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
158473–158496 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 18, 1983
DIGITAL BEDSIDE SCALE #5000
K830171 · FRW
Acme Medical Scale Co.
General Hospital · 31d
Cleared Feb 18, 1983
STERILE COTTON ROLLS #3, 1 1/2
K830175 · EFN
Veratex Corp.
Dental · 31d
Cleared Feb 18, 1983
BIOCELL SPINAL FLUID CONTROL
K830179 · JJY
Biocell Laboratories, Inc.
Immunology · 31d
Cleared Feb 18, 1983
NEURO DIAGNOSTICS MODEL FCR
K830191 · GWK
Neurodiagnostics, Inc.
Neurology · 29d
Cleared Feb 18, 1983
NO BOIL DUAL COUNT VIT-B12 & FOLIC ACID
K830195 · CDD
Diagnostic Products Corp.
Chemistry · 29d
Cleared Feb 18, 1983
DAC-CEL DIAGNATAL RD 50
K830203 · JHI
Wellcome Diagnostics
Chemistry · 29d
Cleared Feb 18, 1983
DAC-CEL DIAGNATAL HCG STANDARDS RD49
K830204 · JJX
Wellcome Diagnostics
Chemistry · 29d
Cleared Feb 18, 1983
TDX N-ACETYLPROCAINAMIDE
K830206 · LAN
Abbott Laboratories
Chemistry · 28d
Cleared Feb 18, 1983
REAGENTS CORNING CHLORIDE METER FOR
K830217 · JFS
Fisher Scientific Co., LLC
Chemistry · 25d
Cleared Feb 18, 1983
THE TOOTHPIK
K830225 · JES
Fred M. Davis
Dental · 25d
Cleared Feb 18, 1983
CONTOX HEAVYMETALS CONTROL
K830234 · DIF
Kaulson Laboratories, Inc.
Toxicology · 24d
Cleared Feb 18, 1983
TRANSLUCENT POLY. CATH. CONNECTOR AND
K830237 · DQO
Vertex Medical Corp.
Cardiovascular · 24d
Cleared Feb 18, 1983
ULTRA CHEM CRESOLCAVERSACHEM #65082
K830238 · CIC
Emd Chemicals, Inc.
Chemistry · 24d
Cleared Feb 18, 1983
ULTRAZYME PLUS GAMMA GT-MCA #65055-65056
K830240 · JQB
Emd Chemicals, Inc.
Chemistry · 24d
Cleared Feb 18, 1983
CAST SHOE, CAST BOOT
K830246 · JQB
Warm & Form, Orthopedic Materials
Chemistry · 24d
Cleared Feb 17, 1983
EXPANDED PTFE PROSTHESIS BLOOD ACCES
K823748
C.R. Bard, Inc.
Gastroenterology & Urology · 66d
Cleared Feb 17, 1983
DE VO/44 OXYGEN CONCENTRATOR #444
K830174 · CAW
The Devilbiss Co.
Anesthesiology · 30d
Cleared Feb 16, 1983
KF-101-07 DIALYZER
K822337 · KOC
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 196d
Cleared Feb 16, 1983
KF-101-10 DIALYZER
K822338 · KOC
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 196d
Cleared Feb 16, 1983
KF-101-13 DIALYZER
K822339 · KOC
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 196d
Cleared Feb 16, 1983
DIRECT FA CONJUGATE FOR LEGIONELLA SPP
K822859 · LHL
Zeus Technologies
Microbiology · 142d
Cleared Feb 16, 1983
MICROELISA MINIREADER II
K830200 · LBI
Dynatech Corp.
Chemistry · 27d
Cleared Feb 15, 1983
CETUS CMV IHA
K822965 · LJO
Cetus Corp.
Immunology · 131d
Cleared Feb 15, 1983
BIOSELF 101
K823209 · LHD
Bioself, Inc.
Obstetrics & Gynecology · 110d