FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
79777–79800 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 2001
APPALEAD GW+03XXXXXXR SERIES
K003394 · DQX
Nipro Medical Corp.
Cardiovascular · 90d
Cleared Jan 30, 2001
CT PERFUSION 2
K010042 · JAK
General Electric Co.
Radiology · 25d
Cleared Jan 29, 2001
BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520
K001543 · DXN
Welch Allyn, Inc.
Cardiovascular · 257d
Cleared Jan 29, 2001
STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE
K002273 · DWF
Stoeckert Instrumente
Cardiovascular · 187d
Cleared Jan 29, 2001
LIQUIDERM LIQUID ADHESIVE BANDAGE
K002338 · KMF
Closure Medical Corp.
General & Plastic Surgery · 181d
Cleared Jan 29, 2001
NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM
K002791 · DXN
Unix Electronic Co. , Ltd.
Cardiovascular · 144d
Cleared Jan 29, 2001
BIOTEQUE VAGINAL DILATOR
K003380 · HDX
Bioteque America, Inc.
Obstetrics & Gynecology · 90d
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