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
77017–77040 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 2002
KONICA DIRECT DIGITIZER REGIUS MODEL 350
K013054 · MQB
Konica Minolta Medical & Graphic, Inc.
Radiology · 171d
Cleared Mar 01, 2002
MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON
K013737 · FGE
Telemed Systems, Inc.
Gastroenterology & Urology · 108d
Cleared Mar 01, 2002
REPROCESSED DISPOSABLE TROCARS
K013987 · KBG
Adven Medical
Ear, Nose, Throat · 87d
Cleared Mar 01, 2002
MODIFICATION TO EBI XFIX DFS SYSTEM
K014276 · KTT
Ebi, L.P.
Orthopedic · 64d
Cleared Mar 01, 2002
SAFETOUCH
K014300 · NHM
James D Rusin MD, MBA
Obstetrics & Gynecology · 60d
Cleared Mar 01, 2002
ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500
K020128 · JHI
Diagnostic Systems Laboratories, Inc.
Chemistry · 45d
Cleared Mar 01, 2002
MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT...
K020340 · DQX
Guidant Corp.
Cardiovascular · 28d
Cleared Mar 01, 2002
MODIFICATION TO VIGIL LIPID CONTROL
K020521 · JJY
Beckman Coulter, Inc.
Chemistry · 10d
Cleared Feb 28, 2002
CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM
K012357 · MOI
Bayer Diagnostics Corp.
Immunology · 218d
Cleared Feb 28, 2002
RESPIRONICS HEATED HUMIDIFIER
K012633 · BTT
Respironics, Inc.
Anesthesiology · 199d
Cleared Feb 28, 2002
ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES, ELECTROSURGICAL WANDS
K012640 · HRX
Medical Instruments Technology, Inc.
Orthopedic · 199d
Cleared Feb 28, 2002
SOF-TACT DIABETES MANAGEMENT SYSYEM
K012975 · NBW
Abbott Laboratories
Chemistry · 176d
Cleared Feb 28, 2002
BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)
K013148 · MYA
Biogenex Laboratories
Pathology · 161d
Cleared Feb 28, 2002
URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM
K013819 · JTW
Sierra Diagnostic, LLC
Microbiology · 104d
Cleared Feb 28, 2002
SANDHILL SCIENTIFIC PEDIATEC PH PROBE
K013951 · FFT
Sandhill Scientific, Inc.
Gastroenterology & Urology · 90d
Cleared Feb 28, 2002
INTUITIVE SURGICAL STERO VIEW ENDOSCOPIC SYSTEM
K013952 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 90d
Cleared Feb 28, 2002
LORENZ SELF DRILLING SCREWS
K013954 · HWC
Walter Lorenz Surgical, Inc.
Orthopedic · 90d
Cleared Feb 28, 2002
MODEL 9210 DELIVERY CATHETER, MODEL 9210
K013963 · DQY
Medtronic Vascular
Cardiovascular · 87d
Cleared Feb 28, 2002
APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE
K014047 · GCJ
Applied Medical Resources Corp.
General & Plastic Surgery · 83d
Cleared Feb 28, 2002
SATARI POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM...
K014110 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 76d
Cleared Feb 28, 2002
SATARI LATEX PATIENT EXAMINATION POWDERED GLOVE SINGLE SIDE POLYMER COATED,...
K014112 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 76d
Cleared Feb 28, 2002
UNITE BONDING ADHESIVE
K014142 · DYH
3M Unitek
Dental · 73d
Cleared Feb 28, 2002
ABX MICROS 60 HEMATOLOGY ANALYZER
K014203 · GKX
Abx Diagnostics
Hematology · 69d
Cleared Feb 28, 2002
STAT PROFILE PHOX ANALYZER
K014295 · CHL
Nova Biomedical Corp.
Chemistry · 62d