FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

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

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175,820 results
30049–30072 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 27, 2017
3M Clear Tray Aligner
K163689 · NXC
3M Unitek Corporation
Dental · 30d
Cleared Jan 26, 2017
Zmaxx T Series
K161219 · EIH
Maxx Digm, Inc.
Dental · 272d
Cleared Jan 26, 2017
dynaMX™ Compression Plate
K161303 · HRS
Mx Orthopedics, Corp.
Orthopedic · 261d
Cleared Jan 26, 2017
ROCCIA® ACIF
K162587 · ODP
Silony Medical GmbH
Orthopedic · 132d
Cleared Jan 26, 2017
V.A.C.ULTA Negative Pressure Wound Therapy System
K162790 · OMP
Kci USA, Inc. (Kinetic Concepts, Inc.)
General & Plastic Surgery · 114d
Cleared Jan 26, 2017
KARL STORZ ICG Imaging System
K162882 · OWN
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 104d
Cleared Jan 26, 2017
ORTHOLOC® 3Di Ankle Fracture Plating System
K163044 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 87d
Cleared Jan 26, 2017
Onli Intermittent Catheter
K163179 · GBM
Hollister Incorporated
Gastroenterology & Urology · 73d
Cleared Jan 26, 2017
FastStroke
K163281 · JAK
Gef Medical Systems Scs
Radiology · 66d
Cleared Jan 26, 2017
FITBONE TAA
K163368 · HSB
Wittenstein Intens GmbH
Orthopedic · 57d
Cleared Jan 26, 2017
Multi Modality Viewer
K163574 · LLZ
Vital Images, Inc.
Radiology · 38d
Cleared Jan 26, 2017
Pantera LEO
K163660 · LOX
Biotronik, Inc.
Cardiovascular · 30d
Cleared Jan 26, 2017
IntraClude Intra-Aortic Occlusion Device
K163693 · DXC
Edwards Lifesciences, LLC
Cardiovascular · 29d
Cleared Jan 26, 2017
Allura Xper R9
K163715 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 27d
Cleared Jan 25, 2017
Altus Spine Interbody Fusion System
K160976 · MAX
Altus Partners, LLC
Orthopedic · 293d
Cleared Jan 25, 2017
StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis
K161273 · MBB
Biomet, Inc.
Orthopedic · 265d
Cleared Jan 25, 2017
Reliant Multistage Dilatation Balloon Catheter
K162226 · FGE
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 170d
Cleared Jan 25, 2017
PASS LP Spinal System
K162786 · NKB
Medicrea International SA
Orthopedic · 114d
Cleared Jan 25, 2017
PreludeSYNC Radial Compression Device
K162988 · DXC
Merit Medical Systems, Inc.
Cardiovascular · 90d
Cleared Jan 25, 2017
CrossFT Knotless Suture Anchor with Disposable Driver
K163258 · MBI
Conmed Corporation
Orthopedic · 65d
Cleared Jan 24, 2017
ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
K161466 · HSB
Orthofix Srl
Orthopedic · 242d
Cleared Jan 24, 2017
F&P InfoSmart
K161686 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 221d
Cleared Jan 24, 2017
Barrx Anorectal RFA Wand
K162802 · GEI
Covidien, LLC
General & Plastic Surgery · 111d
Cleared Jan 24, 2017
eLyx-PRO
K162851 · GEX
Intelligent Sensory Concept SA
General & Plastic Surgery · 105d