FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
14185–14208 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 2021
Dermoaroma Disposable Nitrile Examination Glove
K212716 · LZA
Chuzhou Harmony Gloves Medical...
General Hospital · 122d
Cleared Dec 27, 2021
Sterile Latex Surgical Gloves Powder Free
K212848 · KGO
Pentavest Holdings Sdn Bhd
General Hospital · 111d
Cleared Dec 27, 2021
Sonosite PX Ultrasound System
K213763 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 26d
Cleared Dec 25, 2021
Fixone hybrid knotless anchor
K203523 · MAI
Aju Pharm Co., Ltd.
Orthopedic · 389d
Cleared Dec 25, 2021
R3ACT Stabilization System
K211770 · HWC
Paragon 28, Inc.
Orthopedic · 200d
Cleared Dec 24, 2021
Skypro, SP02 Mask (3)
K202255 · FXX
Skypro Medical Supplies Company
General Hospital · 501d
Cleared Dec 24, 2021
Nitrile Examination Golves Powder Free
K212921 · LZA
Jiangsu Standard Health Co.,Ltd
General Hospital · 101d
Cleared Dec 24, 2021
CPL Surgical Face Mask
K213136 · FXX
Control Print Limited
General Hospital · 88d
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