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
80905–80928 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 29, 2001
COLLES C SERIES FRAME STERILE PACK
K003397 · KTT
DePuy Orthopaedics, Inc.
Orthopedic · 89d
Cleared Jan 29, 2001
CHASE CARDIOVASCULAR PATCH
K003467 · DXZ
Chase Medical, Inc.
Cardiovascular · 82d
Cleared Jan 29, 2001
YASARGIL PERMANENT ANEURYSM CLIPS
K003519 · HCH
Aesculap, Inc.
Neurology · 75d
Cleared Jan 29, 2001
STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT
K003577 · FST
STERIS Corporation
General & Plastic Surgery · 70d
Cleared Jan 29, 2001
DIRECT BILIRUBIN
K003693 · CIG
Jas Diagnostics, Inc.
Chemistry · 60d
Cleared Jan 29, 2001
EPI-DERM SILICONE GEL SHEETING
K003948 · MDA
Biodermis Corp.
General & Plastic Surgery · 39d
Cleared Jan 29, 2001
GUTHRIE SHIELD PLUS BLUE LATEX EXAMINATION GLOVES (POWDER-FREE)
K010078 · LYY
Guthrie Medicare Products (Melaka)...
General Hospital · 19d
Cleared Jan 28, 2001
CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX
K003375 · LTZ
Tecnilatex S.A.
Obstetrics & Gynecology · 90d
Cleared Jan 26, 2001
STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I
K002375 · LDJ
OraSure Technologies, Inc.
Toxicology · 175d
Cleared Jan 26, 2001
THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLOFACIAL SURGERY
K002426 · JEY
Bioplate, Inc.
Dental · 171d
Cleared Jan 26, 2001
SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII
K002652 · LOD
Stryker Corp.
Orthopedic · 154d
Cleared Jan 26, 2001
FORMULA ONE POWDERED LATEX EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING...
K002719 · LYY
Tillotson Healthcare Corp.
General Hospital · 148d
Cleared Jan 26, 2001
MEDLINE STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K003055 · LYY
Medline Industries, Inc.
General Hospital · 116d
Cleared Jan 26, 2001
SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER)
K003407 · EMA
Ivoclar North America, Inc.
Dental · 86d
Cleared Jan 26, 2001
ELECSYS FSH CALSET II
K003409 · JIT
Roche Diagnostics Corp.
Chemistry · 85d
Cleared Jan 26, 2001
STERILE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, WITH PROTEIN...
K003653 · LYY
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 60d
Cleared Jan 26, 2001
PATIENT DRAPE, SURGICAL
K003670 · KKX
Advance Medical Designs, Inc.
General Hospital · 59d
Cleared Jan 26, 2001
MEDCOMP Z-CATH
K003682 · LJS
Medical Components, Inc.
General Hospital · 57d
Cleared Jan 26, 2001
TIANXIE
K003748 · MQX
Suzhou Tianyi Acupuncture Instruments...
General Hospital · 53d
Cleared Jan 26, 2001
MODIFICATION TO FLUROTEX SURGICAL MESH
K003906 · FTL
Bridger Biomed, Inc.
General & Plastic Surgery · 38d
Cleared Jan 26, 2001
MODIFICATION TO FLUOROTEX II SURGICAL MESH
K003917 · FTL
Bridger Biomed, Inc.
General & Plastic Surgery · 38d
Cleared Jan 26, 2001
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200...
K003934 · LYY
Seltom Pacific Sdn. Bhd.
General Hospital · 37d
Cleared Jan 26, 2001
TEMPERATURE FUNCTION, MODEL 9500 MULTIGAS MONITOR
K003982 · CCK
Magnetic Resonance Equipment Corp.
Anesthesiology · 35d
Cleared Jan 26, 2001
GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT...
K010054 · LYY
Guthrie Medicare Products (Melaka)...
General Hospital · 18d