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

49 results for "Plusglobal"
25–48 of 49
Search insights Median review: 267d Cleared: 100% Top manufacturer: Aju Pharm Co., Ltd. Lead specialty: General Hospital
Cleared May 06, 2020
CharmFil
K193496 · EBF
Dentkist, Inc.
Dental · 141d
Cleared Mar 11, 2020
Fixone Biocomposite Anchor
K192484 · MAI
Aju Pharm Co., Ltd.
Orthopedic · 183d
Cleared Mar 03, 2020
Fixone Biocomposite Small Anchor
K192032 · MAI
Aju Pharm Co., Ltd.
Orthopedic · 217d
Cleared Nov 04, 2019
Mei Ceramic Bracket
K190608 · NJM
Orthosun Co., Ltd.
Dental · 238d
Cleared May 17, 2019
SD Abutment
K173570 · NHA
Surgident Co., Ltd.
Dental · 543d
Cleared Jul 24, 2018
Autokeeper
K172095 · FMI
Medexel Co.,Ltd
General Hospital · 378d
Cleared Jun 21, 2018
Kopac Sterile Needle
K172483 · FMI
Poonglim Pharmatech, Inc.
General Hospital · 309d
Cleared Jun 18, 2018
IU Implant System
K172345 · DZE
Warantec Co., Ltd.
Dental · 320d
Cleared May 25, 2018
Automatic Tissue Processing Unit
K172717 · MUU
Bsl Co.
General & Plastic Surgery · 259d
Cleared May 24, 2018
GBR system
K170697 · JEY
Surgident
Dental · 443d
Cleared Dec 20, 2017
Pobling MIITY 2
K163550 · NFO
Habalan Med & Beauty Co.,Ltd
Neurology · 366d
Cleared Aug 24, 2017
Fixone Biocomposite Anchor
K171299 · MAI
Aju Pharm Co., Ltd.
Orthopedic · 113d
Cleared Mar 16, 2017
JOINIX CANNULAR SYSTEM
K162070 · HRX
Aju Pharm Co., Ltd.
Orthopedic · 232d
Cleared Nov 22, 2016
DW-1C
K160761 · NEW
Dongwon Medical Co., Ltd.
General & Plastic Surgery · 246d
Cleared Sep 21, 2016
CPL Insulin Pen Needle
K151090 · FMI
Cpl Co., Ltd.
General Hospital · 517d
Cleared Jul 12, 2016
SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE
K152803 · FMF
Sung Shim Medicare Co., Ltd.
General Hospital · 288d
Cleared Jul 11, 2016
JSM Insulin Pen Needle
K152166 · FMI
Jeesung Medical Co., Ltd.
General Hospital · 342d
Cleared Jun 28, 2016
Jeesung Safety Syringe and Single Use Needles
K152606 · MEG
Jeesung Medical Co., Ltd.
General Hospital · 291d
Cleared Jun 09, 2016
ATOVEN-Reusable Laser Fiber
K152667 · GEX
Diotech CO
General & Plastic Surgery · 266d
Cleared May 27, 2016
BIJOU Orthodontic Ceramic Bracket
K152167 · NJM
World Bio Tech Co., Ltd.
Dental · 297d
Cleared Mar 17, 2016
Endo Keeper
K152598 · OTJ
Nelis
General & Plastic Surgery · 188d
Cleared Mar 17, 2016
Sungshim Insulin Pen Needle
K152334 · FMI
Sung Shim Medicare Co., Ltd.
General Hospital · 211d
Cleared Mar 08, 2016
CharmFlex
K152766 · ELW
Dentkist, Inc.
Dental · 166d
Cleared Feb 02, 2016
Top Fine Pen Needle
K152410 · FMI
Medexel Co.,Ltd
General Hospital · 160d