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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
150457–150480 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 18, 1985
UNITED SKIN BARRIERS
K844938 · EXB
Pfizer, Inc.
Gastroenterology & Urology · 29d
Cleared Jan 18, 1985
EMIT IMIPRAMINE/DESIPRAMINE CONTROL
K844945 · DIF
Syva Co.
Toxicology · 29d
Cleared Jan 18, 1985
EMIT AMITRIPTYLINE/NORTRIPTYLINE CONTROL
K844946 · DIF
Syva Co.
Toxicology · 29d
Cleared Jan 18, 1985
EMIT QST ACETAMINOPHEN ASSAY
K844962 · LDP
Syva Co.
Toxicology · 25d
Cleared Jan 18, 1985
VAS-CATH CONTINOUS EPIDURAL ANESTH. CATH/KIT/TRAY
K844982 · CAZ
Vas-Cath of Canada , Ltd.
Anesthesiology · 23d
Cleared Jan 18, 1985
ROCHE REAGENTS REAGENT FOR URIC ACID
K844986 · CDO
Roche Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Jan 18, 1985
ROCHE REAGENTS REAGENT FOR CO2
K844987 · KHS
Roche Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Jan 18, 1985
GLUCOSE(HEXOKINASE) REAGENT SET
K844998 · CFR
Sterling Biochemical, Inc.
Chemistry · 23d
Cleared Jan 18, 1985
BAKER CKMB REAGENT SET
K845024 · JHY
Hybritech, Inc.
Chemistry · 22d
Cleared Jan 18, 1985
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
K845027 · CHI
Eastman Kodak Company
Chemistry · 22d
Cleared Jan 18, 1985
DU PONT TOBRAMYCIN ASSAY CALIBRATOR
K850057 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 10d
Cleared Jan 18, 1985
DU PONT TOBRAMYCIN ASSAY REAGENTS
K850058 · LCR
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 10d
Cleared Jan 18, 1985
DU PONT GENTAMICIN ASSAY CALIBRATOR
K850059 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 10d
Cleared Jan 18, 1985
DU PONT GENTAMICIN ASSAY REAGENTS
K850060 · LCD
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 10d
Cleared Jan 17, 1985
CONTOUR CHAIR LOUNGE W/OPTIIONAL HEAT & MASSAGE
K844025 · INO
Craftmatic/Contour Organization, Inc.
Physical Medicine · 94d
Cleared Jan 16, 1985
RESPIRATORY GAS HUMIDIFIER
K842597 · BZE
Applinc
Anesthesiology · 197d
Cleared Jan 16, 1985
BP 5000
K843137 · DXN
Tech Vend Marketing
Chemistry · 160d
Cleared Jan 16, 1985
LP4 VENTILATOR
K844081 · CBK
Life Products, Inc.
Anesthesiology · 89d
Cleared Jan 16, 1985
STANDARD URINARY DRAINAGE BAG & LEG BAG
K844155 · KNX
Norris W. Whitlock
Gastroenterology & Urology · 84d
Cleared Jan 16, 1985
ND:YAG LASER UROLOGICAL SURGERY
K844459 · LNK
Endo Lase, Inc.
Gastroenterology & Urology · 62d
Cleared Jan 16, 1985
ND. YAG LASER RECTAL PATHOLOGY
K844460 · LNK
Endo Lase, Inc.
Gastroenterology & Urology · 62d
Cleared Jan 16, 1985
CYSTINE TRYPTIC AGAR W/DEXTROSE
K844542 · JSF
bioMerieux, Inc.
Microbiology · 56d
Cleared Jan 16, 1985
CYSTINE TRYPTIC AGAR W/LACTOSE
K844543 · JSF
bioMerieux, Inc.
Microbiology · 56d
Cleared Jan 16, 1985
CYSTINE TRYPTIC AGAR W/MALTOSE
K844544 · JSF
bioMerieux, Inc.
Microbiology · 56d