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
20185–20208 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 2020
UCLA CCM Abutment
K192263 · NHA
Dio Corporation
Dental · 184d
Cleared Feb 21, 2020
Coolief Radiofrequency Generator (CRG) System
K192491 · GXD
Avanos Medical, Inc.
Neurology · 163d
Cleared Feb 21, 2020
Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60
K192600 · GEX
Quanta System Spa
General & Plastic Surgery · 154d
Cleared Feb 21, 2020
PatCom Single-Use Introducer
K192691 · FED
H&A Mui Enterprises, Inc.
Gastroenterology & Urology · 148d
Cleared Feb 21, 2020
Glenoid Baseplate with Screw
K192799 · PHX
Fx Shoulder USA, Inc.
Orthopedic · 144d
Cleared Feb 21, 2020
Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i
K192832 · JAK
Canon Medical Systems Corporation
Radiology · 142d
Cleared Feb 21, 2020
OASIS MRI System
K192851 · LNH
Hitachi Healthcare Americas
Radiology · 141d
Cleared Feb 21, 2020
TGS Guidewire and updated Scopis Software
K193118 · PGW
Stryker Ent
Ear, Nose, Throat · 101d
Cleared Feb 21, 2020
LightForce Orthodontic System (LFO System)
K200148 · NJM
Lightforce Orthodontics
Dental · 30d
Cleared Feb 21, 2020
3MP Monochrome Digital Mammography LCD Monitor MS-S300
K200161 · PGY
Jvckenwood Corporation
Radiology · 30d
Cleared Feb 21, 2020
SmoothSkin Pure
K200184 · OHT
Cyden Limited
General & Plastic Surgery · 28d
Cleared Feb 20, 2020
SDS2.2 dental implant
K190406 · DZE
Sds Swiss Dental Solutions AG
Dental · 364d
Cleared Feb 20, 2020
Flowart
K190806 · FPA
Asset Medikal Tasarim As.
General Hospital · 328d
Cleared Feb 20, 2020
X-MIND Trium
K191719 · MUH
De Gotzen S.R.L.
Radiology · 239d
Cleared Feb 20, 2020
Potenza
K192545 · GEI
Jeisys Medical Incorporated
General & Plastic Surgery · 157d
Cleared Feb 20, 2020
Gemini 810+980 Soft Tissue Laser
K192617 · GEX
Azena Medical, LLC
General & Plastic Surgery · 150d
Cleared Feb 20, 2020
ApneaTrak
K192624 · OLV
Cadwell Industries, Inc.
Neurology · 150d
Cleared Feb 20, 2020
Video Laparoscope, Video Processor, Light Source
K192918 · GCJ
Fujifilm Corporation
General & Plastic Surgery · 128d
Cleared Feb 20, 2020
Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter
K192922 · NQQ
Gentuity, LLC
Cardiovascular · 127d
Cleared Feb 20, 2020
HydroPICC (PICC-142)
K193015 · LJS
Access Vascular, Inc.
General Hospital · 114d
Cleared Feb 20, 2020
Exactech® Equinoxe® Reverse Shoulder Glenospheres
K193098 · PHX
Exactech, Inc.
Orthopedic · 105d
Cleared Feb 20, 2020
Largo PEEK Interbody System
K193255 · MAX
Flospine, LLC
Orthopedic · 86d
Cleared Feb 20, 2020
Tinnitus Sound Generator Module
K193303 · KLW
GN Hearing A/S
Ear, Nose, Throat · 83d
Cleared Feb 20, 2020
WIN Flexible Nail System
K193533 · JDS
Biomet, Inc.
Orthopedic · 62d