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
163705–163728 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 27, 1981
BOUNDARY REINFORCED OR GOWN
K811958 · FYA
The Buckeye Cellulose Corp.
General Hospital · 18d
Cleared Jul 27, 1981
MODEL 480 VARIABLE WAVELENGTH ULTRA VIOL
K811975 · JJQ
Waters Assoc., Inc.
Radiology · 14d
Cleared Jul 27, 1981
OXY-QUIK MARK IV OXYGEN INHALATOR
K811987 · DRM
Oxequip Health Ind.
Cardiovascular · 14d
Cleared Jul 27, 1981
TRACH CLEANING TRAY
K811990 · FRL
Associated Medical Products Co.
General Hospital · 14d
Cleared Jul 27, 1981
RADIOIMMUNOASSAY LUTEINIZING HORMONE
K811994 · CEP
Endocrine-Metabolic Center
Chemistry · 13d
Cleared Jul 27, 1981
A-GENT THEOPHYLLINE
K812003 · KLS
Abbott Laboratories
Chemistry · 13d
Cleared Jul 24, 1981
PLA-MATE
K803071 · GKL
Labex, Inc.
Chemistry · 231d
Cleared Jul 24, 1981
ELECTRONIC MUSCLE STIMULATOR
K811250 · IPF
Electrola
Physical Medicine · 80d
Cleared Jul 24, 1981
STIMULATOR, FACIAL-MODELS SF-100 & 200
K811502 · IPF
Rcx-Western, Inc.
Physical Medicine · 58d
Cleared Jul 24, 1981
R & S SERIES FITTING TOOLS
K811889 · EIC
Suncoast Dental Corp.
Dental · 23d
Cleared Jul 24, 1981
R & S SERIES IMPLANTS
K811923 · DZE
Suncoast Dental Corp.
Dental · 22d
Cleared Jul 23, 1981
PHADEBAS IGG RAST TEST
K810694 · DEW
Pharmacia, Inc.
Immunology · 129d
Cleared Jul 23, 1981
LABTRONIX PLATELET COUNTER(L/O/C.)
K811084 · GLG
Labtronix Corp.
Radiology · 93d
Cleared Jul 23, 1981
BASE METAL ALLOY
K811258 · EJH
Dentsply Intl.
Dental · 79d
Cleared Jul 23, 1981
ANTIBODY TO CHLAMYDIA TRACHOMATIS
K811570 · GPW
Electro-Nucleonics Laboratories, Inc.
Microbiology · 49d
Cleared Jul 23, 1981
ACCUDEX
K811680 · JJQ
Biodynamics Corp.
Chemistry · 38d
Cleared Jul 23, 1981
MODEL 4100 14 MEV NEUTRON GEN. THERAPY
K811778 · IWL
The Cyclotron Corp.
Radiology · 30d
Cleared Jul 23, 1981
UROPAPER EIKEN UAG
K811818 · JIL
Syn-Kit, Inc.
Microbiology · 27d
Cleared Jul 23, 1981
ESKAFLOW TEST FOR TRIGLYCERIDES
K811850 · CDT
Smithkline Diagnostics, Inc.
Chemistry · 22d
Cleared Jul 23, 1981
KING DIAGNOSTICS TOTAL BILIRUBIN TEST
K811881 · CIG
King Diagnostics, Inc.
Chemistry · 22d
Cleared Jul 23, 1981
KING DIAGNOSTICS GLUCOSE TEST
K811882 · CGA
King Diagnostics, Inc.
Chemistry · 22d
Cleared Jul 23, 1981
KING DIAGNOSTICS GLUCOSE-O TEST
K811883 · CGE
King Diagnostics, Inc.
Chemistry · 22d
Cleared Jul 23, 1981
CESIUM DILUENT 7.5M
K811886 · JGT
Gilford Diagnostics
Chemistry · 22d
Cleared Jul 23, 1981
LINDHOLM ANATOMICAL TRACHEAL TUBE
K811888 · BTR
Mallinckrodt Critical Care
Anesthesiology · 22d