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

Filters: Cleared only ×
175,820 results
32281–32304 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 21, 2016
Pantheris Catheter
K160827 · MCW
Avinger, Inc.
Cardiovascular · 27d
Cleared Apr 20, 2016
NuVasive® Interfixated Interbody System
K160051 · OVD
Nu Vasive, Incorporated
Orthopedic · 100d
Cleared Apr 20, 2016
Leksell Gamma Knife Icon
K160440 · IWB
Elekta Instrument AB
Radiology · 63d
Cleared Apr 20, 2016
Elite SPK, Compasso, Elite SPK Kit
K160500 · MBI
Ncs Lab Srl
Orthopedic · 57d
Cleared Apr 20, 2016
Penumbra Smart Coil
K160832 · HCG
Penumbra, Inc.
Neurology · 26d
Cleared Apr 19, 2016
Arthrex Univers Revers CA Heads and Adapters
K151527 · HSD
Arthrex, Inc.
Orthopedic · 316d
Cleared Apr 19, 2016
VASOVIEW HemoPro Endoscopic Vessel Harvesting System
K153194 · GEI
Maquet Cardiovascular, LLC
General & Plastic Surgery · 167d
Cleared Apr 19, 2016
Bicortical Fixation Screw & Washer Nut System
K153638 · HWC
First Ray, LLC
Orthopedic · 123d
Cleared Apr 19, 2016
Microcyn Plus Skin and Wound Hydrogel
K153648 · FRO
Oculus Innovative Sciences
General & Plastic Surgery · 120d
Cleared Apr 19, 2016
Icare ic100
K153694 · HKY
Icare Finland OY
Ophthalmic · 118d
Cleared Apr 19, 2016
LumenR Tissue Retractor System
K153698 · ODB
Lumenr, LLC
Gastroenterology & Urology · 118d
Cleared Apr 19, 2016
AIRO Computed Tomography (CT) X-ray System
K160126 · JAK
Mobius Imaging
Radiology · 90d
Cleared Apr 19, 2016
Fujifilm Sonosite Vevo MD Imaging System
K160674 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 40d
Cleared Apr 18, 2016
Pulse Oximeter (MD300M/MD300K2)
K152563 · DQA
Beijing Choice Electronic Technology...
Anesthesiology · 222d
Cleared Apr 18, 2016
Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel...
K153192 · DJG
Chemtron Biotech, Inc.
Toxicology · 167d
Cleared Apr 15, 2016
Applanation Tonometer
K142263 · HKY
Shanghai Mediworks Precision...
Ophthalmic · 610d
Cleared Apr 15, 2016
VERASENSE Knee System
K150372 · ONN
Orthosensor, Inc.
Orthopedic · 427d
Cleared Apr 15, 2016
Spectra S1Plus and Spectra S2 Plus
K150476 · HGX
Uzinmedicare Co.
Obstetrics & Gynecology · 416d
Cleared Apr 15, 2016
Simple T Pediatric Nasal Mask
K151120 · BZD
Respironics, Inc.
Anesthesiology · 354d
Cleared Apr 15, 2016
Rainbow Paste Stain
K151731 · EIH
Genoss
Dental · 294d
Cleared Apr 15, 2016
SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber,...
K151855 · GEX
Surgical Laser Incorporated
General & Plastic Surgery · 282d
Cleared Apr 15, 2016
BiNAPS Nasal Airflow and Snore Transducer
K151874 · MNR
Salter Labs
Anesthesiology · 281d
Cleared Apr 15, 2016
StimSox(TM) System
K151922 · IPF
Stimmed, LLC
Physical Medicine · 277d
Cleared Apr 15, 2016
VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)
K152075 · LON
bioMerieux, Inc.
Microbiology · 263d