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Center for Drug Evaluation and Research (CDER)

946 FDA 510(k) clearances · Issuing office

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RecordFirmDate
Maison Blanche LLC - FDA Warning Letter (2023-09-14)2023-09-14
Gulf States International, Inc. - FDA Warning Letter (2023-09-12)2023-09-12
Walgreen Company - FDA Warning Letter (2023-09-12)2023-09-12
Boiron, Inc. - FDA Warning Letter (2023-09-11)2023-09-11
Natural Ophthalmics, Inc. - FDA Warning Letter (2023-09-11)2023-09-11
DR Vitamins, LLC dba DR Vitamin Solutions - FDA Warning Letter (2023-09-11)2023-09-11
CVS Health - FDA Warning Letter (2023-09-11)2023-09-11
TRP Company, Inc - FDA Warning Letter (2023-09-11)2023-09-11
OcluMed LLC - FDA Warning Letter (2023-09-11)2023-09-11
Walgreens Boots Alliance, Inc. - FDA Warning Letter (2023-09-11)2023-09-11
Similasan AG - FDA Warning Letter (2023-09-11)2023-09-11
Green Pharmaceutical Co. Ltd. - FDA Warning Letter (2023-08-23)2023-08-23
Molluscumaway LLC - FDA Warning Letter (2023-08-18)2023-08-18
MolluscumRx, Inc. - FDA Warning Letter (2023-08-18)2023-08-18
Nature’s Innovation, Inc. - FDA Warning Letter (2023-08-18)2023-08-18
Thrasio, LLC D/B/A ZymaDerm - FDA Warning Letter (2023-08-18)2023-08-18
Walmart, Inc - FDA Warning Letter (2023-08-18)2023-08-18
Amazon.com, Inc - FDA Warning Letter (2023-08-18)2023-08-18
K. Boeun Pharmaceutical Co., Ltd. - FDA Warning Letter (2023-08-14)2023-08-14
Cosmobeauti Laboratories & Manufacturing Inc. - FDA Warning Letter (2023-08-11)2023-08-11
CalmCo LLC previously named Ketomi LLC - FDA Warning Letter (2023-08-09)2023-08-09
Angela M. Stupi, M.D. - FDA Warning Letter (2023-08-08)2023-08-08
International Laboratories Corp. Ltd. - FDA Warning Letter (2023-08-08)2023-08-08
Cergomex Imports, LLC - FDA Warning Letter (2023-08-04)2023-08-04
GTP International Corp - FDA Warning Letter (2023-08-04)2023-08-04
Fancystage Unipessoal, LDA - FDA Warning Letter (2023-08-03)2023-08-03
Avaria Health & Beauty Corp. - FDA Warning Letter (2023-08-03)2023-08-03
KM Pharmaceutical Co. Ltd. - FDA Warning Letter (2023-08-03)2023-08-03
Tan Alize Kozmetik Ve Temizlik Urunleri - FDA Warning Letter (2023-08-03)2023-08-03
Sangleaf Pharm., Co. Ltd. - FDA Warning Letter (2023-08-03)2023-08-03
LCC Ltd. - FDA Warning Letter (2023-08-03)2023-08-03
Suhan Aerosol - FDA Warning Letter (2023-08-03)2023-08-03
Skyline Herbals Private Limited - FDA Warning Letter (2023-08-03)2023-08-03
Daxal Cosmetics Private Limited - FDA Warning Letter (2023-08-03)2023-08-03
Orchid Lifesciences - FDA Warning Letter (2023-08-03)2023-08-03
Intas Pharmaceuticals Limited - FDA Warning Letter (2023-07-28)2023-07-28
Baxter Healthcare Corporation - FDA Warning Letter (2023-07-25)2023-07-25
Centaur Pharmaceuticals Private Ltd. - FDA Warning Letter (2023-07-25)2023-07-25
Gadget Island, Inc. - FDA Warning Letter (2023-07-21)2023-07-21
Medgel Private Limited - FDA Warning Letter (2023-07-20)2023-07-20
Wise Women’s Choice - FDA Warning Letter (2023-07-20)2023-07-20
Sunshine Trading Company, Inc. dba Nova Tea and Nova Kratom - FDA Warning Letter (2023-07-03)2023-07-03
Lydia Co. Ltd. - FDA Warning Letter (2023-06-26)2023-06-26
Suprimo Imports - FDA Warning Letter (2023-06-22)2023-06-22
Chengdu KeCheng Fine Chemicals Co., Ltd. - FDA Warning Letter (2023-06-20)2023-06-20
Randy J. Epstein, M.D./Chicago Cornea Consultants, Ltd. - FDA Warning Letter (2023-06-14)2023-06-14
Warrior Labz SARMS - FDA Warning Letter (2023-06-12)2023-06-12
Centaur Pharmaceuticals Private Ltd. - FDA Warning Letter (2023-06-05)2023-06-05
Mobeen Mazhar, M.D. - FDA Warning Letter (2023-05-31)2023-05-31
citypharma.us - FDA Warning Letter (2023-05-22)2023-05-22
Champaklal Maganlal Homeo Pharmacy Private Limited - FDA Warning Letter (2023-05-18)2023-05-18
Tager Online, Inc. DBA Volt Candy; Volt Candy Wholesale Club - FDA Warning Letter (2023-04-27)2023-04-27
Nose Slap LLC - FDA Warning Letter (2023-04-24)2023-04-24
Sorcerz.com - FDA Warning Letter (2023-04-19)2023-04-19
Medolife Rx D/B/A MedoLife Corp., AELIA, Inc. and Quanta Inc. - FDA Warning Letter (2023-04-19)2023-04-19
Pharmaplast S.A.E. - FDA Warning Letter (2023-04-13)2023-04-13
Champaklal Maganlal Homeo Pharmacy Private Limited - FDA Warning Letter (2023-04-10)2023-04-10
Zermat International S.A. de C.V. - FDA Warning Letter (2023-04-06)2023-04-06
Tyrone L. McCall, M.D./Cornea Associates of Texas - FDA Warning Letter (2023-03-22)2023-03-22
www.ivermectin4covid.com - FDA Warning Letter (2023-03-16)2023-03-16
Robert J. Hayashi, M.D./Washington University School of Medicine, Department of Pediatrics - FDA Warning Letter (2023-03-14)2023-03-14
Procter & Gamble Manufactura S. de R.L. de C.V. - FDA Warning Letter (2023-03-14)2023-03-14
Maggie Jeffries, M.D. / Avanti Anesthesiology, LLC - FDA Warning Letter (2023-03-03)2023-03-03
ElectRx and Health Solutions, LLC - FDA Warning Letter (2023-03-02)2023-03-02
Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil - FDA Warning Letter (2023-02-13)2023-02-13
The Body Bean, LLC - FDA Warning Letter (2023-02-06)2023-02-06
Old Tiles Wallpaper, LLC DBA Old Tiles Decor - FDA Warning Letter (2023-01-30)2023-01-30
Monkeypox-treatment.com - FDA Warning Letter (2023-01-30)2023-01-30
Fei Fah Medical Manufacturing Pte. Ltd. - FDA Warning Letter (2023-01-30)2023-01-30
Buzzagogo, LLC - FDA Warning Letter (2023-01-18)2023-01-18
Larkin Community Hospital Institutional Review Board - FDA Warning Letter (2023-01-11)2023-01-11
HIS Enterprise Inc dba Adam’s Secret USA, LLC - FDA Warning Letter (2023-01-10)2023-01-10
Medical Mikes, Inc. - FDA Warning Letter (2023-01-10)2023-01-10
Purecraft LLC - FDA Warning Letter (2023-01-10)2023-01-10
Distributor RFR, LLC - FDA Warning Letter (2023-01-09)2023-01-09
pharmahealthonline.com - FDA Warning Letter (2023-01-06)2023-01-06
PharmaCanna - FDA Warning Letter (2023-01-05)2023-01-05
Superior Glove Works, Ltd. - FDA Warning Letter (2022-12-16)2022-12-16
Adarsh Daswani, M.D. - FDA Warning Letter (2022-12-14)2022-12-14
Nortec Quimica SA - FDA Warning Letter (2022-12-08)2022-12-08
Centrient Pharmaceuticals India Private Limited - FDA Warning Letter (2022-12-07)2022-12-07
Thriftmaster Texas, LLC. d/b/a ThriftMaster Global Holdings, Inc. and TM Global Biosciences, LLC - FDA Warning Letter (2022-12-05)2022-12-05
AG Hair Limited - FDA Warning Letter (2022-11-28)2022-11-28
Glenmark Pharmaceuticals Limited - FDA Warning Letter (2022-11-22)2022-11-22
David M. Lubeck, M.D./Arbor Centers for EyeCare - FDA Warning Letter (2022-11-18)2022-11-18
yourtramadol.com - FDA Warning Letter (2022-11-14)2022-11-14
goodimmuno.com - FDA Warning Letter (2022-11-14)2022-11-14
The Anthos Group, Inc. - FDA Warning Letter (2022-11-03)2022-11-03
Alternative Health Distribution LLC d/b/a CannaAid - FDA Warning Letter (2022-11-01)2022-11-01
Abraxis Bioscience LLC - FDA Warning Letter (2022-10-31)2022-10-31
Latin Foods Market - FDA Warning Letter (2022-10-28)2022-10-28
Walmart Inc. - FDA Warning Letter (2022-10-28)2022-10-28
Amazon.com, Inc. - FDA Warning Letter (2022-10-28)2022-10-28
Lakpura LLC - FDA Warning Letter (2022-10-24)2022-10-24
RiteAid Corporation - FDA Warning Letter (2022-10-19)2022-10-19
Unit Dose Services, LLC - FDA Warning Letter (2022-10-17)2022-10-17
Beijing Xinggu Lvsan Technology Co., Ltd. Formerly known as Beijing Lvsan Technology Co., Ltd. - FDA Warning Letter (2022-10-05)2022-10-05
Eksa Mills S.A. de C.V. - FDA Warning Letter (2022-10-05)2022-10-05
Bespoke Apothecary LLC - FDA Warning Letter (2022-09-28)2022-09-28
Lupin Limited - FDA Warning Letter (2022-09-27)2022-09-27
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