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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
35713–35736 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 2015
PANAVIA SA Cement Plus Handmix
K142623 · EMA
Kuraray Noritake Dental, Inc.
Dental · 163d
Cleared Feb 26, 2015
UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON...
K142985 · JIT
Beckman Coulter, Inc.
Chemistry · 133d
Cleared Feb 26, 2015
Ancora LLC Interbody Fusion Device
K143228 · OVD
Frontier Medical Devices, Inc.
Orthopedic · 108d
Cleared Feb 26, 2015
OS2-V Varisation Staple
K143323 · JDR
In2bones Sas
Orthopedic · 99d
Cleared Feb 26, 2015
IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000...
K143373 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 93d
Cleared Feb 26, 2015
Air Bubble Based Infuser (ABBI)
K143415 · LKF
CooperSurgical, Inc.
Obstetrics & Gynecology · 90d
Cleared Feb 26, 2015
Vector PTA Balloon Dilatation Catheter
K143652 · LIT
Vector Corporation, LLC
Cardiovascular · 65d
Cleared Feb 26, 2015
First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test
K150162 · LAF
W.H.P.M., Inc.
Chemistry · 31d
Cleared Feb 26, 2015
EMMA
K150174 · NZH
Inrange Systems, Inc.
General Hospital · 31d
Cleared Feb 26, 2015
IntraTemp Solution Warmer
K150190 · LHC
Ecolab, Inc.
General Hospital · 30d
Cleared Feb 26, 2015
NIOX VERO Airway Inflammation Monitor
K150233 · MXA
Aerocrine AB
Chemistry · 24d
Cleared Feb 25, 2015
MCC Para-Fix CARY BLAIR MEDIUM
K141506 · JSM
Medical Chemical Corporation
Microbiology · 264d
Cleared Feb 25, 2015
Biomet Microfixation Thoracic Fixation System
K142823 · HRS
Biomet Microfixation
Orthopedic · 148d
Cleared Feb 25, 2015
Hospira Primary Sets
K143015 · FPA
Hospira, Inc.
General Hospital · 128d
Cleared Feb 25, 2015
GastriSail Gastric Positioning System
K143088 · KNT
Covidien
Gastroenterology & Urology · 120d
Cleared Feb 25, 2015
Palladian Lumbar Pedicle Screw System
K143230 · NKB
Neurostructures, Inc.
Orthopedic · 107d
Cleared Feb 25, 2015
Nile Alternative Fixation
K143350 · OWI
K2m, Inc.
Orthopedic · 93d
Cleared Feb 25, 2015
ANAX 5.5 Spinal System
K143417 · MNH
U&I Corporation
Orthopedic · 89d
Cleared Feb 25, 2015
IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE...
K143636 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 65d
Cleared Feb 25, 2015
Baide
K150009 · HRS
Jiangsu Baide Medical Intrument Co.,...
Orthopedic · 54d
Cleared Feb 25, 2015
Irritrol, EDS Combo-Rinse
K150020 · KJJ
Essential Dental Systesm, Inc.
Dental · 50d
Cleared Feb 25, 2015
CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids
K150179 · DJG
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 29d
Cleared Feb 25, 2015
CD HORIZON Growth Rod Conversion Set
K150200 · PGM
Medtronic Sofamor Danek USA,...
Orthopedic · 27d
Cleared Feb 24, 2015
T-8000 THEROZONE UNIT
K141504 · EIA
Therozone USA, Inc.
Dental · 263d