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
162961–162984 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 1981
ANAEROBIC BLOOD AGAR
K812795 · JSG
Isle Media and Sterile Products, Inc.
Microbiology · 14d
Cleared Oct 20, 1981
ANAEROBIC CNA BLOOD AGAR
K812796 · JSJ
Isle Media and Sterile Products, Inc.
Microbiology · 14d
Cleared Oct 20, 1981
SCHAEDLER AGARS
K812797 · JSG
Isle Media and Sterile Products, Inc.
Microbiology · 14d
Cleared Oct 20, 1981
MOTILITY GI MEDIUM
K812798 · JSG
Isle Media and Sterile Products, Inc.
Microbiology · 14d
Cleared Oct 20, 1981
DCATS
K812799 · IYM
Dorex, Inc.
Radiology · 14d
Cleared Oct 20, 1981
FLOW-DIRECTED THERMODILUTION CATHETER
K812800 · KRB
Sorensen Research
Cardiovascular · 14d
Cleared Oct 20, 1981
HIP STEM SYSTEM TITANIUM ALLOY
K812801 · JDI
Osteonics Corp.
Orthopedic · 14d
Cleared Oct 19, 1981
PHOTOGRAPHIC EQUIPMENT
K812201 · FEM
Reznik Instruments
Radiology · 76d
Cleared Oct 19, 1981
PLASTILIX MINIRAD D CASSETTE
K812535 · IXA
Eastman Kodak Company
Radiology · 46d
Cleared Oct 19, 1981
POLAROID INSTANT ENDOCAMERA
K812542 · FEM
Polaroid Corp.
Radiology · 45d
Cleared Oct 19, 1981
MODEL H12-10
K812575 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 40d
Cleared Oct 19, 1981
UNSCENTED MENSTRUAL PADS
K812577 · HHD
Weyerhaeuser Co.
Obstetrics & Gynecology · 40d
Cleared Oct 19, 1981
SCANNER 700
K812588 · IYO
National Ultrasound Corp.
Radiology · 38d
Cleared Oct 19, 1981
FERRITIN KIT
K812597 · DBF
Hybritech, Inc.
Immunology · 35d
Cleared Oct 19, 1981
ADJUSTABLE MICROSURGICAL KNIFE
K812620 · HNN
Vxtra Corp.
Ophthalmic · 34d
Cleared Oct 19, 1981
BECKMAN ICS CALIBRATOR
K812649 · JIX
Beckman Instruments, Inc.
Chemistry · 32d
Cleared Oct 19, 1981
BECKMAN ICS NORMAL CONTROL SERA
K812650 · JJY
Beckman Instruments, Inc.
Chemistry · 32d
Cleared Oct 19, 1981
NEUROMED SELECTRA #7720
K812704 · GZJ
Medtronic Vascular
Neurology · 26d
Cleared Oct 19, 1981
NON-STERILE SHADOW-STRIPE CATHETER
K812717 · FKO
Quinton, Inc.
Gastroenterology & Urology · 24d
Cleared Oct 19, 1981
CUFF MATERIAL ON PEDIATRIC SIZE CATH.
K812718 · FJS
Quinton, Inc.
Gastroenterology & Urology · 24d
Cleared Oct 19, 1981
SEPTI-CHEK BLOOD CULTURE BOTTLE ROCHE
K812729 · JSG
Hoffmann-La Roche, Inc.
Microbiology · 21d
Cleared Oct 19, 1981
SEPTI-CHECK BLOOD CULTURE SLIDE
K812731 · JSI
Hoffmann-La Roche, Inc.
Microbiology · 21d
Cleared Oct 19, 1981
SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE
K812732 · JSG
Hoffmann-La Roche, Inc.
Microbiology · 21d
Cleared Oct 19, 1981
MACHIDA FLEXIBLE INTUBATION SCOPE FLS-P
K812734 · EQN
Machida America, Inc.
Ear, Nose, Throat · 20d