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
75889–75912 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 04, 2002
TEMPORARY CROWN AND BRIDGE MATERIAL
K020157 · EBG
J. Morita USA, Inc.
Dental · 46d
Cleared Mar 04, 2002
INVIGRA
K020223 · HIS
Indus Medicare , Ltd.
Obstetrics & Gynecology · 41d
Cleared Mar 04, 2002
ENDOPATH DILATING TIP TROCAR, MODEL #512XD
K020428 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 24d
Cleared Mar 04, 2002
TRIDENT ELEVATED RIM LINER
K020497 · LPH
Howmedica Osteonics Corp.
Orthopedic · 18d
Cleared Mar 04, 2002
ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM
K020572 · MEH
Howmedica Osteonics Corp.
Orthopedic · 11d
Cleared Mar 01, 2002
AESCULAP -MIETHKE SHUNT SYSTEM
K011030 · JXG
Aesculap, Inc.
Neurology · 330d
Cleared Mar 01, 2002
DRG DISPOSABLE VAGINAL SPECULUM
K012535 · HIB
Doctor'S Research Group, Inc.
Obstetrics & Gynecology · 206d
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