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Center for Drug Evaluation and Research (CDER)

946 FDA 510(k) clearances · Issuing office

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RecordFirmDate
Stellalife, Inc. - FDA Warning Letter (2025-09-16)2025-09-16
Media Networks Sydney Pty. Limited - FDA Warning Letter (2025-09-16)2025-09-16
Chengdu Brilliant Biopharmaceutical Co., Ltd. - FDA Warning Letter (2025-09-11)2025-09-11
Columbia Cosmetics Manufacturing Inc. - FDA Warning Letter (2025-09-11)2025-09-11
motionpharmacy.com - FDA Warning Letter (2025-09-10)2025-09-10
Expert Aesthetics - FDA Warning Letter (2025-09-09)2025-09-09
Dermacare LLC dba BlueChew - FDA Warning Letter (2025-09-09)2025-09-09
Healthy Living Clinic - FDA Warning Letter (2025-09-09)2025-09-09
Hims & Hers Health, Inc. dba Hers - FDA Warning Letter (2025-09-09)2025-09-09
Amazing Meds - FDA Warning Letter (2025-09-09)2025-09-09
GenLabMeds - FDA Warning Letter (2025-09-09)2025-09-09
FitRX, LLC dba Zealthy - FDA Warning Letter (2025-09-09)2025-09-09
Get.Fit.Medical, LLC dba Get.Fit.Medical - FDA Warning Letter (2025-09-09)2025-09-09
FWD Care, Inc. dba FWD - FDA Warning Letter (2025-09-09)2025-09-09
iVisitDoc, Inc. dba iVisitDoc - FDA Warning Letter (2025-09-09)2025-09-09
Lean Dreams LLC dba LeanDreams - FDA Warning Letter (2025-09-09)2025-09-09
ybycmeds - FDA Warning Letter (2025-09-09)2025-09-09
Try Nova - FDA Warning Letter (2025-09-09)2025-09-09
The HCG Institute - FDA Warning Letter (2025-09-09)2025-09-09
Vitals RX - FDA Warning Letter (2025-09-09)2025-09-09
Las Villas Health Care LLC dba Villas Health - FDA Warning Letter (2025-09-09)2025-09-09
Tuyo Health, Inc. dba Tuyo Health - FDA Warning Letter (2025-09-09)2025-09-09
Lovely Meds, Inc. dba Lovely Meds - FDA Warning Letter (2025-09-09)2025-09-09
Lyfe Rx - FDA Warning Letter (2025-09-09)2025-09-09
Aytu Biopharma - FDA Warning Letter (2025-09-09)2025-09-09
Aytu Biopharma - FDA Warning Letter (2025-09-09)2025-09-09
Yangzhou Yulou Paper Products Co., Ltd. - FDA Warning Letter (2025-09-09)2025-09-09
inspire.clinic - FDA Warning Letter (2025-09-09)2025-09-09
Bioverse, Inc. dba Bioverse - FDA Warning Letter (2025-09-09)2025-09-09
SimpleRx - FDA Warning Letter (2025-09-09)2025-09-09
Elevate Your Wellness LLC, dba Elevated - FDA Warning Letter (2025-09-09)2025-09-09
Cosmo Medical Spa dba Cosmo Med Spa - FDA Warning Letter (2025-09-09)2025-09-09
EvoLife Wellness - FDA Warning Letter (2025-09-09)2025-09-09
eDrugstore - FDA Warning Letter (2025-09-09)2025-09-09
Nuvo Life Health Inc. dba Nuvo Life Health - FDA Warning Letter (2025-09-09)2025-09-09
SemaBio - FDA Warning Letter (2025-09-09)2025-09-09
directmeds.com, Inc. dba DirectMeds - FDA Warning Letter (2025-09-09)2025-09-09
Hims & Hers Health, Inc. dba Hims - FDA Warning Letter (2025-09-09)2025-09-09
MedClub by Dr. Jenn - FDA Warning Letter (2025-09-09)2025-09-09
Mane & Steel, LLC. dba Mane & Steel - FDA Warning Letter (2025-09-09)2025-09-09
Lumimeds - FDA Warning Letter (2025-09-09)2025-09-09
GLP-1 Solution - FDA Warning Letter (2025-09-09)2025-09-09
ASN-LABS - FDA Warning Letter (2025-09-09)2025-09-09
Body Good Studio - FDA Warning Letter (2025-09-09)2025-09-09
Canada Med Stop - FDA Warning Letter (2025-09-09)2025-09-09
All American Wellness - FDA Warning Letter (2025-09-09)2025-09-09
Healthy Male - FDA Warning Letter (2025-09-09)2025-09-09
Intimate Rose - FDA Warning Letter (2025-09-09)2025-09-09
Invigorate Med Spa - FDA Warning Letter (2025-09-09)2025-09-09
Dr. Gater’s Weight Loss & Wellness - FDA Warning Letter (2025-09-09)2025-09-09
Remedy Meds - FDA Warning Letter (2025-09-09)2025-09-09
EA WORKS Limited Liability Company dba Trust Labs - FDA Warning Letter (2025-09-09)2025-09-09
Fancy Meds, LLC dba Fancy Meds - FDA Warning Letter (2025-09-09)2025-09-09
Matthew Stern, CEO MyStart Health LLC. - FDA Warning Letter (2025-09-09)2025-09-09
Alora Pharmaceuticals - FDA Warning Letter (2025-09-09)2025-09-09
Elite Health Center - FDA Warning Letter (2025-09-09)2025-09-09
Curex - FDA Warning Letter (2025-09-09)2025-09-09
Healthon Inc. dba Healthon - FDA Warning Letter (2025-09-09)2025-09-09
JulyMD - FDA Warning Letter (2025-09-09)2025-09-09
Slendid - FDA Warning Letter (2025-09-09)2025-09-09
Hello Cake, Inc. dba Hello Cake - FDA Warning Letter (2025-09-09)2025-09-09
Biopreventative Company LLC dba Biopreventative - FDA Warning Letter (2025-09-09)2025-09-09
Sprout Health Partners LLC dba Sprout Health - FDA Warning Letter (2025-09-09)2025-09-09
Master Pharmaceuticals Group - FDA Warning Letter (2025-09-09)2025-09-09
TRYM Health, Inc. dba TRYM Health - FDA Warning Letter (2025-09-09)2025-09-09
HealBerry - FDA Warning Letter (2025-09-09)2025-09-09
Reset IV, LLC dba Reset IV - FDA Warning Letter (2025-09-09)2025-09-09
Eli Lilly and Company - FDA Warning Letter (2025-09-09)2025-09-09
Novo Nordisk Inc. - FDA Warning Letter (2025-09-09)2025-09-09
Eli Lilly and Company - FDA Warning Letter (2025-09-09)2025-09-09
Eli Lilly and Company - FDA Warning Letter (2025-09-09)2025-09-09
PureRawz - FDA Warning Letter (2025-09-08)2025-09-08
Somerset Therapeutics Private Limited - FDA Warning Letter (2025-09-04)2025-09-04
Shirish M. Gadgeel, M.D. - FDA Warning Letter (2025-09-04)2025-09-04
Amneal Pharmaceuticals, LLC - FDA Warning Letter (2025-08-27)2025-08-27
Green Vitality dba Gr33n - FDA Warning Letter (2025-08-25)2025-08-25
My Holistic Honey c/o Shenzhen Qanhai Wanb Express Supply Chain Co., LTD - FDA Warning Letter (2025-08-25)2025-08-25
Homeopathic Educational Services dba Homeopathic Family Medicine - FDA Warning Letter (2025-08-25)2025-08-25
Mel Honey US - FDA Warning Letter (2025-08-25)2025-08-25
Supply Center USA - FDA Warning Letter (2025-08-25)2025-08-25
Trew Balance - FDA Warning Letter (2025-08-25)2025-08-25
Life Enthusiast Co-op - FDA Warning Letter (2025-08-25)2025-08-25
Wisconsin Pharmacal Company, LLC - FDA Warning Letter (2025-08-22)2025-08-22
Hikal Limited - FDA Warning Letter (2025-08-20)2025-08-20
Chromatography Institute of America dba Compounder’s International Analytical Laboratory - FDA Warning Letter (2025-08-20)2025-08-20
Anhui Hanbon Daily Chemical Co., Ltd. - FDA Warning Letter (2025-08-11)2025-08-11
Everlaan Organics, Inc. dba Maple Organics - FDA Warning Letter (2025-08-11)2025-08-11
ABBE Laboratories, Inc. - FDA Warning Letter (2025-08-06)2025-08-06
Vacation Inc. - FDA Warning Letter (2025-08-06)2025-08-06
Kalani AB dba Kalani Sunwear - FDA Warning Letter (2025-08-06)2025-08-06
K & Care Organics - FDA Warning Letter (2025-08-06)2025-08-06
Fallien Cosmeceuticals Ltd. dba Fallene Ltd. - FDA Warning Letter (2025-08-06)2025-08-06
Supergoop! - FDA Warning Letter (2025-08-06)2025-08-06
www.usaquickmeds.com - FDA Warning Letter (2025-08-01)2025-08-01
Confer With - FDA Warning Letter (2025-08-01)2025-08-01
cheaptrustedpharmacy.com - FDA Warning Letter (2025-07-29)2025-07-29
AlzClipp / UniUni - FDA Warning Letter (2025-07-29)2025-07-29
Health and Natural Beauty USA Corp. - FDA Warning Letter (2025-07-28)2025-07-28
Shiva Analyticals Private Limited - FDA Warning Letter (2025-07-23)2025-07-23
Janssen Vaccines Corp., A Johnson & Johnson Company - FDA Warning Letter (2025-07-18)2025-07-18
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