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
15289–15312 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 23, 2021
Contour® next GEN Blood Glucose Monitoring System
K193407 · NBW
Ascensia Diabetes Care
Chemistry · 745d
Cleared Dec 23, 2021
Sonomed IV, Sonomed V
K202788 · IMI
Carci Industria E Comercio DE...
Physical Medicine · 457d
Cleared Dec 23, 2021
NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar...
K203714 · MAX
Nu Vasive, Incorporated
Orthopedic · 367d
Cleared Dec 23, 2021
Curian Campy
K210976 · LQP
Meridian Bioscience, Inc.
Microbiology · 266d
Cleared Dec 23, 2021
Altech® Exhalation Valve (Single Limb and Dual Limb)
K210992 · CBP
Meditera Tibbi Malzeme San VE Tic AS
Anesthesiology · 265d
Cleared Dec 23, 2021
Integrity Implants Navigated Instruments
K212088 · OLO
Integrity Implants, Inc.
Orthopedic · 170d
Cleared Dec 23, 2021
NBR Synthetic Nitrile Examination Gloves
K212436 · LYZ
Shandong Langtai International Trade...
General Hospital · 141d
Cleared Dec 23, 2021
Twist Drills
K213208 · HBE
Biomet Microfixation
Neurology · 85d
Cleared Dec 23, 2021
Vy Spine™ VyWasher™ Buttress System
K213219 · KWQ
Vy Spine, LLC
Orthopedic · 85d
Cleared Dec 23, 2021
D²RS and D²RS 9090
K213479 · OWB
Stephanix
Radiology · 55d
Cleared Dec 23, 2021
SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE...
K213547 · HIS
Ttk Healthcare Limited
Obstetrics & Gynecology · 45d
Cleared Dec 23, 2021
dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for...
K213766 · MOS
Invivo Corporation
Radiology · 22d
Cleared Dec 22, 2021
BoneMRI
K202404 · QIH
Mriguidance B.V.
Radiology · 488d
Cleared Dec 22, 2021
SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay
K203564 · DJG
Immunalysis Corporation
Toxicology · 380d
Cleared Dec 22, 2021
SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay
K203647 · LAF
Immunalysis Corporation
Toxicology · 373d
Cleared Dec 22, 2021
Unico High Performance Surgical Mask, Unico High Performance Surgical Mask...
K210147 · FXX
Unicoglobal, Inc.
General Hospital · 335d
Cleared Dec 22, 2021
Pulse Oximeter
K210305 · DQA
Dongguan Lingxin Technologies Co., Ltd.
Anesthesiology · 322d
Cleared Dec 22, 2021
Neocis Guidance System (NGS) with Yomi Plan v2.0.1
K210711 · PLV
Neocis, Inc.
Dental · 287d
Cleared Dec 22, 2021
BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle
K210978 · BSP
Becton, Dickinson and Company
Anesthesiology · 265d
Cleared Dec 22, 2021
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with...
K211022 · LZA
Central Medicare Sdn Bhd
General Hospital · 261d
Cleared Dec 22, 2021
Ultrast Gel
K211691 · MUI
Ultrast, Inc.
Radiology · 203d
Cleared Dec 22, 2021
Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310...
K212285 · NUH
Oriental Inspiration Limited
Neurology · 154d
Cleared Dec 22, 2021
EyeBOX (Model EBX-4)
K212310 · QEA
Oculogica, Inc.
Neurology · 152d
Cleared Dec 22, 2021
StealthStation S8 Cranial v2.0
K212397 · HAW
Medtronic Navigation
Neurology · 142d