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
150625–150648 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 07, 1985
PHENOL RED BROTH W/CARBOHYDRATES
K844539 · JSF
bioMerieux, Inc.
Microbiology · 47d
Cleared Jan 07, 1985
CYSTINE TRYPTIC AGAR W/FRUCTOSE
K844540 · JSF
bioMerieux, Inc.
Microbiology · 47d
Cleared Jan 07, 1985
TRYPTIC SOY BROTH
K844541 · JSG
bioMerieux, Inc.
Microbiology · 47d
Cleared Jan 07, 1985
BEHIND THE EAR HEARING AID BERNAFON T-88P
K844621 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 41d
Cleared Jan 07, 1985
MODEL 363C HEARING AID
K844648 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 39d
Cleared Jan 07, 1985
PERIDOCHROM CHOLESTEROL HIGH PERFORMANCE
K844655 · CHH
Boehringer Mannheim Corp.
Chemistry · 39d
Cleared Jan 07, 1985
EUROCHIMA SERUM PROTEIN ELECTROPHORESIS METHOD
K844710 · JJN
Logos Scientific, Inc.
Chemistry · 35d
Cleared Jan 07, 1985
K-TUBE
K844745 · KNT
Midwest Metabolic Support Group
Gastroenterology & Urology · 32d
Cleared Jan 07, 1985
EPPENDORF DILUTER
K844798 · JQW
Medical Technomics, Ltd.
Chemistry · 27d
Cleared Jan 05, 1985
YERSINIA SELECTIVE AGAR
K844535 · JSI
bioMerieux, Inc.
Microbiology · 45d
Cleared Jan 04, 1985
TYMPANOSTOMY TUBES-VARIOUS
K833246 · ETD
Abco Dealers, Inc.
Ear, Nose, Throat · 484d
Cleared Jan 04, 1985
CORDIA T-M
K843417 · LGD
Cordis Corp.
Immunology · 126d
Cleared Jan 04, 1985
ACCESS HEMAWIPE
K843601 · KHE
Medtech Products, Inc.
Hematology · 114d
Cleared Jan 04, 1985
DIRECTIGEN GROUP A STREP TEST KIT
K843713 · GTZ
Bd Becton Dickinson Vacutainer...
Microbiology · 105d
Cleared Jan 04, 1985
LEUKOSTIX REAGENT STRIPS FOR URINALYSIS
K843727 · LJX
Miles Laboratories, Inc.
Chemistry · 102d
Cleared Jan 04, 1985
LATEX-R RICKETTSII
K843794 · GPP
Health Research, Inc.
Microbiology · 99d
Cleared Jan 04, 1985
CLEANSE N BOND I
K844133 · DYH
Lee Pharmaceuticals
Dental · 73d
Cleared Jan 04, 1985
CLEANSE N BOND II
K844134 · DYH
Lee Pharmaceuticals
Dental · 73d
Cleared Jan 04, 1985
ACTIVE VERTICAL CORRECTOR APPLIANCE
K844234 · ECO
Active Vertical Correctors, Inc.
Dental · 64d
Cleared Jan 04, 1985
BBL PORT-A-CUL 21628 DOUBLE SWAB SULTURE COLLECTIO
K844369 · JSM
Precision Dynamics Corp.
Microbiology · 52d
Cleared Jan 04, 1985
BBL PORT-A-CUL 21627 SINGLE SWAB CULTURE COLLECT
K844370 · JSM
Precision Dynamics Corp.
Microbiology · 52d
Cleared Jan 04, 1985
BILE DIFFERENTIAL DISK
K844380 · JTO
Anaerobe Systems
Microbiology · 52d
Cleared Jan 04, 1985
COLISTIN 10 MCG. DIFFERENTIAL DISK
K844381 · JTO
Anaerobe Systems
Microbiology · 52d
Cleared Jan 04, 1985
VANCOMYCIN 5MCG DIFFERENTIAL DISK
K844382 · JTO
Anaerobe Systems
Microbiology · 52d