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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
146929–146952 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 1985
BIO-TEK EL 401 HANDHELD MICROPLATE WASHER
K853920 · JTC
Bio-Tek Instruments, Inc.
Microbiology · 29d
Cleared Oct 22, 1985
BETA-TSH-IRMA
K853977 · JLW
Leeco Diagnostics, Inc.
Chemistry · 26d
Cleared Oct 22, 1985
ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT)
K854017 · KHW
Lmd Laboratories
Microbiology · 22d
Cleared Oct 22, 1985
XYLENE SUBSTITUTE MONTANT
K854083 · KEM
Lerner Laboratories, Inc.
Pathology · 15d
Cleared Oct 21, 1985
SENSOR TAPE CAT. NO. ST-45
K852407 · DTW
American Omni Medical, Inc.
Cardiovascular · 137d
Cleared Oct 21, 1985
HA-1000 & HA-500 HYDROXYLAPATITE TOOTH ROOT SUBSTI
K852766 · LYC
Orthomatrix, Inc.
Dental · 115d
Cleared Oct 21, 1985
CERAMIC ALLOY NO. DW 179
K852895 · EJH
Williams Gold Refining Co., Inc.
Dental · 104d
Cleared Oct 21, 1985
QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT
K852999 · DEH
Kallestad Laboratories, Inc.
Immunology · 98d
Cleared Oct 21, 1985
ADVANCED CARDIOVASCULAR SYSTEMS DOUBLE LUMEN BALLO
K853746 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 42d
Cleared Oct 21, 1985
SUN KING
K853752 · FTC
American Chase Company, Inc.
General & Plastic Surgery · 42d
Cleared Oct 21, 1985
UV-A SUNTANNING EQUIPMENT
K853911 · FTC
Eurotan Intl.
General & Plastic Surgery · 31d
Cleared Oct 18, 1985
MODEL TT25RF
K844178 · GEX
Inframed, Inc.
General & Plastic Surgery · 357d
Cleared Oct 18, 1985
DR. BRUNO LNAGE MINI PHOTOMETER
K851575
Texas Medical Products, Inc.
Chemistry · 184d
Cleared Oct 18, 1985
QCT-BONE MINERAL PHANTOM
K852509 · KGI
Image Analysis, Inc.
Radiology · 128d
Cleared Oct 18, 1985
COMPUTED TOMOGRAPHY COUCH PAD FOR MIN ANALYSIS
K852510 · KGI
Image Analysis, Inc.
Radiology · 128d
Cleared Oct 18, 1985
5X2 SATALEC CHIROPODY CASE
K853200
Spelna, Inc.
General & Plastic Surgery · 126d
Cleared Oct 18, 1985
MOBILE OPERATING TABLE FOR ORL MICROSURGERY
K853720 · GDC
Carl Zeiss, Inc.
General & Plastic Surgery · 43d
Cleared Oct 18, 1985
HEMED NEEDLE SUPPORT CATALOG NO. HAP-XXXX
K853731 · FMI
Gish Biomedical, Inc.
General Hospital · 42d
Cleared Oct 18, 1985
REPAIR KIT QUINTON TRIPLE LUMEN RIGHT ATRIAL CATHE
K853860 · DQY
Quinton, Inc.
Cardiovascular · 31d
Cleared Oct 18, 1985
CUI RHINOPLASTY IMPLANTS
K853945 · FZE
Cox-Uphuff Intl.
General & Plastic Surgery · 24d
Cleared Oct 18, 1985
ERIKA ARTERIAL LINE 03-9837-0
K853962 · FJK
National Medical Care, Medical...
Gastroenterology & Urology · 23d
Cleared Oct 18, 1985
EROSA DISPOSABLE HYPODERMIC NEEDLE
K853980 · GAA
Rose KG
General & Plastic Surgery · 21d
Cleared Oct 18, 1985
STERILE SOFT TISSUE BIOPSY NEEDLE
K854003 · GEE
Co-Medical, Inc.
General & Plastic Surgery · 18d
Cleared Oct 17, 1985
PHADEBACT CSF TEST
K844999 · GTJ
Pharmacia, Inc.
Chemistry · 295d