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
163369–163392 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 08, 1981
NATAL CALF (BOVINE) SERUM - STERILE
K812385 · KIS
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared Sep 08, 1981
FETAL BOVINE SERUM - STERILE
K812386 · KIS
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared Sep 08, 1981
MRI GENTAMICIN RIA KIT
K812394 · DJB
Microanalytic Research, Inc.
Microbiology · 19d
Cleared Sep 01, 1981
REAGENT STRIPS FOR URINALYSIS
K811342 · JRE
Miles Laboratories, Inc.
Chemistry · 112d
Cleared Sep 01, 1981
TANDEM PAP KIT - (PARTS I & II)
K811959 · JFH
Hybritech, Inc.
Chemistry · 54d
Cleared Sep 01, 1981
HERPES VIRUS HOMINIS ANTIBODY TEST SYS.
K812085 · GQL
Zeus Scientific, Inc.
Microbiology · 41d
Cleared Sep 01, 1981
ACRIDINE ORANGE STAIN
K812212 · IDC
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 27d
Cleared Sep 01, 1981
ANTITHROMBIN III SCREEN KIT
K812215 · JBQ
Pacific Hemostasis
Hematology · 27d
Cleared Sep 01, 1981
HELENA HBF QUIPLATE CONTROL
K812226 · KQI
Helena Laboratories
Hematology · 22d
Cleared Sep 01, 1981
GELMAN IG-FIX KIT
K812253 · CZP
Gelman Sciences, Inc.
Chemistry · 21d
Cleared Sep 01, 1981
AURAMINE O MYCROBACTERIAL STAIN SET
K812274 · KJK
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 19d
Cleared Sep 01, 1981
CELESTIN DILATOR
K812289 · KNQ
Inmed Corp.
Gastroenterology & Urology · 19d
Cleared Sep 01, 1981
GLUCOSE-HK SYSTEM PACK TEST
K812303 · CFR
Boehringer Mannheim Corp.
Chemistry · 14d
Cleared Sep 01, 1981
SANDARE URIC ACID PROCEDURE
K812313 · LFQ
Sandare Chemical Co., Inc.
Chemistry · 15d
Cleared Sep 01, 1981
CRITHIDNA ANTI-DNA TEST KIT
K812314 · DHN
Antibodies, Inc.
Immunology · 15d
Cleared Sep 01, 1981
LIPO-SEP CHOLESTEROL AUDIT SYSTEM
K812318
Isolab, Inc.
Chemistry · 15d
Cleared Sep 01, 1981
KAPPA & LAMBDA BENCE JONES CONTROLS
K812327 · CZQ
Kallestad Laboratories, Inc.
Immunology · 14d
Cleared Sep 01, 1981
ZETA-SERA D
K812329 · KIS
Amf Biological and Diagnostics Co.
Microbiology · 14d
Cleared Sep 01, 1981
B-NEOCEPT
K812334 · JHJ
Organon, Inc.
Chemistry · 14d
Cleared Sep 01, 1981
UREA NITROGEN (BUN)
K812341 · CDQ
Pointe Scientific, Inc.,
Chemistry · 14d
Cleared Sep 01, 1981
VENTREX DATA REDUCTION & QUAL. CONTR. SY
K812357 · JPK
Ventrex Laboratories, Inc.
Chemistry · 12d
Cleared Aug 31, 1981
NEOLOOPS
K810890 · DWS
Medical Marketing Systems
Cardiovascular · 151d
Cleared Aug 31, 1981
CARL ZEISS INN MYRINGOTOMY TUBE LINE
K811698 · ETD
James L. Geraci & Associates, Inc.
Ear, Nose, Throat · 76d
Cleared Aug 31, 1981
TRYPIN (125I) RIA KIT
K811805 · JNO
Bd Becton Dickinson Vacutainer...
Chemistry · 68d