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
158017–158040 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 1983
IV STAND
K830474 · HQC
Teknar, Inc.
Ophthalmic · 49d
Cleared Apr 05, 1983
POLYSTYRENE MICROTITER PLATE IMMUNOSOR
K830495 · DGO
Diagnostic Reagent Tech.
Microbiology · 48d
Cleared Apr 05, 1983
PEM-T
K830497 · JWZ
Hedeco
Microbiology · 48d
Cleared Apr 05, 1983
LEECO TESTOSTERONE DIAGNOSTIC KIT
K830512 · CDZ
Leeco Diagnostics, Inc.
Chemistry · 47d
Cleared Apr 05, 1983
EMIT-ST PHOTOMETER & DILUTER VERIFICA
K830518 · DIF
Syva Co.
Toxicology · 47d
Cleared Apr 05, 1983
B-GCG SYSTEM BY RIA
K830526 · JHI
Pcl-Ria, Inc.
Chemistry · 47d
Cleared Apr 05, 1983
PHASE II DIGOXIN RADIOIMMUNOASSAY KIT
K830533 · DON
Medical & Scientific Designs, Inc.
Chemistry · 46d
Cleared Apr 05, 1983
CORNING 2500 CO-OXIMETER
K830590 · KHG
Corning Medical & Scientific
Hematology · 40d
Cleared Apr 05, 1983
ACTIVATED URIC ACID
K830616 · CHD
American Monitor Corp.
Chemistry · 36d
Cleared Apr 05, 1983
FLUOROMETER, GENERAL USE
K830624 · KHO
Abbott Diagnostics
Toxicology · 36d
Cleared Apr 05, 1983
POTASSIUM DILUENT
K830636 · JIH
Shaban Mfg. Co.
Toxicology · 35d
Cleared Apr 05, 1983
ENCORE CHEMISTRY ANALYZER
K830641 · JJG
Baker Instructions Corp.
Chemistry · 35d
Cleared Apr 05, 1983
PHASE THYROXINE RADIOIMMUNOASSAY KIT
K830642 · CDX
Medical & Scientific Designs, Inc.
Chemistry · 35d
Cleared Apr 05, 1983
FIAX COMPLEMENT C3 TEST KIT
K830668 · CZW
Intl. Diagnostic Technology
Immunology · 32d
Cleared Apr 05, 1983
CREATINE KINASE REAGENT SET
K830672 · JHY
Sterling Biochemical, Inc.
Chemistry · 32d
Cleared Apr 05, 1983
DUPONT PREP OD EXTRACTION CARTRIDE
K830692 · DJY
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 29d
Cleared Apr 05, 1983
DUPONT PREP TYPE AS EXTRACTION CARTRIDE
K830693 · DJY
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 29d
Cleared Apr 05, 1983
CARDIOTOMY RESERVOIR-FILTERED & NON
K830727 · DTP
Electromics, Inc.
Cardiovascular · 28d
Cleared Apr 05, 1983
FEKAL CON-TRATE SYSTEM
K830769 · KLI
Trend Scientific, Inc.
Chemistry · 25d
Cleared Apr 05, 1983
STERILE SURGICAL PAIN RELIEF ELECTRODE
K830798 · GXY
Lectec Corp.
Neurology · 22d
Cleared Apr 05, 1983
OB HELP ARM
K830842 · ILE
Lic-Orthion
Physical Medicine · 19d
Cleared Apr 05, 1983
RESI-WALKER
K830848 · ITJ
Lic-Orthion
Physical Medicine · 19d
Cleared Apr 05, 1983
OB TILT
K830849 · INQ
Lic-Orthion
Physical Medicine · 19d
Cleared Apr 05, 1983
OB TRIPP TRANSPORT CHAIR
K830850 · INM
Lic-Orthion
Physical Medicine · 19d