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
172897–172920 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 1977
MARKER GENERATOR MODULES - 21597A
K771196 · HGM
Hewlett-Packard Co.
Obstetrics & Gynecology · 33d
Cleared Aug 03, 1977
AP ISOTROL, #A 0140
K771225 · CIN
Sigma Chemical Co.
Chemistry · 29d
Cleared Aug 03, 1977
HTSH RIA HUMAN THYROID HORMONE RIA
K771235 · JLW
Abbott Laboratories
Chemistry · 23d
Cleared Aug 03, 1977
TRIOBEAD-125 DIAGNOSTIC KIT
K771236 · CEC
Abbott Laboratories
Immunology · 23d
Cleared Aug 03, 1977
ANTISERA TO HUMAN FAB FRAGMENT
K771242 · DDR
Kent Laboratories, Inc.
Microbiology · 23d
Cleared Aug 03, 1977
ANTISERA TO HUMAN FAB FRAGMENT
K771243 · DFK
Kent Laboratories, Inc.
Microbiology · 23d
Cleared Aug 03, 1977
LINEAR ACCELERATOR G-2900
K771260 · IYE
Atomic Energy of Canada
Radiology · 21d
Cleared Aug 03, 1977
RADIOMHTER OSM-2 HEMOXIMETER
K771263 · GHS
The London Co.
Hematology · 23d
Cleared Aug 03, 1977
CONTACT COMPOUNT SONOLAY. SAC-10A
K771290 · IYO
Toshiba Medical Systems
Radiology · 55d
Cleared Aug 03, 1977
X-RAY DIAG. TABLE DT-KCS
K771293 · IXR
Toshiba Medical Systems
Radiology · 55d
Cleared Aug 03, 1977
X-RAY GENERATOR MODEL KXO-15
K771294 · IZO
Toshiba Medical Systems
Radiology · 55d
Cleared Aug 03, 1977
X-RAY GENERATOR MODEL KX0-825
K771295 · IZO
Toshiba Medical Systems
Radiology · 55d
Cleared Aug 03, 1977
TUBE CONVEYOR MODEL DS-PB-4
K771296 · IZF
Toshiba Medical Systems
Radiology · 55d
Cleared Aug 03, 1977
TUBESTAND MODEL DS-TA-4
K771297 · IZF
Toshiba Medical Systems
Radiology · 55d
Cleared Aug 03, 1977
6 L.L. SYSTEM
K771298 · JAA
Toshiba Medical Systems
Radiology · 55d
Cleared Aug 03, 1977
RIA FOR TOTAL THYROXINE
K771309 · CDX
Abbott Laboratories
Chemistry · 16d
Cleared Aug 03, 1977
CALCIUM REAGENT
K771310 · CIC
Mallinckrodt Critical Care
Chemistry · 16d
Cleared Aug 03, 1977
GLUCOSE REAGENT (HEXOHINASE)
K771311 · CFR
Mallinckrodt Critical Care
Chemistry · 16d
Cleared Aug 03, 1977
BLOOD UREA NITROGEN (BUN) REAGENT
K771312 · CDW
Mallinckrodt Critical Care
Chemistry · 16d
Cleared Aug 03, 1977
CHOLESTEROL REAGENT
K771313 · CGO
Mallinckrodt Critical Care
Chemistry · 16d
Cleared Aug 03, 1977
GLUCOSE REAGENT (O-TOLUIDINE)
K771314 · CGE
Mallinckrodt Critical Care
Chemistry · 16d
Cleared Aug 03, 1977
HYDRON BURN BANDAGE
K771321 · KMF
Abbott Laboratories
General & Plastic Surgery · 16d
Cleared Aug 03, 1977
UVIOBOND
K771328 · KLE
Espe GmbH (Us)
Dental · 16d
Cleared Aug 03, 1977
CREATININE ANALYZER 2
K771335 · CGX
Beckman Instruments, Inc.
Chemistry · 16d