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
26449–26472 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 2018
Incontinence Treatment Device, Model LT2061
K171430 · KPI
Shenzhen Dongdixin Technology Co., Ltd.
Gastroenterology & Urology · 304d
Cleared Mar 15, 2018
TDM Plate and Screw System
K171808 · HRS
Tdm Co., Ltd.
Orthopedic · 269d
Cleared Mar 15, 2018
Mega Plus Spine System
K173180 · NKB
Bk Meditech, Co., Ltd.
Orthopedic · 167d
Cleared Mar 15, 2018
TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System
K173811 · HSB
In2bones Sas
Orthopedic · 90d
Cleared Mar 15, 2018
Tissue of Origin Test Kit-FFPE
K173839 · OIW
Cancer Genetics, Inc.
Pathology · 87d
Cleared Mar 15, 2018
X-spine Cortical Bone Screw System
K180153 · NKB
X-Spine Systems, Inc.
Orthopedic · 55d
Cleared Mar 15, 2018
NuVasive® VuePoint® II OCT System
K180198 · NKG
Nu Vasive, Incorporated
Orthopedic · 50d
Cleared Mar 15, 2018
ELEMENT-TL
K180224 · GEX
Elemenic Co., Ltd.
General & Plastic Surgery · 48d
Cleared Mar 15, 2018
Polaris Spinal Growth System
K180227 · PGM
Zimmer Biomet Spine, Inc.
Orthopedic · 48d
Cleared Mar 15, 2018
Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL
K180330 · JWY
Liofilchem S. R. L.
Microbiology · 37d
Cleared Mar 15, 2018
AIRO Computed Tomography (CT) X-ray System
K180393 · JAK
Mobius Imaging, LLC
Radiology · 30d
Cleared Mar 15, 2018
miraDry System
K180396 · NEY
Miramar Labs, Inc.
General & Plastic Surgery · 30d
Cleared Mar 15, 2018
FUJIFILM Endoscope Models EC-600HL and EC-600LS
K180405 · FDF
Fujifilm Corporation
Gastroenterology & Urology · 29d
Cleared Mar 15, 2018
Ellipse Ydun
K180406 · GEX
Ellipse A/S
General & Plastic Surgery · 29d
Cleared Mar 15, 2018
Empower H65
K180423 · GEX
Quanta System Spa
General & Plastic Surgery · 27d
Cleared Mar 15, 2018
INSPIRE 6M Hollow Fiber Oxygenator
K180448 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 30d
Cleared Mar 14, 2018
MR Wireless Gating System, Model WGS-100
K171778 · LNH
Ivy Biomedical Systems, Inc.
Radiology · 272d
Cleared Mar 14, 2018
star RF Electrode, VIVA RF Electrode
K172012 · GEI
Starmed Co., Ltd.
General & Plastic Surgery · 254d
Cleared Mar 14, 2018
Dynarex Three-Way Stopcock
K172266 · FMG
Dynarex Corporation
General Hospital · 230d
Cleared Mar 14, 2018
Cardiovascular Analzyer
K172431 · DSB
Physiowave, Inc.
Cardiovascular · 215d
Cleared Mar 14, 2018
Infrared Thermometer
K172795 · FLL
Shenzhen Jumper Medical Equipment...
General Hospital · 180d
Cleared Mar 14, 2018
Athena GTX Device Management Suite (ADMS) Software
K173203 · MSX
Athena Gtx
Cardiovascular · 163d
Cleared Mar 14, 2018
AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared
K173794 · LZO
Medacta International S.A.
Orthopedic · 90d
Cleared Mar 14, 2018
Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
K173798 · PGI
Diasorin Molecular, LLC
Microbiology · 90d