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
168265–168288 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 1980
CAMPY THIO
K792676 · JSJ
Remel Co.
Microbiology · 28d
Cleared Jan 24, 1980
IMMUNODIFFUSION BAND INTENSIFYING FLUID
K792692 · GMK
Meridian Diagnostics, Inc.
Immunology · 28d
Cleared Jan 24, 1980
NEGATIVE CONTROL SERUM
K792694 · GMK
Meridian Diagnostics, Inc.
Microbiology · 28d
Cleared Jan 24, 1980
ANTI-GLOBULIN CONTROL
K792695 · DHR
Meridian Diagnostics, Inc.
Immunology · 28d
Cleared Jan 24, 1980
NORMAL GLOBULIN REAGENT
K792697 · DHR
Meridian Diagnostics, Inc.
Immunology · 28d
Cleared Jan 24, 1980
OUCHTERLONY AGAR PLATES
K792699 · JZQ
Meridian Diagnostics, Inc.
Immunology · 28d
Cleared Jan 24, 1980
VASPAR SEALANT
K792702 · KEQ
Meridian Diagnostics, Inc.
Pathology · 28d
Cleared Jan 24, 1980
LACTO-PHENOL ANALINE BLUE FLUID
K792703 · KEQ
Meridian Diagnostics, Inc.
Radiology · 28d
Cleared Jan 24, 1980
PARA-PAK(WHEATLEY'S TRICHROME STAIN)
K792706 · HYW
Meridian Diagnostics, Inc.
Pathology · 28d
Cleared Jan 24, 1980
KOH MOUNTING FLUID W/GLYCEROL
K792709 · KEQ
Meridian Diagnostics, Inc.
Pathology · 28d
Cleared Jan 24, 1980
PARA-PAK PVA
K792714 · IFQ
Meridian Diagnostics, Inc.
Pathology · 28d
Cleared Jan 24, 1980
CANDIDA ALBICANS, ANTIGEN
K792716 · GMI
Meridian Diagnostics, Inc.
Microbiology · 28d
Cleared Jan 24, 1980
NOVAMETRIX CPAP NASAL CANNULA
K792722 · BZD
Novametrix Medical Systems, Inc.
Anesthesiology · 24d
Cleared Jan 24, 1980
ANITOMIC TOTAL HIP SYSTEM
K800050 · JDG
Hexcel Medical
Orthopedic · 15d
Cleared Jan 24, 1980
VENTILATOR SET
K800056 · BTT
Abbott Laboratories
Anesthesiology · 14d
Cleared Jan 24, 1980
NEBULIZER TUBING SET
K800083 · CAF
Abbott Laboratories
Anesthesiology · 10d
Cleared Jan 24, 1980
VENTILATOR TEST LUNG
K800125 · CBK
Bio-Med Devices, Inc.
Anesthesiology · 6d
Cleared Jan 23, 1980
FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD
K792249 · GOL
Intl. Diagnostic Technology
Microbiology · 77d
Cleared Jan 23, 1980
CUTTER POINTS
K792250 · EHL
Cutter Laboratories, Inc.
Dental · 76d
Cleared Jan 23, 1980
BIOPHASE IMPLANT MATERIAL
K792329 · JDG
Richard'S Medical Equip., Inc.
Orthopedic · 65d
Cleared Jan 23, 1980
WIDEX HEARING AID MODEL S10
K792389 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 58d
Cleared Jan 23, 1980
COE-SIL
K792428 · LDG
Coe Laboratories, Inc.
Ear, Nose, Throat · 57d
Cleared Jan 23, 1980
CARDIASSIST EXTERNAL COUNTERPULSATION
K792430 · DRN
Cardiassist Corp.
Cardiovascular · 57d
Cleared Jan 23, 1980
INTERSCI TEST FOR ALCOHOL IN BODY FLUIDS
K792469 · DOJ
Intersci Corp.
Toxicology · 51d