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
158425–158448 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 1983
RICHARDS INTRA-ARTICULAR SHAVER BLADES
K830153 · GEY
Richard'S Medical Equip., Inc.
General & Plastic Surgery · 41d
Cleared Feb 28, 1983
REFEREE BLOOD GAS ANALYZER CONTROLS
K830181 · JJS
Analytical Products, Inc.
Chemistry · 41d
Cleared Feb 28, 1983
LYSIS +
K830186 · GGK
Hematology Marketing Assoc.
Pathology · 40d
Cleared Feb 28, 1983
NON-STERILE,SINGLE/SOUBLE LUMEN-CATH
K830233 · LJS
Evermed, Inc.
General Hospital · 34d
Cleared Feb 28, 1983
CVT VIRAL TRANSPORTS
K830250 · JTW
Immulok, Inc.
Microbiology · 34d
Cleared Feb 28, 1983
CAMPY BLOOD AGAR PLATE
K830251 · JSI
Granite Diagnostics, Inc.
Microbiology · 34d
Cleared Feb 28, 1983
COUNTWAY SYS. SOILED SPONGES-BLOOD LOS
K830273 · FQA
Ritmed, Inc.
General Hospital · 34d
Cleared Feb 28, 1983
LITHIUM DILUENT
K830283 · JIS
Shaban Mfg. Co.
Chemistry · 33d
Cleared Feb 28, 1983
ULTRA ZYME PLUS GAMMA GT #65055 & 56
K830308 · JQB
Emd Chemicals, Inc.
Chemistry · 28d
Cleared Feb 28, 1983
ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDASE
K830309 · CHH
Emd Chemicals, Inc.
Chemistry · 28d
Cleared Feb 28, 1983
LYSOSTAPHIN REAGENT SET
K830323 · JTO
Remel Co.
Microbiology · 28d
Cleared Feb 28, 1983
NEGATIVE PRESSURE ARTERIAL BLOOD LINE
K830326 · KDC
Erika, Inc.
General & Plastic Surgery · 27d
Cleared Feb 28, 1983
POLYETHYLENE MONITORING CONNECTORS
K830420 · DQO
Vertex Medical Corp.
Cardiovascular · 20d
Cleared Feb 28, 1983
LIFELINE UNIPOLAR J-LEAD #483-05
K830463 · DTB
Intermedics, Inc.
Cardiovascular · 10d
Cleared Feb 25, 1983
INHALANT PROFILE-ALLERGEN-SPECIFIC IGE
K823593 · DHB
Mast Immunosystems
Immunology · 81d
Cleared Feb 25, 1983
TANDEM-E -FER IMMUNOENZYMETRIC KIT
K823871 · DBF
Hybritech, Inc.
Chemistry · 64d
Cleared Feb 25, 1983
ALKALINE PHOSPHATES ISOENZYME SUBSTRATE
K830118 · CIN
Corning Medical & Scientific
Chemistry · 45d
Cleared Feb 25, 1983
TRIGLYCERIDE DIAGNOSTIC KIT
K830288 · CDT
Sclavo, Inc.
Chemistry · 29d
Cleared Feb 25, 1983
STRATUS FLUOROMETRIC ENZYME IMMUN0-
K830301 · JJE
American Hospital Supply Corp.
Chemistry · 28d
Cleared Feb 25, 1983
SECURA SET VOLUME LIMITING SET
K830448 · FPA
Diatek, Inc.
General Hospital · 10d
Cleared Feb 24, 1983
MULTI-PRONG FETAL SCALP ELECTRODE
K822584 · HGP
Kontron Instruments, Inc.
Obstetrics & Gynecology · 182d
Cleared Feb 24, 1983
AO DOCUSTAR(MMIRO) FUNDUS CAMERA
K822991 · HKI
Warner-Lambert Co.
Ophthalmic · 135d
Cleared Feb 24, 1983
NOSITE UV INTERIM SPECTACLES
K823825 · HQG
Patton, Boggs & Blow
Ophthalmic · 66d
Cleared Feb 24, 1983
COMPUTERIZED SPIROMETRY SYSTEM
K823922 · BZK
Ohio Medical Products
Anesthesiology · 58d