FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
80305–80328 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 26, 2001
POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE
K010072 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 17d
Cleared Jan 25, 2001
GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04
K001624 · MLY
Gebauer Co.
Physical Medicine · 244d
Cleared Jan 25, 2001
PVA FOAM EMBOLIZATION PARTICLES
K001678 · HCG
Surgica Corp.
Neurology · 238d
Cleared Jan 25, 2001
STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE
K001961 · DWF
Stoeckert Instrumente
Cardiovascular · 212d
Cleared Jan 25, 2001
INTRODEUCE DOUBLE LUMEN INTRODUCER
K001985 · DYB
Cook, Inc.
Cardiovascular · 210d
Cleared Jan 25, 2001
SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS
K002007 · DSY
Sulzer Carbomedics, Inc.
Cardiovascular · 206d
Cleared Jan 25, 2001
FMP METAL/METAL ACETABULAR INSERT
K003250 · KWA
Encore Orthopedics, Inc.
Orthopedic · 100d
Cleared Jan 25, 2001
WELCH ALLYN 11800 OPTHALMOSCOPE
K003376 · HLI
Welch Allyn, Inc.
Ophthalmic · 87d