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
36337–36360 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 2014
MERIT HYDROPHILIC GUIDEWIRE
K141295 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 211d
Cleared Dec 16, 2014
SOFIA (R) STREP A+ FIA
K141775 · GTY
Quidel Corporation
Microbiology · 168d
Cleared Dec 16, 2014
RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS
K142108 · MUJ
Brainlab AG
Radiology · 134d
Cleared Dec 16, 2014
Mini and Micro Fragments Reconstruction System-NEOFIX
K142419 · HRS
Neoortho Productos Orthopedicos S/A
Orthopedic · 110d
Cleared Dec 16, 2014
StitchKit
K142639 · GAW
Origami Surgical, LLC
General & Plastic Surgery · 90d
Cleared Dec 16, 2014
Sensor Medical Family of Vitrectomy Lenses and Products
K142715 · HJK
Sensor Medical Technology, LLC
Ophthalmic · 85d
Cleared Dec 16, 2014
Phlebo Press DVT 603
K142772 · JOW
Mego Afek AC , Ltd.
Cardiovascular · 82d
Cleared Dec 16, 2014
A1c iGear System
K142789 · LCP
Sakae Corporation
Chemistry · 81d
Cleared Dec 16, 2014
EXA
K142919 · LLZ
Viztek, LLC
Radiology · 69d
Cleared Dec 16, 2014
ArthroPlan Digital Templating Software
K142944 · LLZ
Arthromeda, Inc.
Radiology · 67d
Cleared Dec 16, 2014
Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for...
K143052 · LPL
Yung Sheng Optical Co., Ltd.
Ophthalmic · 54d
Cleared Dec 16, 2014
Elecsys Estradiol III Calcheck
K143284 · JJX
Roche Diagnostics
Chemistry · 29d
Cleared Dec 16, 2014
AIA-PACK C-Peptide Control Set
K143296 · JJX
Tosoh Bioscience, Inc.
Chemistry · 29d
Cleared Dec 15, 2014
ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE
K140593 · GCJ
Cook, Inc.
General & Plastic Surgery · 283d
Cleared Dec 15, 2014
WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER
K140667 · EZL
Well Lead Medical Co., Ltd.
Gastroenterology & Urology · 272d
Cleared Dec 15, 2014
NEXTGEN ALTIUS OCT SYSTEM
K140734 · KWP
Ebi, LLC
Orthopedic · 266d
Cleared Dec 15, 2014
ENDO-CORD
K141330 · FST
Enroxtech, Inc.
General & Plastic Surgery · 208d
Cleared Dec 15, 2014
INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM
K141513 · KCT
Summit Medical, Inc.
General Hospital · 189d
Cleared Dec 15, 2014
PLAC TEST FOR LP-PLA2 ACTIVITY
K141575 · NOE
Diadexus, Inc.
Chemistry · 186d
Cleared Dec 15, 2014
BBS REVOLUTION
K142329 · IYO
Dbmedx, Inc.
Radiology · 117d
Cleared CT Dec 15, 2014
Intact Advance and Intact Excision XL, Intact BLES
K142477 · KNW
Intact Medical Corporation
Gastroenterology & Urology · 103d
Cleared Dec 15, 2014
ProxiFuse Hammer Toe Device
K142490 · HWC
Cartiva, Inc.
Orthopedic · 102d
Cleared Dec 15, 2014
Stabilynx PEEK Suture Anchor
K142643 · MBI
D3 Dc, LLC /Stabilynx, Inc.
Orthopedic · 89d
Cleared Dec 15, 2014
The Panthera Anti-Snoring Device
K143244 · LRK
Panthera Dental, Inc.
Dental · 33d