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

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176,076 results
173737–173760 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 1977
API 20C
K771008 · JXB
Analytical Products, Inc.
Microbiology · 61d
Cleared Aug 03, 1977
IMPREFLEX ALGINATE IMPRESSION MATERIAL
K771120 · LEW
Espe Dental Products
Toxicology · 42d
Cleared Aug 03, 1977
EMPTY ADMIXTURE CONTAINERS
K771121 · KPE
Medi, Inc.
General Hospital · 42d
Cleared Aug 03, 1977
GAMMA GOUNTING SYS., AUTO, MODEL 1400
K771180 · JJJ
G.D. Searle and Co.
Immunology · 34d
Cleared Aug 03, 1977
FETAL/MATERNAL ALRM MODULE - 21595A
K771194 · HGM
Hewlett-Packard Co.
Obstetrics & Gynecology · 33d
Cleared Aug 03, 1977
FETAL/MATERNAL REPEATER - 21596A
K771195 · HGM
Hewlett-Packard Co.
Obstetrics & Gynecology · 33d
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