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
78769–78792 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 06, 2001
NEUROTHERM, MODEL JK4
K011387 · GXI
Eurolink, LLC
Neurology · 122d
Cleared Sep 06, 2001
SYNTHES LCP PROXIMAL HUMERUS PLATES
K011815 · KTW
Synthes (Usa)
Orthopedic · 87d
Cleared Sep 06, 2001
STERILE EMG ELECTRODES
K011818 · IKT
Nicolet Biomedical, Inc.
Neurology · 87d
Cleared Sep 06, 2001
MODIFICATION TO THE I.C.O.S SCREW
K011821 · HWC
New Deal, S.A.
Orthopedic · 87d
Cleared Sep 06, 2001
BIOREHAB SYSTEM
K011823 · HCC
Nicolet Biomedical, Inc.
Neurology · 87d
Cleared Sep 06, 2001
MODIFICATION TO THE TAC' PIN
K011875 · JDW
New Deal, S.A.
Orthopedic · 83d
Cleared Sep 06, 2001
OPTIBOND SOLO PLUS 3
K011908 · EBC
Kerr Dental Materials Center
Dental · 79d
Cleared Sep 06, 2001
VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
K012050 · DQY
Guidant Corp.
Cardiovascular · 66d
Cleared Sep 06, 2001
3.25MM SPLINE TWIST IMPLANT
K012055 · DZE
Sulzer Dental, Inc.
Dental · 66d
Cleared Sep 06, 2001
JAS CARBON DIOXIDE LIQUID REAGENT
K012332 · KHS
Jas Diagnostics, Inc.
Chemistry · 45d
Cleared Sep 06, 2001
LC TEMPORARY FILLING
K012360 · EBG
Parkell, Inc.
Dental · 43d
Cleared Sep 06, 2001
PANAVIA F
K012441 · EMA
Kuraray Medical, Inc.
Dental · 37d
Cleared Sep 06, 2001
VERASTEP
K012539 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 30d
Cleared Sep 06, 2001
MODIFICATION TO: VECTORVISION FRAMELESS BIOPSY SYSTEM
K012564 · HAW
Brainlab AG
Neurology · 28d
Cleared Sep 06, 2001
GE VISION NUCLEAR MEDICINE WORKSTATION
K012568 · KPS
General Electric Co.
Radiology · 28d
Cleared Sep 06, 2001
MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT
K012584 · CAZ
Bd
Anesthesiology · 27d
Cleared Sep 06, 2001
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648
K012656 · JJT
Bio-Rad
Chemistry · 24d
Cleared Sep 05, 2001
JMS APHERESIS NEEDLE SET ACCORDION TYPE
K002394 · FMI
Jms Co., Ltd.
General Hospital · 394d
Cleared Sep 05, 2001
BRITESMILE BARRIER MATERIAL
K010935 · EIE
Britesmile, Inc.
Dental · 161d
Cleared Sep 05, 2001
OMNIDOS
K011763 · IYE
Scanditronix Medical AB
Radiology · 90d
Cleared Sep 05, 2001
R120 MODULAR TOTAL HIP SYSTEM
K011774 · JDI
Osteoimplant Technology, Inc.
Orthopedic · 90d
Cleared Sep 05, 2001
MICROCRUISER PLUS INTRODUCER SET
K011790 · DYB
Medical Device Technologies, Inc.
Cardiovascular · 89d
Cleared Sep 05, 2001
DENTORIUM CONVERTIBLE ACRYLIC
K011820 · EBI
Nats Corp.
Dental · 86d
Cleared Sep 05, 2001
MHS 5000
K011981 · LHQ
Micro Health Systems, Inc.
Radiology · 72d