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Center for Drug Evaluation and Research (CDER)

946 FDA 510(k) clearances · Issuing office

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RecordFirmDate
TKTX Numbing Cream USA - FDA Warning Letter (2025-02-25)2025-02-25
Aspen Pharmacare Holdings Limited - FDA Warning Letter (2025-02-24)2025-02-24
Zenzi Pharmaceutical Industries Pvt. Ltd. - FDA Warning Letter (2025-02-13)2025-02-13
Chem-Tech, Ltd. - FDA Warning Letter (2025-02-11)2025-02-11
Marshalls Traditional Healthcare CC - FDA Warning Letter (2025-02-10)2025-02-10
ABR Laboratory LLC - FDA Warning Letter (2025-02-10)2025-02-10
Tyche Industries Ltd - FDA Warning Letter (2025-02-06)2025-02-06
Jagsonpal Pharmaceuticals Limited - FDA Warning Letter (2025-02-05)2025-02-05
Chengdu Innovation Pharmaceutical Co., Ltd. - FDA Warning Letter (2025-02-05)2025-02-05
Wuhu Nuowei Chemistry Co., Ltd. - FDA Warning Letter (2025-02-04)2025-02-04
ISOThrive, Inc. - FDA Warning Letter (2025-02-04)2025-02-04
Strukmyer LLC dba Strukmyer Medical - FDA Warning Letter (2025-01-30)2025-01-30
AmWiner & Raphe Holdings, LLC dba rapheGenerics Corp - FDA Warning Letter (2025-01-29)2025-01-29
Rite-Kem Incorporated - FDA Warning Letter (2025-01-28)2025-01-28
Shantou Kangjie Daily Chemical Industry Co., Ltd - FDA Warning Letter (2025-01-28)2025-01-28
Imperial Palace Commodity -Dongguan- Co., Ltd. - FDA Warning Letter (2025-01-27)2025-01-27
Center for Instrumental Analysis of China Pharmaceutical University - FDA Warning Letter (2025-01-23)2025-01-23
Nubratori, Inc. dba Nubratori Rx - FDA Warning Letter (2025-01-22)2025-01-22
Kardesler Ucan Yaglar Sanayi Anonim Sirketi - FDA Warning Letter (2025-01-21)2025-01-21
Global Calcium Pvt. Limited - FDA Warning Letter (2025-01-16)2025-01-16
Mihon Corp. d/b/a VitalityVita and Boulla, LLC - FDA Warning Letter (2025-01-16)2025-01-16
Sanofi - FDA Warning Letter (2025-01-15)2025-01-15
www.weightcrunchshop.com - FDA Warning Letter (2025-01-13)2025-01-13
Atlanta Supersource, Inc. - FDA Warning Letter (2025-01-08)2025-01-08
Fagron Compounding Services, LLC dba Fagron Sterile Service - FDA Warning Letter (2024-12-19)2024-12-19
Viatris, Inc. - FDA Warning Letter (2024-12-19)2024-12-19
Bhargava Phytolab Private Limited - FDA Warning Letter (2024-12-18)2024-12-18
Sombra Cosmetics, Inc. - FDA Warning Letter (2024-12-18)2024-12-18
Right Value Drug Stores, LLC dba Carie Boyd Pharmaceuticals - FDA Warning Letter (2024-12-17)2024-12-17
Akron Formulations India Private Limited - FDA Warning Letter (2024-12-17)2024-12-17
Brands International Corporation - FDA Warning Letter (2024-12-17)2024-12-17
Indoco Remedies Limited - FDA Warning Letter (2024-12-16)2024-12-16
Veronvy - FDA Warning Letter (2024-12-10)2024-12-10
Prime Vitality, Inc. dba Prime Peptides - FDA Warning Letter (2024-12-10)2024-12-10
Swisschems - FDA Warning Letter (2024-12-10)2024-12-10
Xcel Research LLC - FDA Warning Letter (2024-12-10)2024-12-10
Summit Research Peptides - FDA Warning Letter (2024-12-10)2024-12-10
Micro Orgo Chem - FDA Warning Letter (2024-12-03)2024-12-03
Han C. Phan, M.D. - FDA Warning Letter (2024-12-03)2024-12-03
Applied Therapeutics, Inc. - FDA Warning Letter (2024-12-03)2024-12-03
Dr. Brite, LLC - FDA Warning Letter (2024-11-21)2024-11-21
LCC Ltd. - FDA Warning Letter (2024-11-21)2024-11-21
Catwalk Cosmetic Laboratories Pty Ltd. - FDA Warning Letter (2024-11-21)2024-11-21
Eurosirel S.P.A - FDA Warning Letter (2024-11-20)2024-11-20
Hangzhou Huiji Biotechnology Co., Ltd. - FDA Warning Letter (2024-11-18)2024-11-18
Centura Pharmaceuticals Inc - FDA Warning Letter (2024-11-15)2024-11-15
Guangzhou Four E’s Scientific Co., Ltd. - FDA Warning Letter (2024-11-13)2024-11-13
Zhejiang Uniquality Nursing Products Technology Co., Ltd. dba ZheJiang YouQuan Care Products Technology Co., Ltd. - FDA Warning Letter (2024-11-12)2024-11-12
Originitalia SRL - FDA Warning Letter (2024-11-07)2024-11-07
Zhejiang Qimei Cosmetics Co., Ltd. - FDA Warning Letter (2024-11-07)2024-11-07
Unexo Lifesciences, Private Limited - FDA Warning Letter (2024-11-06)2024-11-06
Richard W. Foltin, Ph.D. - FDA Warning Letter (2024-11-06)2024-11-06
Colgate-Palmolive/Tom's of Maine, Inc. - FDA Warning Letter (2024-11-05)2024-11-05
Multaler et Cie SAS - FDA Warning Letter (2024-11-05)2024-11-05
Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd. - FDA Warning Letter (2024-10-30)2024-10-30
Armstrong County Memorial Hospital - FDA Warning Letter (2024-10-29)2024-10-29
Fancy Drops Beauty LLC - FDA Warning Letter (2024-10-24)2024-10-24
MedOffice Saglik Endustri Anonim Sirketi - FDA Warning Letter (2024-10-23)2024-10-23
Choice All Natural, Inc. dba Om Botanical - FDA Warning Letter (2024-10-21)2024-10-21
Diora Kimya Sanayi ve Ticaret Limited Sirketi - FDA Warning Letter (2024-10-17)2024-10-17
Analytical Food Laboratories, Inc. - FDA Warning Letter (2024-10-10)2024-10-10
Soliteint Kozmetikai KFT - FDA Warning Letter (2024-10-10)2024-10-10
Hangzhou Glamcos Biotech Co., Ltd. - FDA Warning Letter (2024-10-07)2024-10-07
Omni Lens Pvt. Ltd. - FDA Warning Letter (2024-10-02)2024-10-02
Mexicanrxpharm.com - FDA Warning Letter (2024-09-30)2024-09-30
Louisiana State University Health Science Center IRB - FDA Warning Letter (2024-09-27)2024-09-27
Makra Kozmetika D.O.O. - FDA Warning Letter (2024-09-26)2024-09-26
Supercore Products Group, Inc. - FDA Warning Letter (2024-09-26)2024-09-26
Outin Futures Corp. - FDA Warning Letter (2024-09-25)2024-09-25
MMC Healthcare Ltd. - FDA Warning Letter (2024-09-24)2024-09-24
Azurity Pharmaceuticals, Inc. - FDA Warning Letter (2024-09-20)2024-09-20
Nomida.biz - FDA Warning Letter (2024-09-12)2024-09-12
Quality CDMO, Inc. - FDA Warning Letter (2024-09-11)2024-09-11
Aromas Para El Alma S.A. - FDA Warning Letter (2024-09-10)2024-09-10
EnviroServe Chemicals & Cleaners Ltd. - FDA Warning Letter (2024-09-09)2024-09-09
Avaria Health & Beauty Corp. - FDA Warning Letter (2024-09-03)2024-09-03
Root Bioscience Brands, LLC dba Naternal - FDA Warning Letter (2024-08-30)2024-08-30
Zydus Lifesciences Limited - FDA Warning Letter (2024-08-29)2024-08-29
Orean Personal Care Ltd. - FDA Warning Letter (2024-08-29)2024-08-29
MexHealth LLC d/b/a Al Natural E-Shop - FDA Warning Letter (2024-08-27)2024-08-27
SoloVital - FDA Warning Letter (2024-08-27)2024-08-27
Everymarket Inc. - FDA Warning Letter (2024-08-27)2024-08-27
Julio R. Flamini, M.D./Clinical Integrative Research Center of Atlanta - FDA Warning Letter (2024-08-20)2024-08-20
AnuMed International, LLC - FDA Warning Letter (2024-08-20)2024-08-20
Media Networks Sydney Pty Limited - FDA Warning Letter (2024-08-15)2024-08-15
Eugia Pharma Specialities Limited - FDA Warning Letter (2024-08-15)2024-08-15
Intercos Europe S.p.A - FDA Warning Letter (2024-08-15)2024-08-15
Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. - FDA Warning Letter (2024-08-01)2024-08-01
Walmart, Inc. - FDA Warning Letter (2024-07-25)2024-07-25
ISIS.GOLD - FDA Warning Letter (2024-07-25)2024-07-25
Skin Beauty Solutions - FDA Warning Letter (2024-07-25)2024-07-25
Repare Skincare - FDA Warning Letter (2024-07-25)2024-07-25
Matte Beauty - FDA Warning Letter (2024-07-25)2024-07-25
Amazon.com, Inc. - FDA Warning Letter (2024-07-25)2024-07-25
V10Suppliers.com - FDA Warning Letter (2024-07-22)2024-07-22
Velocity Pharma LLC - FDA Warning Letter (2024-07-17)2024-07-17
Nowrez & Ismail Shukri Company - FDA Warning Letter (2024-07-11)2024-07-11
Brassica Pharma Pvt. Ltd. - FDA Warning Letter (2024-07-11)2024-07-11
Jiangsu Hengrui Pharmaceuticals Co., Ltd. - FDA Warning Letter (2024-07-11)2024-07-11
Cholrem Pty Ltd dba Cholrem and Cholrem Pharmaceuticals - FDA Warning Letter (2024-07-09)2024-07-09
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