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
72121–72144 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 18, 2003
SILVERLEAF CONTACT WOUND DRESSING
K013936 · FRO
Silverleaf Technologies, Inc.
General & Plastic Surgery · 475d
Cleared Mar 18, 2003
URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K022096 · KNK
Bayer Diagnostics Corp.
Chemistry · 264d
Cleared Mar 18, 2003
DSG RELAXER SPLINT
K022627 · MQC
Sentage Corporation D/B/A/ Dental...
Dental · 223d
Cleared Mar 18, 2003
XYLOS SURGICAL MESH
K023237 · FTM
Xylos Corporation
General & Plastic Surgery · 172d
Cleared Mar 18, 2003
LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP,...
K023472 · GXZ
Class A Enterprises, Inc.
Neurology · 153d
Cleared Mar 18, 2003
ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES
K023954 · GEX
Altus Medical, Inc.
General & Plastic Surgery · 111d
Cleared Mar 18, 2003
SIGHTFIX
K024251 · GCJ
World of Medicine Lemke GmbH
General & Plastic Surgery · 85d
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