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
33697–33720 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 13, 2015
ComboCath OTW PTA Dilatation Catheter
K150452 · LIT
Summa Therapeutics, LLC
Cardiovascular · 174d
Cleared Aug 13, 2015
Stryker Suture Tape
K150584 · GAT
Stryker
General & Plastic Surgery · 157d
Cleared Aug 13, 2015
Modpod
K150695 · ITH
Hollywog, LLC
Physical Medicine · 148d
Cleared Aug 13, 2015
CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial)
K150703 · KLE
Kuraray Noritake Dental, Inc.
Dental · 148d
Cleared Aug 13, 2015
Foundation Interbody Devices
K150847 · ODP
Corelink, LLC
Orthopedic · 135d
Cleared Aug 13, 2015
Aesculap T-Space PEEK and XP Spinal System
K151056 · MAX
Aesculap Implant Systems, LLC
Orthopedic · 115d
Cleared Aug 13, 2015
IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID
K151142 · EBI
Wieland Dental + Technik GmbH & Co. KG
Dental · 106d
Cleared Aug 13, 2015
STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral...
K151200 · GAM
Ethicon, Inc.
General & Plastic Surgery · 100d
Cleared Aug 13, 2015
Airlock® osteosynthesis plate system
K151277 · HRS
Novastep
Orthopedic · 91d
Cleared Aug 13, 2015
U2 Hip Stem, Ti Porous Coated, Matrix
K151316 · LPH
United Orthopedic Corporation
Orthopedic · 87d
Cleared Aug 13, 2015
Conventus PRS System
K151379 · HRS
Conventus Orthopaedics, Inc.
Orthopedic · 83d
Cleared Aug 13, 2015
syngo.via RT Image Suite
K151380 · MUJ
Siemens Medical Solutions USA, Inc.
Radiology · 83d
Cleared Aug 13, 2015
Continuum and Trilogy Integrated Taper (IT) Acetabular Systems
K151448 · LPH
Zimmer, Inc.
Orthopedic · 76d
Cleared Aug 13, 2015
Respiratory Gating for Scanners
K151533 · JAK
Varian Medical Systems, Inc.
Radiology · 66d
Cleared Aug 13, 2015
Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
K151642 · JXM
Healgen Scientific, LLC
Chemistry · 56d
Cleared Aug 13, 2015
Reusable Full Silicone Cover
K151702 · LIX
Laerdal Medical AS
Cardiovascular · 50d
Cleared Aug 13, 2015
Arc Endocuff Vision
K151801 · FED
Boddingtons Plastics, Ltd.
Gastroenterology & Urology · 42d
Cleared Aug 13, 2015
Turnpike catheter
K151981 · DQY
Vascular Solution, Inc.
Cardiovascular · 27d
Cleared Aug 12, 2015
Spaulding Electrocardiograph 2100iQ
K150564 · DPS
Spaulding Clinical Research, LLC
Cardiovascular · 159d
Cleared Aug 12, 2015
Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System,...
K151064 · OVE
Biomet Spine
Orthopedic · 114d
Cleared Aug 12, 2015
Arthrex BioSync® Bone Wedge
K151256 · PLF
Arthex, Inc.
Orthopedic · 92d
Cleared Aug 12, 2015
RECON system
K151407 · HRS
Normed Medizin-Technik GmbH
Orthopedic · 78d
Cleared Aug 12, 2015
SI-TECHNOLOGY® SI-DESIS® SCREWS
K151462 · OUR
Si-Technology, LLC
Orthopedic · 72d
Cleared Aug 12, 2015
RS80A Diagnostic Ultrasound System
K151663 · IYN
Samsung Medison Co., Ltd.
Radiology · 54d