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

Filters: Cleared only ×
175,820 results
27313–27336 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 01, 2017
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam...
K172255 · LTT
Beckman Coulter, Inc.
Microbiology · 128d
Cleared Dec 01, 2017
MR Conditional Cup Electrode, MR Conditional Webb Electrode
K172503 · GXY
Rhythmlink International, LLC
Neurology · 105d
Cleared Dec 01, 2017
CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor
K172666 · OCW
Sutureease, Inc.
General & Plastic Surgery · 87d
Cleared Dec 01, 2017
LightWalker Laser System Family
K172819 · GEX
Fotona D.O.O.
General & Plastic Surgery · 74d
Cleared Dec 01, 2017
DUS-6000 Digital Ultrasonic Diagnostic Imaging System
K172931 · IYO
Advanced Instrumentations, Inc.
Radiology · 67d
Cleared Dec 01, 2017
CuRAS Nd:YAG Laser
K173038 · GEX
Ilooda Co,., Ltd.
General & Plastic Surgery · 64d
Cleared Dec 01, 2017
P10 Series Digital Color Doppler Ultrasound System
K173058 · IYN
Sonoscape Medical Corp.
Radiology · 64d
Cleared Dec 01, 2017
PRECICE System
K173129 · HSB
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 63d
Cleared Dec 01, 2017
ACIF
K173148 · ODP
Coligne AG
Orthopedic · 63d
Cleared Dec 01, 2017
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K173209 · JWY
Thermo Fisher Scientific
Microbiology · 60d
Cleared Dec 01, 2017
Octane aspiration system
K173266 · QEZ
Vascular Solutions, Inc.
Cardiovascular · 51d
Cleared Nov 30, 2017
Foot Drop System (Model XFT-2001D)
K162718 · GZI
Shenzhen Xft Medical Limited
Neurology · 427d
Cleared Nov 30, 2017
FIXIT Threaded Anchor System
K170868 · MAI
S.B.M Sas Science For Bio Materials
Orthopedic · 252d
Cleared Nov 30, 2017
NexSite HD, Hemodialysis Step Tip Catheter (60cm)
K171571 · MSD
Marvao Medical Devices, Ltd.
Gastroenterology & Urology · 184d
Cleared Nov 30, 2017
Infrared thermometer
K171578 · FLL
Shenzhen Aeon Technology Co., Ltd.
General Hospital · 183d
Cleared Nov 30, 2017
Birmingham Hip (BH) Dual Mobility Insert
K171934 · LPH
Smith & Nephew, Inc.
Orthopedic · 155d
Cleared Nov 30, 2017
Atlantis Abutment for MIS Implant
K172225 · NHA
Dentsply Sirona
Dental · 128d
Cleared Nov 30, 2017
TiLock Modular Spinal System
K172469 · NKB
Genesys Spine
Orthopedic · 107d
Cleared Nov 30, 2017
Disposable Linear Stapler, Disposable Linear Cutter
K172538 · GDW
Changzhou Kangdi Medical Stapler Co.,...
General & Plastic Surgery · 100d
Cleared Nov 30, 2017
HeRO Graft
K172637 · DSY
Merit Medical Systems, Inc.
Cardiovascular · 90d
Cleared Nov 30, 2017
Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid
K172767 · PHX
Zimmer, Inc.
Orthopedic · 78d
Cleared Nov 30, 2017
CryOmega Flexx
K172769 · GEH
Cryoconcepts LP
General & Plastic Surgery · 78d
Cleared Nov 30, 2017
Contact Lens Case, Model: A-1, B-1
K172925 · LRX
P L Overseas Limited
Ophthalmic · 66d
Cleared Nov 30, 2017
Destiknee™ Total Knee System
K172936 · JWH
Meril Healthcare Pvt. , Ltd.
Orthopedic · 65d