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
30625–30648 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 15, 2016
Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid
K161742 · PHX
Tornier, Inc.
Orthopedic · 144d
Cleared Nov 15, 2016
Hoffman LRF System
K161753 · KTT
Stryker GmbH
Orthopedic · 144d
Cleared Nov 15, 2016
IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set
K161831 · MRG
Immunodiagnostic Systems , Ltd.
Chemistry · 133d
Cleared Nov 15, 2016
StatStrip Xpress Glucose Hospital Meter System
K161856 · PZI
Nova Biomedical Corporation
Chemistry · 132d
Cleared Nov 15, 2016
CushionCast Moldable Cushions
K162265 · IYE
Izi Medical Products, LLC
Radiology · 96d
Cleared Nov 15, 2016
Digital Diagnostic Mobile X-ray System
K162278 · IZL
Samsung Electronics Co., Ltd.
Radiology · 92d
Cleared Nov 15, 2016
Achieve Advance Mapping Catheter
K162892 · DRF
Medtronic, Inc.
Cardiovascular · 29d
Cleared Nov 15, 2016
AccuCath Intravascular Catheter
K162894 · FOZ
C.R. Bard, Inc.
General Hospital · 29d
Cleared Nov 15, 2016
Optima XR240amx
K162990 · IZL
Ge Medical Systems, LLC
Radiology · 19d
Cleared Nov 14, 2016
PathLoc-SI Joint Fusion System
K153656 · OUR
L & K Biomed Co., Ltd.
Orthopedic · 329d