 16, 1980
DISPOSABLE HYPODERMIC NEEDLES
K801839 · FMI
Martin'S Maine Exchange
General Hospital · 46d
Cleared Sep 16, 1980
T3(125) RADIOIMMUNOASSAY KIT
K801843 · CDP
Technia Diagnostics , Ltd.
Chemistry · 46d
Cleared Sep 16, 1980
LACTI-QUANT
K801849 · CFT
Nuclear Medical Laboratories, Inc.
Chemistry · 43d
Cleared Sep 16, 1980
CHARLES PNEUMATIC INTRAOCULAR SCISSORS
K801850 · HQE
Cooper Medical Devices Corp.
Ophthalmic · 43d
Cleared Sep 16, 1980
CENTRIFICHEM PIPETTOR 1000
K801851 · JQW
Union Carbide Corp.
Chemistry · 43d
Cleared Sep 16, 1980
SPINAL FLUID CONTROL(HUMAN)
K801854 · JJX
Environmental Chemical Specialties
Chemistry · 43d
Cleared Sep 16, 1980
DATA-ZYME AST(GOT) PROCEDURE
K801856 · CIT
Data Medical Associates, Inc.
Chemistry · 43d
Cleared Sep 16, 1980
DATA-ZYME LAT(GPT) PROCEDURE
K801857 · CKA
Data Medical Associates, Inc.
Chemistry · 43d
Cleared Sep 16, 1980
PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A
K801866 · EQL
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 42d
Cleared Sep 16, 1980
STREP B POLYVALENT FLUORO-KIT
K801876 · GTX
Clinical Sciences, Inc.
Microbiology · 42d
Cleared Sep 16, 1980
SLIT LAMP ATTACHMENT
K801877 · HQB
Cavitron Corp.
Ophthalmic · 41d