FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
18697–18720 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 26, 2020
Adaptix Interbody System with Titan nanoLOCK Surface Technology
K201267 · MAX
Medtronic Sofamor Danek
Orthopedic · 106d
Cleared Aug 26, 2020
VenSure Balloon Device, VenSure Nav Balloon Device
K201472 · LRC
Fiagon GmbH
Ear, Nose, Throat · 84d
Cleared Aug 26, 2020
Motex Anti-Fog Surgical Face Mask
K201549 · FXX
Modern Healthcare Corp.
General Hospital · 78d
Cleared Aug 26, 2020
VersaOne Reusable Positioning Trocar System
K201805 · GCJ
Covidien
General & Plastic Surgery · 56d
Cleared Aug 26, 2020
Provicol QM Aesthetic
K201856 · EMA
Voco GmbH
Dental · 51d
Cleared Aug 26, 2020
Admiral ACP System
K202064 · KWQ
SeaSpine Orthopedics Corporation
Orthopedic · 30d
Cleared Aug 26, 2020
MindsEye Expandable Port
K202072 · GZT
Minnetronix Neuro, Inc.
Neurology · 30d
Cleared Aug 25, 2020
Injection Pen Needle
K192464 · FMI
Gangan Medical Technology Jiangsu...
General Hospital · 351d
Cleared Aug 25, 2020
Dental Handpiece
K192809 · EFA
Micro-Nx Co., Ltd.
Dental · 329d
Cleared Aug 25, 2020
Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes
K193338 · FLL
Shenzhen Med-Link Electronics Tech...
General Hospital · 267d
Cleared Aug 25, 2020
iMedium Single Step
K193522 · MQL
Kitazato Corporation
Obstetrics & Gynecology · 250d
Cleared Aug 25, 2020
VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe...
K200587 · ONN
Orthosensor, Inc.
Orthopedic · 172d
Cleared Aug 25, 2020
Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim...
K201772 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 57d
Cleared Aug 25, 2020
Cervical Plate System
K201979 · KWQ
Eminent Spine, LLC
Orthopedic · 40d
Cleared Aug 24, 2020
ST AIA-PACK BNP
K192380 · NBC
Fujirebio Diagnostics,Inc.
Chemistry · 360d
Cleared Aug 24, 2020
Intimate Rose Kegel Exercise System
K193364 · HIR
Plus EV Holdings Dba Intimate Rose
Obstetrics & Gynecology · 264d
Cleared Aug 24, 2020
MATRx plus
K200695 · MNR
Zephyr Sleep Technologies
Dental · 160d
Cleared Aug 24, 2020
Dynex Ring Fixation System, Diametrix Ring Fixation System
K202054 · KTT
Vilex, LLC
Orthopedic · 31d
Cleared Aug 22, 2020
Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control...
K201505 · OCC
Diasorin Molecular, LLC
Microbiology · 78d
Cleared Aug 21, 2020
BTL-785F
K193201 · GEI
Btl
General & Plastic Surgery · 275d
Cleared Aug 21, 2020
U-Cem Premium & MAZIC Cem
K193260 · EMA
Vericom Co., Ltd.
Dental · 269d
Cleared Aug 21, 2020
4K UHD Camera System
K200216 · HET
Scivita Medical Technology Co., Ltd.
Obstetrics & Gynecology · 206d
Cleared Aug 21, 2020
Brainsway Deep TMS System
K200957 · QMD
Brainsway , Ltd.
Neurology · 134d
Cleared Aug 21, 2020
NeuroBlate System
K201056 · GEX
Monteris Medical, Inc.
Neurology · 122d