FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
30025–30048 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 17, 2016
LOGIQ E9, LOGIQ E9 XDClear 2.0
K163077 · IYN
GE Medical Systems Ultrasound and...
Radiology · 14d
Cleared Nov 16, 2016
Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)
K160663 · MAX
Evolution Spine, LLC
Orthopedic · 252d
Cleared Nov 16, 2016
DuoCem
K160800 · EMA
Coltene/Whaledent AG
Dental · 238d
Cleared Nov 16, 2016
LenSX Laser System
K161288 · OOE
Alcon Laboratories, Inc.
Ophthalmic · 191d
Cleared Nov 16, 2016
Tyber Medical BioTy® Nanotopography Trauma Screw
K161597 · HWC
Tyber Medical, LLC
Orthopedic · 160d
Cleared Nov 16, 2016
Diode Laser Therapy Machine
K161692 · GEX
Beijing Adss Development Co., Ltd.
General & Plastic Surgery · 149d
Cleared Nov 16, 2016
Aixplorer
K161999 · IYN
Supersonic Imagine
Radiology · 119d
Cleared Nov 16, 2016
touchTymp
K162210 · ETY
Maico Diagnostics GmbH
Ear, Nose, Throat · 103d
Cleared Nov 16, 2016
iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert
K162231 · OHT
Cyden Limited
General & Plastic Surgery · 100d
Cleared Nov 16, 2016
CD HORIZON® Spinal System
K162379 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 84d
Cleared Nov 16, 2016
CAD/CAMouflage Milling Block
K162537 · EBF
Prismatik Dentalcraft, Inc.
Dental · 65d
Cleared Nov 16, 2016
syngo Application Software
K162541 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 65d
Cleared Nov 16, 2016
VenaCure EVLT NeverTouch Procedure Kit
K162914 · GEX
AngioDynamics, Inc.
General & Plastic Surgery · 30d
Cleared Nov 16, 2016
Xperius Ultrasound System
K163020 · IYN
Philips Health Care
Radiology · 16d
Cleared Nov 15, 2016
Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)
K153409 · FXX
Protect U Guard, LLC
General Hospital · 356d
Cleared Nov 15, 2016
SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact...
K153714 · HQD
Synergeyes, Inc.
Ophthalmic · 327d
Cleared Nov 15, 2016
Charisma
K160049 · EBF
Heraeus Kulzer, LLC, Mitsui Chemicals...
Dental · 309d
Cleared Nov 15, 2016
X-MIND trium
K160166 · OAS
De Gotzen S.R.L.
Radiology · 293d
Cleared Nov 15, 2016
HardyCHROM ESBL
K160512 · JSO
Hardy Diagnostics
Microbiology · 265d
Cleared Nov 15, 2016
AmorChem Titanium Porous Fixation Device
K160791 · HWC
Amorchem Holdings, Inc.
Orthopedic · 237d
Cleared Nov 15, 2016
Tablo Console
K160881 · KDI
Outset Medical, Inc.
Gastroenterology & Urology · 230d
Cleared Nov 15, 2016
Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)
K161494 · CGX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 167d
Cleared Nov 15, 2016
eUnity
K161515 · LLZ
Client Outlook, Inc.
Radiology · 166d
Cleared Nov 15, 2016
VLP Wrist Fracture System
K161665 · HRS
Smith & Nephew, Inc.
Orthopedic · 152d