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Center for Devices and Radiological Health

222 FDA 510(k) clearances · Issuing office

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RecordFirmDate
Optikem International, Inc. - FDA Warning Letter (2024-08-13)2024-08-13
Shenzhen Moyeah Intelligent Life Technology Co. - FDA Warning Letter (2024-08-08)2024-08-08
LEEL Tech - FDA Warning Letter (2024-08-07)2024-08-07
Adventure Innovations LLC - FDA Warning Letter (2024-08-07)2024-08-07
Natures Pillows, Inc. and Top Dog Direct, LLC - FDA Warning Letter (2024-08-07)2024-08-07
Jiangsu Shenli Medical Production Co., Ltd. - FDA Warning Letter (2024-07-18)2024-07-18
Jiangsu Caina Medical Co., Ltd - FDA Warning Letter (2024-07-18)2024-07-18
AMCO International Manufacturing & Design, Inc. - FDA Warning Letter (2024-06-25)2024-06-25
AG Essence, Inc. - FDA Warning Letter (2024-06-14)2024-06-14
Cue Health, Inc. - FDA Warning Letter (2024-05-09)2024-05-09
Cardinal Health - FDA Warning Letter (2024-04-24)2024-04-24
Pinnacle Labs of Tennessee, LLC dba Pinnacle BioLabs - FDA Warning Letter (2024-04-17)2024-04-17
Augustine Temperature Management, LLC - FDA Warning Letter (2024-03-21)2024-03-21
Agena Bioscience, Inc. - FDA Warning Letter (2024-03-21)2024-03-21
Jiangsu Shenli Medical Production Co., Ltd. - FDA Warning Letter (2024-03-18)2024-03-18
Medline Industries, LP - FDA Warning Letter (2024-03-18)2024-03-18
Royal Philips - FDA Warning Letter (2024-02-23)2024-02-23
Soulaire Corporation - FDA Warning Letter (2024-01-29)2024-01-29
Nobles Medical Technology II, Inc. - FDA Warning Letter (2024-01-26)2024-01-26
Exactech, Inc. - FDA Warning Letter (2024-01-19)2024-01-19
Dr. Joel Kaplan Inc. - FDA Warning Letter (2024-01-08)2024-01-08
Fresenius Kabi AG - FDA Warning Letter (2024-01-04)2024-01-04
Techlem Medical Corporation - FDA Warning Letter (2023-12-26)2023-12-26
Fresenius Medical Care AG & Co. KGaA - FDA Warning Letter (2023-12-04)2023-12-04
Wello Inc. - FDA Warning Letter (2023-11-08)2023-11-08
Terragene S.A. - FDA Warning Letter (2023-11-01)2023-11-01
Acrostak Schweiz AG - FDA Warning Letter (2023-10-31)2023-10-31
Neurotris, Inc. dba A1 Engineering - FDA Warning Letter (2023-10-27)2023-10-27
ReNovo, Inc. DBA Provision Device Reprocessing Solutions - FDA Warning Letter (2023-10-13)2023-10-13
Sonesta Medical AB - FDA Warning Letter (2023-09-22)2023-09-22
P.T. Sankei Medical Industries - FDA Warning Letter (2023-09-19)2023-09-19
BYD Precision Manufacture Co., Ltd - FDA Warning Letter (2023-09-05)2023-09-05
Caltag Medsystems Ltd - FDA Warning Letter (2023-08-31)2023-08-31
Neitz Instruments Company Ltd. - FDA Warning Letter (2023-08-25)2023-08-25
King Systems Corp. dba Ambu, Inc. - FDA Warning Letter (2023-08-16)2023-08-16
Outset Medical, Inc. - FDA Warning Letter (2023-07-05)2023-07-05
Vitang Technology LLC - FDA Warning Letter (2023-06-12)2023-06-12
Ming Fai Industrial Co LTD - FDA Warning Letter (2023-06-01)2023-06-01
iRhythm Technologies, Inc. - FDA Warning Letter (2023-05-25)2023-05-25
Steiner Biotechnology, LLC - FDA Warning Letter (2023-05-19)2023-05-19
I.T.S. GmbH - FDA Warning Letter (2023-05-19)2023-05-19
Future Diagnostics Solutions B.V. - FDA Warning Letter (2023-05-11)2023-05-11
Olympus Medical Systems Corp. - FDA Warning Letter (2023-03-15)2023-03-15
Medivance Instruments Ltd. - FDA Warning Letter (2023-02-13)2023-02-13
Cutera, Inc. - FDA Warning Letter (2023-02-08)2023-02-08
Fischer Analysen Instrumente Gmbh - FDA Warning Letter (2023-02-03)2023-02-03
Turkuaz Sağlik Hizmetleri Medikal Temizlik Kimyasa - FDA Warning Letter (2022-12-29)2022-12-29
North American Diagnostics, LLC - FDA Warning Letter (2022-12-27)2022-12-27
Getsch+Hiller Medizintechnik GmbH - FDA Warning Letter (2022-12-27)2022-12-27
Olympus Medical Systems Corporation - FDA Warning Letter (2022-12-12)2022-12-12
RoyalVibe Health Ltd. - FDA Warning Letter (2022-11-18)2022-11-18
Abbott Point of Care Canada Limited - FDA Warning Letter (2022-11-08)2022-11-08
Aizu Olympus Co., Ltd. - FDA Warning Letter (2022-11-02)2022-11-02
Empowered Diagnostics LLC - FDA Warning Letter (2022-10-06)2022-10-06
MicroVention Costa Rica S.R.L. - FDA Warning Letter (2022-09-30)2022-09-30
Med Pen Concepts, LLC - FDA Warning Letter (2022-09-15)2022-09-15
JAS Diagnostics/Drew Scientific, Inc. - FDA Warning Letter (2022-08-16)2022-08-16
Flawless Beauty and Skin - FDA Warning Letter (2022-08-05)2022-08-05
USA Medical LLC - FDA Warning Letter (2022-08-03)2022-08-03
NeuroField, Inc. - FDA Warning Letter (2022-02-28)2022-02-28
Lusys Laboratories, Inc. - FDA Warning Letter (2022-02-17)2022-02-17
CardioQuip, LLC - FDA Warning Letter (2022-02-11)2022-02-11
Skin Sheek - FDA Warning Letter (2022-01-28)2022-01-28
Wickimed Medical Equipment Manufacturing Co., Ltd. - FDA Warning Letter (2022-01-07)2022-01-07
Unimicro Medical Systems-Shenzhen Co., Ltd. - FDA Warning Letter (2022-01-06)2022-01-06
Medtronic, Inc. - FDA Warning Letter (2021-12-09)2021-12-09
DermaCare Biosciences, LTD. - FDA Warning Letter (2021-12-01)2021-12-01
DSAART, LLC. dba Alpha Aesthetics - FDA Warning Letter (2021-11-24)2021-11-24
Induction Therapies, LLC - FDA Warning Letter (2021-11-23)2021-11-23
Invacare Corporation - FDA Warning Letter (2021-11-18)2021-11-18
Global Medical Production Co Ltd - FDA Warning Letter (2021-11-16)2021-11-16
Owlet Baby Care, Inc. - FDA Warning Letter (2021-10-05)2021-10-05
Smiths Medical ASD Inc. - FDA Warning Letter (2021-10-01)2021-10-01
Databazaar.com - FDA Warning Letter (2021-09-03)2021-09-03
Invisi Smart Technologies UK LTD - FDA Warning Letter (2021-08-24)2021-08-24
Pairon Solutions LLC - FDA Warning Letter (2021-08-09)2021-08-09
Lepu Medical Technology -Beijing- Co., Ltd. - FDA Warning Letter (2021-07-29)2021-07-29
Vivera Pharmaceuticals, Inc. - FDA Warning Letter (2021-07-26)2021-07-26
Vivera Pharmaceuticals, Inc. - FDA Warning Letter (2021-07-26)2021-07-26
Lexion Medical LLC - FDA Warning Letter (2021-07-26)2021-07-26
Biopolygen Corp. - FDA Warning Letter (2021-07-09)2021-07-09
USH Diagnostics, Inc./covidinstanttest.net - FDA Warning Letter (2021-07-09)2021-07-09
Captain's Cloth LLC - FDA Warning Letter (2021-07-02)2021-07-02
Fixture Display LLC - FDA Warning Letter (2021-06-28)2021-06-28
World Packaging Solutions, LLC - FDA Warning Letter (2021-06-28)2021-06-28
Tianjin Bolang Science-Technology Development Co., Ltd. - FDA Warning Letter (2021-06-17)2021-06-17
Innova Medical Group, Inc. - FDA Warning Letter (2021-06-10)2021-06-10
Amplicon Land, LLC - FDA Warning Letter (2021-06-07)2021-06-07
Zhejiang Xichen Medical Technology Co., Ltd. - FDA Warning Letter (2021-06-04)2021-06-04
Nature’s Distributing; Club Clean Inc/BuyMedicalMasksNow.com - FDA Warning Letter (2021-05-28)2021-05-28
Irvin, Inc. - FDA Warning Letter (2021-05-27)2021-05-27
Dongguan City Xinyuan Nonwoven Co., Ltd. - FDA Warning Letter (2021-05-27)2021-05-27
Mask Supply Store - FDA Warning Letter (2021-05-21)2021-05-21
Nikkiso Medical America, Inc - FDA Warning Letter (2021-05-07)2021-05-07
Baltimore Beauty Security Square Mall - FDA Warning Letter (2021-05-04)2021-05-04
Professional World Store - FDA Warning Letter (2021-04-27)2021-04-27
BMHshop - FDA Warning Letter (2021-04-26)2021-04-26
Manhattan Stitching Company, Inc. - FDA Warning Letter (2021-04-13)2021-04-13
Anytime COVID Test LLC - FDA Warning Letter (2021-04-13)2021-04-13
Sethi Laboratories - FDA Warning Letter (2021-04-06)2021-04-06
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Every clearance here is in the API, with alerts when new ones post.