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

Filters: Cleared only ×
176,076 results
157609–157632 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 18, 1983
HOME PREGNANCY TEST KIT
K831108 · LCX
Quidel Corp.
Chemistry · 43d
Cleared May 18, 1983
STRAIGHT 5 HEMOSTAT
K831137 · HTD
Almore Intl., Inc.
General & Plastic Surgery · 41d
Cleared May 18, 1983
CURVED HEMOSTAT 5
K831138 · HTD
Almore Intl., Inc.
General & Plastic Surgery · 41d
Cleared May 18, 1983
PULSE LAVAGE
K831230
Micro-Aire Surgical Instruments, Inc.
General & Plastic Surgery · 33d
Cleared May 18, 1983
TUMISTORE RECORDER 1311
K831252 · LIL
Life-Tech Intl., Inc.
Gastroenterology & Urology · 30d
Cleared May 18, 1983
BIOPSY ATTACHMENT
K831317 · FCI
Diasonics, Inc.
Gastroenterology & Urology · 26d
Cleared May 18, 1983
MODIFIED NEW YORK MEDIUM
K831359 · JTY
Gibco Laboratories Life Technologies,...
Microbiology · 22d
Cleared May 18, 1983
MODEL ND1100 BONE DENSITY SCANNER
K837230
Molsgaard Medical
Radiology · 12d
Cleared May 18, 1983
SHARPLAN 721 CO2 SURGICAL LASER
K837342
Laser Industries , Ltd.
Radiology · 71d
Cleared May 18, 1983
OMNIMEDICAL QUAD II DIGITAL ANGIOGRAPH SYSTEM
K837378
Omnimedical
Radiology · 62d
Cleared May 18, 1983
AUTO D OPTION
K837430
Technicare Corp.
Radiology · 19d
Cleared May 17, 1983
STRATUS DIGOXIN FLUOROMETRIC ENZYME IMM-
K831177 · KXT
American Dade
Immunology · 36d
Cleared May 16, 1983
LUS ACETABULAR COMPONENT
K830209 · JDI
Biomet, Inc.
Orthopedic · 112d
Cleared May 16, 1983
DIFF 4 SYSTEM
K830441 · EKZ
Coulter Electronics, Inc.
Hematology · 95d
Cleared May 16, 1983
PLATELET AGGREGOMETER
K830749 · JBX
Chrono-Log Corp.
Hematology · 68d
Cleared May 16, 1983
SYRINGE 500BC BE #7000
K830898 · BXW
Instrumentation Industries, Inc.
Anesthesiology · 56d
Cleared May 16, 1983
OCUCARE PACK
K830902 · HQC
Ocular Innovations, Inc.
Ophthalmic · 56d
Cleared May 16, 1983
EXTRELUT QE EXTRACTION COLUMNS
K831027 · KEA
Emd Chemicals, Inc.
Toxicology · 47d
Cleared May 16, 1983
CHEMONUCLEOLYSIS TABLE EXTENSION
K831042 · FSE
Orthopedic Systems, Inc.
General & Plastic Surgery · 46d
Cleared May 16, 1983
EZEE FILTER/SEPARATOR
K831081 · JKA
The Kendall Company Div. of Tyco...
Chemistry · 42d
Cleared May 16, 1983
APELLO, PERSONAL HEALTH SUPPORT SYS.
K831093 · ILQ
Almicro Electronics, Inc.
Physical Medicine · 42d
Cleared May 16, 1983
CORDIA PAP
K831105 · JFH
Cordis Corp.
Immunology · 41d
Cleared May 16, 1983
OXYCOIL
K831146 · BYX
Channing Corp.
Anesthesiology · 38d
Cleared May 16, 1983
STRATUS PHENYTOIN FLUOROMETRIC ENZYME
K831154 · LES
American Dade
Immunology · 38d