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

Filters: Cleared only ×
176,076 results
63649–63672 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 08, 2006
KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM
K060079 · MUH
Eastman Kodak Company
Radiology · 29d
Cleared Feb 08, 2006
DIAGNODENT 2190 WITH PERIODONTAL PROBE
K060080 · NTK
Kavo Dental Corporation
Dental · 29d
Cleared Feb 08, 2006
BIO-RAY SDX DIGITAL X-RAY SYSTEM
K060179 · MUH
Sigma Biomedics, Inc.
Radiology · 16d
Cleared Feb 07, 2006
AESKULISA GLIA A AND AESKULISA GLIA G
K052439 · MST
Aesku Diagnostics
Immunology · 154d
Cleared Feb 07, 2006
IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS...
K052793 · MST
Pharmacia Diagnostics AB
Immunology · 127d
Cleared Feb 07, 2006
XLTEK NEUROPATH, MODEL PK1070
K053058 · JXE
Excel Tech. , Ltd.
Neurology · 99d
Cleared Feb 07, 2006
ROCHE ELECSYS ANTI-TG
K053426 · JZO
Roche Diagnostics Corp.
Immunology · 61d
Cleared Feb 07, 2006
DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR
K053576 · JIT
Dade Behring, Inc.
Chemistry · 47d
Cleared Feb 07, 2006
TRIMED BONE PLATES
K060041 · HRS
TriMed, Inc.
Orthopedic · 32d
Cleared Feb 07, 2006
KODAK PACS
K060055 · LLZ
Eastman Kodak Company
Radiology · 29d
Cleared Feb 07, 2006
LYSUS INFUSION SYSTEM
K060084 · QEY
Ekos Corp.
Cardiovascular · 27d
Cleared Feb 07, 2006
VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS
K060142 · DSY
Vascutek, Ltd.
Cardiovascular · 19d
Cleared Feb 07, 2006
EL-ACL SCREEN
K060176 · MID
Theratest Laboratories, Inc.
Immunology · 15d
Cleared Feb 06, 2006
SEJOY, MODEL MT-403
K051699 · FLL
Sejoy Electronics & Instruments Co.,...
General Hospital · 227d
Cleared Feb 06, 2006
SHEFFIELD BRAND WARMING LUBRIGEL PERSONAL LUBRICANT
K052162 · NUC
Sheffield Laboratories, Div. of Faria...
Obstetrics & Gynecology · 181d
Cleared Feb 06, 2006
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
K053061 · MKW
Dade Behring, Inc.
Toxicology · 98d
Cleared Feb 06, 2006
ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065,...
K053094 · HSH
Advanced Bio-Surfaces, Inc.
Orthopedic · 95d
Cleared Feb 06, 2006
MODIFICATION TO: MINIMESH POLYPROPYLENE MESH
K053361 · OTO
Mpathy Medical Devices, Ltd.
Obstetrics & Gynecology · 66d
Cleared Feb 06, 2006
COLUMBUS (CR) TOTAL KNEE SYSTEM
K053390 · JWH
Aesculap, Inc.
Orthopedic · 63d
Cleared Feb 06, 2006
MODIFICATION TO: V.A.C. GRANUFOAM SILVER PROTECTION DRESSING
K053627 · OMP
Kci USA, Inc.
General & Plastic Surgery · 39d
Cleared Feb 06, 2006
MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS
K060107 · LZO
Exactech, Inc.
Orthopedic · 24d
Cleared Feb 03, 2006
MDL SERIES DIODE LASERS, MODEL MDL-10/15
K042114 · GEX
Vision Lasertechnik, GmbH
General & Plastic Surgery · 547d
Cleared Feb 03, 2006
SUCRALFATE AND CARAFATE PASTE KITS
K043587 · FRO
Patrick D. Mcgrath Ph.D
General & Plastic Surgery · 402d
Cleared Feb 03, 2006
T-SLING
K050516 · OTN
Herniamesh S.R.L.
Gastroenterology & Urology · 339d