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
171073–171096 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 1978
IRON 59 KIT
K781769 · JJA
Ria Products, Inc.
Chemistry · 49d
Cleared Dec 04, 1978
BLOOD SUGAR
K781783 · LFR
Gilford Diagnostics
Chemistry · 46d
Cleared Dec 04, 1978
OVU-GUIDE
K781817 · FLK
Reproduction Research Laboratories
General Hospital · 35d
Cleared Dec 04, 1978
COMPUTER, 3500, GILFORD SYSTEM
K781828 · KLI
Syva Co.
Chemistry · 35d
Cleared Dec 04, 1978
TELEMETRY SYSTEM, BIOTEL 300
K781836 · DRG
Spacelabs, Inc.
Cardiovascular · 35d
Cleared Dec 04, 1978
ELECTRODES, IMPLANTABLE WITH ADAPTER
K781849 · DTB
Telectronics, Inc.
Cardiovascular · 38d
Cleared Dec 04, 1978
CHOLESTEROL STANDARDS
K781853 · JIS
Bd Becton Dickinson Vacutainer...
Chemistry · 28d
Cleared Dec 04, 1978
PAD, B-D I.V. CATH.
K781854 · KGZ
Bd Becton Dickinson Vacutainer...
General & Plastic Surgery · 28d
Cleared Dec 04, 1978
REAGENT SYSTEM, NO 46-OV FOR CPK
K781859 · CGS
Sigma Chemical Co.
Chemistry · 28d
Cleared Dec 04, 1978
ASSAY, CHROMOGENIC ANTITHROMBIN III
K781860 · JBQ
Ortho Diagnostics, Inc.
Chemistry · 28d
Cleared Dec 04, 1978
IRON BINDING CAPICITY MODEL 0370
K781865 · JIY
Stanbio Laboratory
Chemistry · 28d
Cleared Dec 04, 1978
ASSAY KIT, THROMBO-SCREEN
K781880 · GIS
Pacific Hemostasis
Hematology · 28d
Cleared Dec 04, 1978
DILUTER, LSA 290 PIPETTER
K781883 · JQW
Kallestad Laboratories, Inc.
Chemistry · 27d
Cleared Dec 04, 1978
CHAMBER, MC-1 DISPOSABLE PRESSURE
K781890 · DXS
Delta Medical Industries
Cardiovascular · 28d
Cleared Dec 04, 1978
LOCATOR, FOREIGN BODY
K781892 · HPM
Keeler Optical Products , Ltd.
Ophthalmic · 26d
Cleared Dec 04, 1978
INSUFFALATOR LAPARAOSCOPIC
K781913 · HIF
Kli
Obstetrics & Gynecology · 20d
Cleared Dec 04, 1978
MUCUS ASPIRATOR
K781917 · FMF
Ovutime, Inc.
General Hospital · 21d
Cleared Dec 04, 1978
PLAQUE DETECTION SYSTEM
K781919 · NYH
Clairol, Inc.
Dental · 21d
Cleared Dec 04, 1978
VALVE, VENT-AWAY TWO-WAY
K781920 · CBP
Chesebrough-Pond'S U.S.A. Co.
Anesthesiology · 21d
Cleared Dec 04, 1978
DISPENSOR, XENON GAS
K781933 · IYT
Diagnostic Isotapes, Inc.
Radiology · 14d
Cleared Dec 04, 1978
PROCESSOR, MODEL M8
K781934 · IXW
Eastman Kodak Company
Radiology · 14d
Cleared Dec 04, 1978
SCANNER-EMI 7020 AND 7020R
K781936 · JAK
Emi Medical, Inc.
Radiology · 14d
Cleared Dec 04, 1978
MINIWASH
K781942 · JTC
Dynatech Laboratories, Inc.
Chemistry · 17d
Cleared Dec 04, 1978
TENDON ROD MODEL OR41PO3-6
K781943 · HXA
Holter-Hausner Intl.
Orthopedic · 17d