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Center for Drug Evaluation and Research (CDER)

946 FDA 510(k) clearances · Issuing office

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RecordFirmDate
Aeroflex Industria de Aerosol Ltda. - FDA Warning Letter (2026-05-22)2026-05-22
Alchymars ICM SM Private Limited - FDA Warning Letter (2026-05-21)2026-05-21
HealthPartners Neuroscience Center Research and Innovation - FDA Warning Letter (2026-05-19)2026-05-19
Sato Pharmaceutical Co., Ltd. - FDA Warning Letter (2026-05-18)2026-05-18
GSC Products, LLC - FDA Warning Letter (2026-05-18)2026-05-18
Aja Health and Wellness Inc. - FDA Warning Letter (2026-05-18)2026-05-18
GC America, Inc. - FDA Warning Letter (2026-05-14)2026-05-14
Lus Essentials LLC - FDA Warning Letter (2026-05-14)2026-05-14
La Crema De Rebeca - FDA Warning Letter (2026-05-14)2026-05-14
PolleyMed, LLC - FDA Warning Letter (2026-05-14)2026-05-14
Fagron BV - FDA Warning Letter (2026-05-12)2026-05-12
Naseem A. Jaffrani, M.D. - FDA Warning Letter (2026-05-04)2026-05-04
Naveh Pharma LTD/Bigdam Inc. - FDA Warning Letter (2026-05-04)2026-05-04
IDO Pharm Co., Ltd. - FDA Warning Letter (2026-05-04)2026-05-04
Harbin Jixianglong Biotech Co., Ltd. - FDA Warning Letter (2026-05-01)2026-05-01
CareFusion 213, LLC - FDA Warning Letter (2026-04-30)2026-04-30
Sourav K. Mishra, M.D. / All India Institute of Medical Sciences - FDA Warning Letter (2026-04-29)2026-04-29
Mukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research Centre - FDA Warning Letter (2026-04-29)2026-04-29
Ray’s Vitamins - FDA Warning Letter (2026-04-24)2026-04-24
ibeautistore.com - FDA Warning Letter (2026-04-24)2026-04-24
Active Cosmetics Manufacturing Inc. - FDA Warning Letter (2026-04-22)2026-04-22
Respilon Production S.R.O. - FDA Warning Letter (2026-04-20)2026-04-20
Foshan Miwei Cosmetics Co., Ltd. - FDA Warning Letter (2026-04-20)2026-04-20
SaNOtize - FDA Warning Letter (2026-04-17)2026-04-17
JW Nutritional LLC - FDA Warning Letter (2026-04-15)2026-04-15
Hangzhou Yiqi Biotechnology Co., Ltd - FDA Warning Letter (2026-04-15)2026-04-15
Par Health USA, LLC & Endo USA, Inc. - FDA Warning Letter (2026-04-15)2026-04-15
Ava Inc. - FDA Warning Letter (2026-04-14)2026-04-14
New Life Pharma LLC - FDA Warning Letter (2026-04-14)2026-04-14
Pro Numb Tattoo Numbing Spray, LLC - FDA Warning Letter (2026-04-14)2026-04-14
UCSF Radiopharmaceutical Facility - FDA Warning Letter (2026-04-13)2026-04-13
Medical Products Laboratories, Inc. - FDA Warning Letter (2026-04-09)2026-04-09
ProRx LLC - FDA Warning Letter (2026-04-07)2026-04-07
Lexia LLC - FDA Warning Letter (2026-04-07)2026-04-07
Chemco Corporation - FDA Warning Letter (2026-04-07)2026-04-07
Purolea Cosmetics Lab - FDA Warning Letter (2026-04-02)2026-04-02
Beauty of Aztlan LLC - FDA Warning Letter (2026-04-02)2026-04-02
Dry Springs Pharmacy - FDA Warning Letter (2026-04-01)2026-04-01
Online Rx Medz - FDA Warning Letter (2026-04-01)2026-04-01
Rxgoodusa - FDA Warning Letter (2026-04-01)2026-04-01
Pure Indulgence Aesthetics - FDA Warning Letter (2026-04-01)2026-04-01
Lovega LLC dba Pink Pony Peptides - FDA Warning Letter (2026-03-31)2026-03-31
Guangzhou Huli Technology Co., Ltd. dba Fantasy Face - FDA Warning Letter (2026-03-31)2026-03-31
Gram Peptides - FDA Warning Letter (2026-03-31)2026-03-31
Prime Sciences - FDA Warning Letter (2026-03-31)2026-03-31
FormPour - FDA Warning Letter (2026-03-31)2026-03-31
Mile High Compounds LLC - FDA Warning Letter (2026-03-31)2026-03-31
PekCura Labs - FDA Warning Letter (2026-03-31)2026-03-31
Intas Pharmaceuticals Limited - FDA Warning Letter (2026-03-30)2026-03-30
Ehsan Sadri, M.D. - FDA Warning Letter (2026-03-27)2026-03-27
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. - FDA Warning Letter (2026-03-23)2026-03-23
RC Outsourcing, LLC - FDA Warning Letter (2026-03-20)2026-03-20
Yangzhou H&R Plastic Daily Chemical Co., Ltd. - FDA Warning Letter (2026-03-18)2026-03-18
Microbiological Testing & Consulting, LLC - FDA Warning Letter (2026-03-16)2026-03-16
Patcos Cosmetics Pvt. Ltd. - FDA Warning Letter (2026-03-12)2026-03-12
OraLabs, Inc. - FDA Warning Letter (2026-03-11)2026-03-11
Flowchem Pharma Private Limited - FDA Warning Letter (2026-03-11)2026-03-11
Vedic Lifesciences Pvt. Ltd. - FDA Warning Letter (2026-03-09)2026-03-09
Novo Nordisk Inc. - FDA Warning Letter (2026-03-05)2026-03-05
Citra100mg - FDA Warning Letter (2026-03-04)2026-03-04
Simtra BioPharma Solutions - FDA Warning Letter (2026-03-03)2026-03-03
Tentamus India Private Limited - FDA Warning Letter (2026-03-03)2026-03-03
Fareva Morton Grove - FDA Warning Letter (2026-03-03)2026-03-03
NSE Products, Inc. DBA Nu Skin Enterprises, Inc. - FDA Warning Letter (2026-03-02)2026-03-02
Premium Health Management Inc. dba Premium Health - FDA Warning Letter (2026-02-20)2026-02-20
Bliv Wellness LLC dba Bliv - FDA Warning Letter (2026-02-20)2026-02-20
BluefitMD - FDA Warning Letter (2026-02-20)2026-02-20
Deluxe IV Aesthetics PLLC dba Deluxe IV and Aesthetics - FDA Warning Letter (2026-02-20)2026-02-20
Aspen Aesthetics dba Fifty 410 - FDA Warning Letter (2026-02-20)2026-02-20
FitRX, LLC dba FitRx - FDA Warning Letter (2026-02-20)2026-02-20
Genesis Health International Inc. dba Genesis - FDA Warning Letter (2026-02-20)2026-02-20
Zeuss LLC dba Zeuss - FDA Warning Letter (2026-02-20)2026-02-20
Lean Rx, Inc. dba SkinnyRx - FDA Warning Letter (2026-02-20)2026-02-20
Kare Solutions, LLC dba Zappy - FDA Warning Letter (2026-02-20)2026-02-20
Strut Health, LLC dba Strut - FDA Warning Letter (2026-02-20)2026-02-20
Refills Health, LLC dba Refills Health - FDA Warning Letter (2026-02-20)2026-02-20
Weightless Medical LLC dba WeightCare - FDA Warning Letter (2026-02-20)2026-02-20
Viv Health, Inc. dba VIV RX - FDA Warning Letter (2026-02-20)2026-02-20
Peaks Curative, LLC dba Peaks - FDA Warning Letter (2026-02-20)2026-02-20
PharmaZee - FDA Warning Letter (2026-02-20)2026-02-20
Good Girl LLC dba GoodGirlRX - FDA Warning Letter (2026-02-20)2026-02-20
Ivim Services LLC dba Ivim - FDA Warning Letter (2026-02-20)2026-02-20
Join Josie - FDA Warning Letter (2026-02-20)2026-02-20
Kin Meds - FDA Warning Letter (2026-02-20)2026-02-20
Levity Inc. dba Levity - FDA Warning Letter (2026-02-20)2026-02-20
MaxLife Technologies Inc. dba Maxlife - FDA Warning Letter (2026-02-20)2026-02-20
Better Health Labs, Inc. dba Measured - FDA Warning Letter (2026-02-20)2026-02-20
MEDVi, LLC dba MEDVi - FDA Warning Letter (2026-02-20)2026-02-20
Newman Clinic, PLLC dba Newman Clinic - FDA Warning Letter (2026-02-20)2026-02-20
NewSelf Limited dba NewSelf - FDA Warning Letter (2026-02-20)2026-02-20
24HrDoc, Inc. dba 24HrDoc - FDA Warning Letter (2026-02-20)2026-02-20
Alan Health Technologies Inc. dba Alan - FDA Warning Letter (2026-02-20)2026-02-20
Dripgym Mobile Parent, LLC dba Amp Health - FDA Warning Letter (2026-02-20)2026-02-20
Belle Health LLC dba Belle - FDA Warning Letter (2026-02-20)2026-02-20
A. Nelson & Co. Ltd. - FDA Warning Letter (2026-02-12)2026-02-12
AQ USA Inc., d.b.a Ross Healthcare Inc. - FDA Warning Letter (2026-02-12)2026-02-12
Thrive Health and Wellness, LLC dba Thrive Health Solutions - FDA Warning Letter (2026-02-09)2026-02-09
Cosmetic Manufacturers Pty Ltd. - FDA Warning Letter (2026-02-06)2026-02-06
Beach Weekend Management LLC dba Nic and Jet Fuel - FDA Warning Letter (2026-02-05)2026-02-05
Bio-Medical Pharmaceutical Manufacturing Corporation - FDA Warning Letter (2026-02-05)2026-02-05
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Every clearance here is in the API, with alerts when new ones post.