FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
155401–155424 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 1983
I.V. FILTER HOLDER
K832300 · KMK
Saxnor Corp.
General Hospital · 83d
Cleared Oct 04, 1983
ARTHROSCOPY FLUID MGMT. SYSTEM
K832315 · HRX
3M Health Care, Sarns
Orthopedic · 82d
Cleared Oct 04, 1983
ARTHROSCOPE-VARIOUS MODELS FIBEROPTIC
K832341 · HRX
Kamiya Tsusan Kaisha, Ltd.
Orthopedic · 84d
Cleared Oct 04, 1983
VIBRATORY ENDODONTIC SYSTEM
K832378 · EKQ
Syntex Dental Products, Inc.
Dental · 77d
Cleared Oct 04, 1983
SIAS IRRIGATION/ASPIRATION SYSTEM
K832413 · HQC
Clark Pool & Assoc.
Ophthalmic · 75d
Cleared Oct 04, 1983
GREAT LAKES PASTE SOLDER
K832425 · EJS
Great Lakes Orthodontics, Ltd.
Dental · 74d
Cleared Oct 04, 1983
BROOK LIFE SAVING AIRWAY DEVICE #900 &
K832435 · CAE
La Societe Fianciere Senefin
Anesthesiology · 71d
Cleared Oct 04, 1983
CAVITY CLEANSER
K832497 · LBH
Den-Mat Corp.
Dental · 69d
Cleared Oct 04, 1983
TRYPTOSE SULFITE CYCLOSERINE AGAR PLATE
K832523 · JSI
Otisville Biotech, Inc.
Microbiology · 67d
Cleared Oct 04, 1983
BAIRD PARKER AGAR PLATE
K832524 · JSI
Otisville Biotech, Inc.
Microbiology · 67d
Cleared Oct 04, 1983
IRRIGATION/ASPIRATION PACK
K832525
Intermedics Intraocular, Inc.
General & Plastic Surgery · 67d
Cleared Oct 04, 1983
SELENITE CYSTINE BROTH
K832533 · KZI
Otisville Biotech, Inc.
Microbiology · 67d
Cleared Oct 04, 1983
SHEEP BLOOD AGAR PLATE
K832534 · JSG
Otisville Biotech, Inc.
Microbiology · 67d
Cleared Oct 04, 1983
HEKTOEN ENTERIC AGAR PLATE
K832535 · JSI
Otisville Biotech, Inc.
Microbiology · 67d
Cleared Oct 04, 1983
BRILLIANT GREEN AGAR PLATE
K832536 · JSJ
Otisville Biotech, Inc.
Microbiology · 67d
Cleared Oct 04, 1983
RIME COLI KIT
K832587 · JTO
Austin Biological Laboratories
Microbiology · 63d
Cleared Oct 04, 1983
HI-LO TEMP TYMPANIC TEMP. SENSOR
K832635 · FLL
Mallinckrodt Critical Care
General Hospital · 61d
Cleared Oct 04, 1983
QUICK-TELL INDIRECT PREGNANCY TEST
K832640 · JHJ
Stanbio Laboratory
Chemistry · 61d
Cleared Oct 04, 1983
WINDSOR MEDICAL MODEL 52
K832641 · FRN
Windsor Medical, Inc.
General Hospital · 61d
Cleared Oct 04, 1983
ATI FOREHEAD THERMOMETER
K832651 · KPD
American Thermal Instruments, Inc.
General Hospital · 57d
Cleared Oct 04, 1983
DIRECTOR
K832658 · FMF
Pharmacia, Inc.
General Hospital · 57d
Cleared Oct 04, 1983
DENTAL SYRINGE SYSTEM-VARIOUS STYLES
K832662 · KXR
Centrix, Inc.
Dental · 57d
Cleared Oct 04, 1983
SERALYZER TRIGLYCERIDES REAGENT STRIPS
K832684 · CDT
Miles Laboratories, Inc.
Chemistry · 56d
Cleared Oct 04, 1983
LYPHOCHEK SERUM REF. STANDARD-BOVINE
K832695 · JIX
Bio-Rad
Chemistry · 55d