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

84 results for "LSI International, Inc."
49–72 of 84
Search insights Median review: 56d Cleared: 100% Top manufacturer: Healgen Scientific, LLC Lead specialty: Toxicology
Cleared Mar 17, 2023
Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug...
K223162 · LDJ
Healgen Scientific, LLC
Toxicology · 161d
Cleared Dec 27, 2022
IOB Warming Blankets
K221669 · DWJ
Iob Medical, Inc.
Cardiovascular · 201d
Cleared Aug 30, 2022
Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM)...
K221871 · NFT
Healstone Biotech, Inc.
Toxicology · 63d
Cleared Mar 16, 2022
Healgen Strep A Rapid Test Strip (Throat Swab)
K212623 · GTY
Healgen Scientific, LLC
Microbiology · 210d
Cleared Jan 31, 2022
Alltest Pregnancy Rapid Combo Test Cassette
K203272 · JHI
Hangzhou AllTest Biotech Co., Ltd.
Chemistry · 451d
Cleared Mar 30, 2021
ivi N3003 Surgical face Mask, ivi N6006 Surgical mask
K201896 · FXX
Iob Medical, Inc.
General Hospital · 265d
Cleared Jan 17, 2020
MAGLUMI 2000 HCG/ß-HCG
K192547 · DHA
Shenzhen New Industries Biomedical...
Chemistry · 122d
Cleared Oct 25, 2019
IOB Warming Blankets
K190221 · DWJ
Iob Medical, Inc.
Cardiovascular · 262d
Cleared Oct 11, 2019
BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20,...
K192515 · LDJ
Shenzhen Bioeasy Biotechnology Co., Ltd.
Toxicology · 28d
Cleared Sep 20, 2019
BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip
K192301 · NFW
Shenzhen Bioeasy Biotechnology Co., Ltd.
Toxicology · 28d
Cleared Aug 07, 2019
Accurate Multi Panel Drug Urine Test Cup
K191841 · NFT
Healstone Biotech, Inc.
Toxicology · 29d
Cleared Aug 01, 2019
MAGLUMI 2000 25-OH Vitamin D
K191499 · MRG
Shenzhen New Industries Biomedical...
Chemistry · 56d
Cleared Oct 04, 2018
MAGLUMI 2000 FT4
K182423 · CEC
Shenzhen New Industries Biomedical...
Chemistry · 28d
Cleared Aug 02, 2017
Healgen Multi-Drug Urine Test Cup
K163704 · JXM
Healgen Scientific, LLC
Toxicology · 216d
Cleared Jul 14, 2017
MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer
K162698 · JLW
Shenzhen New Industries Biomedical...
Chemistry · 290d
Cleared May 14, 2017
Wondfo One Step Fecal Occult Blood (FOB) Test
K162333 · KHE
Guangzhou Wondfo Biotech Co., Ltd.
Hematology · 265d
Cleared May 23, 2016
Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
K153597 · JXM
Healgen Scientific, LLC
Toxicology · 159d
Cleared Mar 18, 2016
CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test
K153741 · LDJ
Hangzhou Clongene Biotech Co., Ltd.
Toxicology · 81d
Cleared Nov 23, 2015
Wondfo Propoxyphene Urine Test
K152495 · JXN
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 83d
Cleared Nov 02, 2015
EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine...
K152643 · LDJ
Nantong Egens Biotech Co., Ltd.
Toxicology · 48d
Cleared Sep 09, 2015
Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine...
K152269 · DKZ
Healgen Scientific, LLC
Toxicology · 29d
Cleared Aug 18, 2015
Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen...
K151348 · LFG
Healgen Scientific, LLC
Toxicology · 90d
Cleared Aug 13, 2015
Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
K151642 · JXM
Healgen Scientific, LLC
Chemistry · 56d
Cleared Aug 07, 2015
Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine...
K150022 · LCX
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 213d