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Center for Drug Evaluation and Research (CDER)

946 FDA 510(k) clearances · Issuing office

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RecordFirmDate
Kabana Skin Care LLC - FDA Warning Letter (2025-07-18)2025-07-18
www.mysteroidsmarket.com - FDA Warning Letter (2025-07-17)2025-07-17
www.plakini-pharma.com - FDA Warning Letter (2025-07-16)2025-07-16
www.d-pharmacy.com - FDA Warning Letter (2025-07-16)2025-07-16
www.portmeds.com - FDA Warning Letter (2025-07-16)2025-07-16
Oasis Medical, Inc. - FDA Warning Letter (2025-07-15)2025-07-15
Glenmark Pharmaceuticals Limited - FDA Warning Letter (2025-07-11)2025-07-11
Gussyup LLC dba Private Label Grooming - FDA Warning Letter (2025-07-09)2025-07-09
Medical Chemical Corporation - FDA Warning Letter (2025-07-09)2025-07-09
Scope Health Inc - FDA Warning Letter (2025-07-09)2025-07-09
Revitalize Energy, Inc. - FDA Warning Letter (2025-07-09)2025-07-09
Thea Pharma, Inc. - FDA Warning Letter (2025-07-09)2025-07-09
EyeTech One, LLC - FDA Warning Letter (2025-07-09)2025-07-09
Covalent Medical - FDA Warning Letter (2025-07-09)2025-07-09
Daewoo Pharmaceutical Co., Ltd. - FDA Warning Letter (2025-07-02)2025-07-02
Exela Pharma Sciences, LLC - FDA Warning Letter (2025-07-02)2025-07-02
Libby Laboratories, Inc. - FDA Warning Letter (2025-06-27)2025-06-27
Mark J. Savant, M.D - FDA Warning Letter (2025-06-26)2025-06-26
Nature’s Fusions LLC - FDA Warning Letter (2025-06-25)2025-06-25
7Tabz Retail, LLC - FDA Warning Letter (2025-06-25)2025-06-25
Hydroxie, LLC - FDA Warning Letter (2025-06-25)2025-06-25
Xtreme Tools International, Inc. - FDA Warning Letter (2025-06-25)2025-06-25
Dynamic Blending Specialists, Inc. - FDA Warning Letter (2025-06-18)2025-06-18
Peter Michael, M.D. - FDA Warning Letter (2025-06-18)2025-06-18
Pushclean Technology Plastik Sanayi Ve Ticaret Ltd. Sirketi - FDA Warning Letter (2025-06-16)2025-06-16
www.soma4ever.com - FDA Warning Letter (2025-06-13)2025-06-13
www.buynetmeds.com - FDA Warning Letter (2025-06-12)2025-06-12
Healwell Homeo Private Limited - FDA Warning Letter (2025-06-12)2025-06-12
Kenil Healthcare Private Limited - FDA Warning Letter (2025-06-12)2025-06-12
www.buyprosoma.com - FDA Warning Letter (2025-06-10)2025-06-10
Horizon Tool Inc. - FDA Warning Letter (2025-06-06)2025-06-06
Sterling Distributors - FDA Warning Letter (2025-06-05)2025-06-05
www.bigpharmausa.com - FDA Warning Letter (2025-06-04)2025-06-04
Bio Wellness 444 LLC - FDA Warning Letter (2025-05-30)2025-05-30
Laboratoire Druide Inc. - FDA Warning Letter (2025-05-29)2025-05-29
Amish Origins Management, LLC - FDA Warning Letter (2025-05-29)2025-05-29
CTK OTC Laboratories LLC formerly FMK LABS, Inc. - FDA Warning Letter (2025-05-19)2025-05-19
Evi Labs LLC - FDA Warning Letter (2025-05-14)2025-05-14
Zhejiang Easyclean Daily Chemical Co., Ltd - FDA Warning Letter (2025-05-14)2025-05-14
AACE Pharmaceuticals, Inc. - FDA Warning Letter (2025-05-13)2025-05-13
Product Society LLC - FDA Warning Letter (2025-05-08)2025-05-08
Excelvision Fareva - FDA Warning Letter (2025-05-07)2025-05-07
Shenzhen Hengkaifeng Commerce and Trade Co., Ltd - FDA Warning Letter (2025-05-06)2025-05-06
Staska Pharmaceuticals, Inc. - FDA Warning Letter (2025-05-05)2025-05-05
www.peacefulmeds.com - FDA Warning Letter (2025-05-05)2025-05-05
www.buycodeine.us - FDA Warning Letter (2025-05-05)2025-05-05
American Behavioral Research Institute, LLC - FDA Warning Letter (2025-04-30)2025-04-30
Rechon Life Science AB - FDA Warning Letter (2025-04-30)2025-04-30
Ningbo Riway Industrial Co., Ltd. - FDA Warning Letter (2025-04-30)2025-04-30
Nana Barseghian, M.D. - FDA Warning Letter (2025-04-28)2025-04-28
www.24hreup.biz - FDA Warning Letter (2025-04-23)2025-04-23
OSRX, Inc. - FDA Warning Letter (2025-04-23)2025-04-23
Amazon.com, Inc. - FDA Warning Letter (2025-04-17)2025-04-17
Mentha & Allied Products Private Ltd. - FDA Warning Letter (2025-04-16)2025-04-16
Shantou S.E.Z. Baojie Industry Co., Ltd. - FDA Warning Letter (2025-04-15)2025-04-15
Cosco International, Inc. - FDA Warning Letter (2025-04-14)2025-04-14
Dyno Manufacturing, Inc. - FDA Warning Letter (2025-04-09)2025-04-09
BEO Pharma Inc. dba BEO Pharmaceuticals Inc. - FDA Warning Letter (2025-04-09)2025-04-09
Tailstorm Health Inc. dba Medivant Health - FDA Warning Letter (2025-04-08)2025-04-08
PMS4PMS, LLC - FDA Warning Letter (2025-04-07)2025-04-07
Wuxi Medical Instrument Factory Co., Ltd. - FDA Warning Letter (2025-04-04)2025-04-04
Taizhou Jingshang Cosmetics Technology Co., Ltd. - FDA Warning Letter (2025-04-02)2025-04-02
Empower Clinic Services, LLC dba Empower Pharmacy - FDA Warning Letter (2025-04-02)2025-04-02
Empower Clinic Services, LLC dba Empower Pharma - FDA Warning Letter (2025-04-02)2025-04-02
NWL Netherlands Services B.V. - FDA Warning Letter (2025-04-01)2025-04-01
Prodose, Inc. formerly known as Spirit Pharmaceuticals LLC - FDA Warning Letter (2025-03-28)2025-03-28
Yiling Pharmaceutical Ltd. - FDA Warning Letter (2025-03-27)2025-03-27
www.thesafepills.org - FDA Warning Letter (2025-03-27)2025-03-27
Naturista Store LLC - FDA Warning Letter (2025-03-26)2025-03-26
BioAsia Worldwide Sdn Bhd - FDA Warning Letter (2025-03-25)2025-03-25
Americo F. Padilla, M.D. - FDA Warning Letter (2025-03-25)2025-03-25
Huangshi Hygienic Material Medicine Co., Ltd. - FDA Warning Letter (2025-03-24)2025-03-24
BPI Labs, LLC - FDA Warning Letter (2025-03-20)2025-03-20
Advanced Pharmaceutical Technology - FDA Warning Letter (2025-03-14)2025-03-14
Yangzhou Sion Commodity Co., Ltd. - FDA Warning Letter (2025-03-12)2025-03-12
Neva Global Grup Sanayi Ic Ve Dis Ticaret Anonim Sirketi - FDA Warning Letter (2025-03-12)2025-03-12
Kabana Skin Care - FDA Warning Letter (2025-03-12)2025-03-12
Waxhead Sun Defense Company - FDA Warning Letter (2025-03-12)2025-03-12
CoLabs Intl. Corp - FDA Warning Letter (2025-03-12)2025-03-12
International Laboratories Corp - FDA Warning Letter (2025-03-10)2025-03-10
Pico IV Inc. - FDA Warning Letter (2025-03-06)2025-03-06
Macsen Drugs - FDA Warning Letter (2025-03-05)2025-03-05
Annovex Pharma, Inc. - FDA Warning Letter (2025-03-05)2025-03-05
Aspen Biopharma Labs Private Limited - FDA Warning Letter (2025-03-05)2025-03-05
Mehran Michael Bahrami, M.D. - FDA Warning Letter (2025-03-05)2025-03-05
C & A Naturistics - FDA Warning Letter (2025-03-04)2025-03-04
ProRx, LLC - FDA Warning Letter (2025-03-04)2025-03-04
Filler Lux dba Filler Lux USA - FDA Warning Letter (2025-03-03)2025-03-03
Fox Pharma LLC - FDA Warning Letter (2025-03-03)2025-03-03
Hyaluron Pen Store, LLC dba Glow Nest Beauty - FDA Warning Letter (2025-03-03)2025-03-03
Julian Naya Beauty LLC - FDA Warning Letter (2025-03-03)2025-03-03
Vivid-Scientific LLC - FDA Warning Letter (2025-03-03)2025-03-03
Amazon.com, Inc. - FDA Warning Letter (2025-03-03)2025-03-03
Shree Jaya Laboratories PVT. LTD. - FDA Warning Letter (2025-02-28)2025-02-28
USApeptide.com - FDA Warning Letter (2025-02-26)2025-02-26
Granules India Limited - FDA Warning Letter (2025-02-26)2025-02-26
Linghai ZhanWang Biotechnology Co., Ltd - FDA Warning Letter (2025-02-25)2025-02-25
TKTX USA - FDA Warning Letter (2025-02-25)2025-02-25
TKTX Numb Store - FDA Warning Letter (2025-02-25)2025-02-25
TKTX Store - FDA Warning Letter (2025-02-25)2025-02-25
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