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Center for Drug Evaluation and Research (CDER)

946 FDA 510(k) clearances · Issuing office

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RecordFirmDate
Apollo Care, LLC - FDA Warning Letter (2026-02-02)2026-02-02
Bertrand P. Cole, D.O. - FDA Warning Letter (2026-02-02)2026-02-02
Mark S. Dacey, M.D. - FDA Warning Letter (2026-02-02)2026-02-02
Cohance Lifesciences Limited - FDA Warning Letter (2026-01-30)2026-01-30
HTO Nevada, Inc. dba Kirkman - FDA Warning Letter (2026-01-27)2026-01-27
Signature Formulations, LLC - FDA Warning Letter (2026-01-21)2026-01-21
GenoGenix LLC - FDA Warning Letter (2026-01-20)2026-01-20
Boothwyn Pharmacy, LLC - FDA Warning Letter (2026-01-16)2026-01-16
Fulijaya Manufacturing SDN. BHD. - FDA Warning Letter (2026-01-14)2026-01-14
Center For Immunology Science, LLC - FDA Warning Letter (2026-01-13)2026-01-13
Prodrome Sciences USA, LLC - FDA Warning Letter (2026-01-08)2026-01-08
Winder Laboratories, LLC - FDA Warning Letter (2026-01-07)2026-01-07
Absolutely Natural - FDA Warning Letter (2025-12-30)2025-12-30
Chemspec Chemicals Private Limited - FDA Warning Letter (2025-12-23)2025-12-23
Tower Laboratories Ltd. - FDA Warning Letter (2025-12-23)2025-12-23
Purushothaman Damodara Kumaran, M.D. / Senthil Specialty Hospital - FDA Warning Letter (2025-12-22)2025-12-22
LiquidCapsule Manufacturing, LLC - FDA Warning Letter (2025-12-19)2025-12-19
Agebox Inc. - FDA Warning Letter (2025-12-19)2025-12-19
Unipack LLC - FDA Warning Letter (2025-12-19)2025-12-19
Private Label Skin Care, Inc. - FDA Warning Letter (2025-12-18)2025-12-18
Guangdong Renhe Guozhuang Biotechnology Co., Ltd. - FDA Warning Letter (2025-12-16)2025-12-16
Integrity Partners Group - FDA Warning Letter (2025-12-15)2025-12-15
MedisourceRx - FDA Warning Letter (2025-12-12)2025-12-12
Atomix LLC - FDA Warning Letter (2025-12-12)2025-12-12
Prime Sports Nutrition - FDA Warning Letter (2025-12-12)2025-12-12
Pinnacle Professional Research dba Pinnacle Peptides - FDA Warning Letter (2025-12-12)2025-12-12
Dynamic Health Group dba SARMS AMERICA - FDA Warning Letter (2025-12-12)2025-12-12
TITAN SARMS LLC - FDA Warning Letter (2025-12-12)2025-12-12
Maria A. Carballosa, M.D. - FDA Warning Letter (2025-12-12)2025-12-12
Musclepower Enterprise Ltd. dba MONSTER KING and GE LABS - FDA Warning Letter (2025-12-12)2025-12-12
Devalingam Mahalingam, M.D., Ph.D. - FDA Warning Letter (2025-12-11)2025-12-11
Medinatura New Mexico, Inc. - FDA Warning Letter (2025-12-10)2025-12-10
Sklar Personal Care Inc. - FDA Warning Letter (2025-12-09)2025-12-09
Darmerica, LLC - FDA Warning Letter (2025-12-08)2025-12-08
3D Imaging Drug Design and Development LLC - FDA Warning Letter (2025-12-04)2025-12-04
Apothecary Pharma, LLC - FDA Warning Letter (2025-12-01)2025-12-01
CDL Services, Inc. DBA Technichem - FDA Warning Letter (2025-11-24)2025-11-24
VarunKart Group LLC dba Organic Wellnesses - FDA Warning Letter (2025-11-17)2025-11-17
Distacart Inc. - FDA Warning Letter (2025-11-17)2025-11-17
Swift Digital Group LLC dba Swadesii - FDA Warning Letter (2025-11-17)2025-11-17
Handelnine Global, LLC dba Navafresh - FDA Warning Letter (2025-11-17)2025-11-17
Mahita LLC dba PushMyCart - FDA Warning Letter (2025-11-17)2025-11-17
123Herbals - FDA Warning Letter (2025-11-13)2025-11-13
Cdymax India Pharma Private Limited - FDA Warning Letter (2025-11-13)2025-11-13
Shoplet - FDA Warning Letter (2025-11-13)2025-11-13
Save Rite Medical - FDA Warning Letter (2025-11-13)2025-11-13
Medical Mega - FDA Warning Letter (2025-11-13)2025-11-13
Seema International - FDA Warning Letter (2025-11-13)2025-11-13
DeVere Manufacturing Inc. - FDA Warning Letter (2025-11-12)2025-11-12
Rhyz Analytical Labs - FDA Warning Letter (2025-11-12)2025-11-12
Sinsin Pharmaceutical Co., Ltd. - FDA Warning Letter (2025-11-12)2025-11-12
Verdure Sciences, Inc. - FDA Warning Letter (2025-11-10)2025-11-10
Wells Pharma of Houston, LLC - FDA Warning Letter (2025-11-07)2025-11-07
Siddha Flower Essences, LLC., dba Siddha Remedies - FDA Warning Letter (2025-11-04)2025-11-04
Miers Laboratories, Ltd - FDA Warning Letter (2025-11-03)2025-11-03
Cosmenic - FDA Warning Letter (2025-11-03)2025-11-03
Dermacare dba Filler Outlet - FDA Warning Letter (2025-11-03)2025-11-03
Maypharm - FDA Warning Letter (2025-11-03)2025-11-03
Estaderma - FDA Warning Letter (2025-11-03)2025-11-03
Korean Aesthetic dba Korean Fillers - FDA Warning Letter (2025-11-03)2025-11-03
CelestaPro - FDA Warning Letter (2025-11-03)2025-11-03
AceCosm - FDA Warning Letter (2025-11-03)2025-11-03
Dermax Co., Ltd - FDA Warning Letter (2025-11-03)2025-11-03
Glow Nest Beauty - FDA Warning Letter (2025-11-03)2025-11-03
Aesthetic Essentials Limited - FDA Warning Letter (2025-11-03)2025-11-03
Elle Pharm - FDA Warning Letter (2025-11-03)2025-11-03
COSMO KOREA - FDA Warning Letter (2025-11-03)2025-11-03
Glam Derma - FDA Warning Letter (2025-11-03)2025-11-03
Meamo - FDA Warning Letter (2025-11-03)2025-11-03
MJS Medicals - FDA Warning Letter (2025-11-03)2025-11-03
Derma Solution - FDA Warning Letter (2025-11-03)2025-11-03
Glowface - FDA Warning Letter (2025-11-03)2025-11-03
Apotex Inc. - FDA Warning Letter (2025-10-31)2025-10-31
Owen Biosciences, Inc. - FDA Warning Letter (2025-10-30)2025-10-30
World Perfumes Inc. - FDA Warning Letter (2025-10-29)2025-10-29
DermaRite Industries, LLC - FDA Warning Letter (2025-10-27)2025-10-27
IBSPOT.com Inc. - FDA Warning Letter (2025-10-27)2025-10-27
Uriel Pharmacy, Inc. - FDA Warning Letter (2025-10-21)2025-10-21
Liebel-Flarsheim Company LLC - FDA Warning Letter (2025-10-17)2025-10-17
The Tranzonic Companies/Innocore Sales & Marketing Inc. - FDA Warning Letter (2025-10-16)2025-10-16
onlineotcmeds.com - FDA Warning Letter (2025-10-15)2025-10-15
PQ Pharmacy, LLC - FDA Warning Letter (2025-10-10)2025-10-10
RNA Bio/Pharma, Incorporated - FDA Warning Letter (2025-10-10)2025-10-10
Scientific Protein Laboratories, LLC - FDA Warning Letter (2025-10-10)2025-10-10
Acme United Corporation - FDA Warning Letter (2025-10-10)2025-10-10
Foshan Yiying Hygiene Products Co., Ltd. - FDA Warning Letter (2025-10-10)2025-10-10
Taizhou Kangping Medical Science and Technology Co., Ltd. - FDA Warning Letter (2025-10-09)2025-10-09
Melcare Biomedical Pty Ltd - FDA Warning Letter (2025-10-09)2025-10-09
www.usmedschoice.com - FDA Warning Letter (2025-10-06)2025-10-06
Guangxi Yulin Pharmaceutical Group Co. Ltd. - FDA Warning Letter (2025-09-30)2025-09-30
Naturich Cosmetique Labs - FDA Warning Letter (2025-09-25)2025-09-25
Creative Essences, Inc. - FDA Warning Letter (2025-09-25)2025-09-25
Persōn & Covey, Inc. - FDA Warning Letter (2025-09-23)2025-09-23
Revive Rx LLC dba Revive Rx Pharmacy - FDA Warning Letter (2025-09-22)2025-09-22
Kath Khemicals LLC - FDA Warning Letter (2025-09-22)2025-09-22
Pamela K. Den Besten, DDS, MS - FDA Warning Letter (2025-09-19)2025-09-19
BRS Analytical Services, LLC - FDA Warning Letter (2025-09-17)2025-09-17
Dixon Investments Inc. dba ARI - FDA Warning Letter (2025-09-17)2025-09-17
Ralph A. DeFronzo, M.D. - FDA Warning Letter (2025-09-17)2025-09-17
Turbare Manufacturing - FDA Warning Letter (2025-09-16)2025-09-16
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