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
151921–151944 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 1984
MPL HYPO BRAND BREECH LOAD ASPIR SYRINGE
K843314 · EJI
Smith & Nephew, Mpl Division
Dental · 34d
Cleared Sep 27, 1984
GONO-PAK W/THAYER-MARTIN AGAR/GONO-PAK
K843341 · JTW
Bd Becton Dickinson Vacutainer...
Microbiology · 31d
Cleared Sep 27, 1984
URINE TRANSPORT KIT
K843359 · JTW
Applied Polytechnology, Inc.
Microbiology · 31d
Cleared Sep 27, 1984
ISO-DATA IMMUNOASSAY NETWORK SYSTEM
K843365 · JQP
Iso-Data, Inc.
Chemistry · 30d
Cleared Sep 27, 1984
EOSIN Y 1% ALCOHOLIC
K843426 · HYB
Accra Laboratories, Inc.
Pathology · 23d
Cleared Sep 27, 1984
BIOFIX
K843428 · LDZ
Accra Laboratories, Inc.
Pathology · 23d
Cleared Sep 27, 1984
DENTAL CHAIR
K843436 · KLC
Swedish Dental Products, Inc.
Dental · 23d
Cleared Sep 27, 1984
STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ
K843452 · JGS
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Sep 27, 1984
EMIT 700 PHENCYCLIDINE ASSAY
K843509 · LCM
Syva Co.
Toxicology · 21d
Cleared Sep 27, 1984
PROGRAMMABLE STIMULATOR 5326
K843718 · JOQ
Medtronic Vascular
Cardiovascular · 3d
Cleared Sep 26, 1984
THEOPHYLLINE KIT FLUORESCENCE POLARIZA-
K842585 · LER
Windsor Laboratories, Inc.
Toxicology · 85d
Cleared Sep 26, 1984
PHENYTOIN KIT FLUORESCENCE POLARIZATION
K842586 · LGR
Windsor Laboratories, Inc.
Immunology · 85d
Cleared Sep 26, 1984
C-SECTION TRAY
K842627 · KDD
Deroyal Industries, Inc.
General & Plastic Surgery · 82d
Cleared Sep 26, 1984
EMIT D.A.U. AMPHETAMINE ASSAY
K842674 · DKZ
Syva Co.
Toxicology · 78d
Cleared Sep 26, 1984
EMIT D.A.U. BARBITURATE ASSAY
K842675 · DIS
Syva Co.
Toxicology · 78d
Cleared Sep 26, 1984
EMIT D.A.U. METHADONE ASSAY
K842676 · DJR
Syva Co.
Toxicology · 78d
Cleared Sep 26, 1984
EMIT D.A.U. OPIATE ASSAY
K842677 · DJG
Syva Co.
Toxicology · 78d
Cleared Sep 26, 1984
SURGITEK RECONSTRUC-NIPPLE PROSTHESIS
K842748
Medical Engineering Corp.
General & Plastic Surgery · 75d
Cleared Sep 26, 1984
EMIT D.A.U. BENZODIAZEPINE ASSAY
K842815 · JXM
Syva Co.
Toxicology · 70d
Cleared Sep 26, 1984
ELECTRONIC EPILATOR TS-1
K843063 · KCW
R. A. Fischer Co. Corp.
General & Plastic Surgery · 51d
Cleared Sep 26, 1984
BRIMFIELD CANNULATED MAGNETIC RETRIEVER
K843135 · FCC
Brimfield Scientific Instruments
Gastroenterology & Urology · 48d
Cleared Sep 26, 1984
STRATUS LIDOCAINE FLUOROMETRIC ENZYME
K843184 · KLR
American Dade
Immunology · 44d
Cleared Sep 26, 1984
TRICON-P TIBIAL COMPONENT
K843241 · JWH
Richards Medical Co., Inc.
Orthopedic · 50d
Cleared Sep 26, 1984
TRICON M TIBIAL COMPONENT
K843242 · JWH
Richards Medical Co., Inc.
Orthopedic · 50d