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
73249–73272 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 18, 2003
WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006
K024305 · JIX
Wiener Laboratories Saic
Chemistry · 84d
Cleared Mar 18, 2003
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER ACCESSORY CABLES
K030005 · DSA
Vanguard Medical Concepts, Inc.
Cardiovascular · 75d
Cleared Mar 18, 2003
VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30,...
K030096 · HRX
Arthrex, Inc.
Orthopedic · 67d
Cleared Mar 18, 2003
DUOMED, SERIES 500, (MODELS ID 500, FL 500)
K030140 · GZJ
Duomed, Inc.
Neurology · 63d
Cleared Mar 18, 2003
VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7
K030626 · DCK
Ortho-Clinical Diagnostics, Inc.
Immunology · 19d
Cleared Mar 17, 2003
BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BIOPSY SITE MARKER
K023694 · NEU
Biopsy Sciences, LLC
General & Plastic Surgery · 136d
Cleared Mar 17, 2003
NEOSPORIN SCAR SOLUTION
K024160 · MDA
Warner-Lambert Co.
General & Plastic Surgery · 90d
Cleared Mar 17, 2003
ALTON PT STEPPER
K024183 · KXK
Alton Design, LLC
Radiology · 88d
Cleared Mar 17, 2003
FENESTRATED INFUSION CATHETER
K024190 · FRN
Promedic, Inc.
General Hospital · 88d
Cleared Mar 17, 2003
DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER
K024235 · DQA
Dolphin Medical, Inc.
Anesthesiology · 84d
Cleared Mar 17, 2003
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K024357 · LTT
Trek Diagnostic Systems, Inc.
Microbiology · 77d
Cleared Mar 17, 2003
SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW)
K024364 · MQP
Synthes (Usa)
Orthopedic · 76d
Cleared Mar 17, 2003
SUPERBOND
K030161 · EJH
American Dent-All, Inc.
Dental · 60d
Cleared Mar 17, 2003
SUTURTEK FASTCLOSE SUTURING DEVICE
K030227 · GAL
Suturtek Incorporated
General & Plastic Surgery · 54d
Cleared Mar 17, 2003
BARD AQUAGUIDE URETERAL CONDUIT
K030438 · FED
C.R. Bard, Inc.
Gastroenterology & Urology · 34d
Cleared Mar 17, 2003
MODIFICATION TO CONTOUR POLARIS URETERAL STENT
K030503 · FAD
Boston Scientific Corp
Gastroenterology & Urology · 26d
Cleared Mar 17, 2003
MODULEAF
K030609 · IXI
Mrc Systems GmbH
Radiology · 19d
Cleared Mar 17, 2003
SAS RSV CONTROL KIT
K030628 · JJX
Sa Scientific, Inc.
Chemistry · 18d
Cleared Mar 14, 2003
SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT
K024124 · KDI
Chf Solutions, Inc.
Gastroenterology & Urology · 88d
Cleared Mar 14, 2003
ORAMAGICRX ORAL WOUND RINSE
K024180 · OLR
Mpm Medical., Inc.
General & Plastic Surgery · 86d
Cleared Mar 14, 2003
IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP,...
K024199 · FTL
Osteobiologics, Inc.
General & Plastic Surgery · 84d
Cleared Mar 14, 2003
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K024275 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 81d
Cleared Mar 14, 2003
GISH TUBING AND CONNECTORS WITH GBS COATING
K030077 · DTL
Gish Biomedical, Inc.
Cardiovascular · 65d
Cleared Mar 14, 2003
POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES
K030228 · KGO
Pt. Medisafe Technologies
General Hospital · 51d