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
158977–159000 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 28, 1982
CANDIDA DETECTION SYSTEM
K823016 · LHK
Ramco Laboratories, Inc.
Microbiology · 77d
Cleared Dec 28, 1982
CORDIA CMV
K823123 · LFZ
Cordis Corp.
Chemistry · 67d
Cleared Dec 28, 1982
INTRAOCULAR LENS GUIDE
K823222 · KYB
American Medical Optics
Ophthalmic · 60d
Cleared Dec 28, 1982
NEW FREEDOM THIN UNSCENTED MAXI PADS
K823241 · HHD
Kimberly-Clark Corp.
Obstetrics & Gynecology · 57d
Cleared Dec 28, 1982
FACTOR VIII RELATED ANTIGEN ROCKET EID
K823267 · GGP
Helena Laboratories
Hematology · 56d
Cleared Dec 28, 1982
IMMOPHASE TM HPL RADIOIMMUNOASSAY
K823292 · JMF
Corning Medical & Scientific
Chemistry · 53d
Cleared Dec 28, 1982
HARRIS HEMATOXYLIN
K823328 · HYK
Accra Laboratories, Inc.
Pathology · 50d
Cleared Dec 28, 1982
PAPINCOLABU STAIN EA-36/50/65 & OG-6
K823329 · HZL
Accra Laboratories, Inc.
Pathology · 50d
Cleared Dec 28, 1982
HEMATOLOGY ANALYZER
K823344 · GKL
Abbott Diagnostics
Hematology · 50d
Cleared Dec 28, 1982
H. INFLUENZA B ANTISERA FOR CIE
K823348 · GRP
Diagnostica, Inc.
Immunology · 49d
Cleared Dec 28, 1982
COULTER-COUNTER #S PLUS IV & LYSE S +D
K823355 · GKZ
Coulter Electronics, Inc.
Hematology · 49d
Cleared Dec 28, 1982
DADE ESR KIT
K823368 · JPH
American Dade
Hematology · 48d
Cleared Dec 28, 1982
PEDIATRIC URINE COLLECTOR
K823411 · KNX
Sage Products, Inc.
Gastroenterology & Urology · 43d
Cleared Dec 28, 1982
ALKPHOR SYSTEM
K823445 · CIN
California Immuno Diagnostic, Inc.
Chemistry · 42d
Cleared Dec 28, 1982
FEMALE EXTERNAL URINARY APPLIANCE
K823450 · KNX
Diamed Division Ill. Tool Works, Inc.
Gastroenterology & Urology · 41d
Cleared Dec 28, 1982
SINGLE VIAL AMYLASE PNP TEST
K823462 · JFJ
Boehringer Mannheim Corp.
Chemistry · 39d
Cleared Dec 28, 1982
ULTRA CHEM BAN-UV #65080 & 65081
K823472 · CDQ
Emd Chemicals, Inc.
Chemistry · 36d
Cleared Dec 28, 1982
GAMMADAB LH RADIO-KIT #CA-1508
K823476 · CEP
Clinical Assays, Inc.
Chemistry · 36d
Cleared Dec 28, 1982
ARTHROSCOPIC IRRIGATION SETS-2C4030/31
K823496 · GBX
Travenol Laboratories, S.A.
General & Plastic Surgery · 35d
Cleared Dec 28, 1982
PARA 12
K823498 · GLQ
Streck Laboratories, Inc.
Hematology · 34d
Cleared Dec 28, 1982
TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY
K823507 · DGC
Hybritech, Inc.
Chemistry · 34d
Cleared Dec 28, 1982
CURAY ANTERIOR/POSTERIOR RESTORATIVE
K823510 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 29d
Cleared Dec 28, 1982
FIBROSYSTEM
K823520 · GKQ
Bd Becton Dickinson Vacutainer...
Hematology · 29d
Cleared Dec 28, 1982
DILULAB 230
K823522 · GKH
Innovative Medical Systems, Inc.
Hematology · 29d