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No. of Records Found: 919

Company	Letter Issued	Issuing Office	Subject	Response Letter Posted
3TP LLC	10/05/2004	Center for Devices and Radiological Health	Premarket Approval/Misbranded	No
7-Day Miracle Cleanse	09/21/2004	Center for Devices and Radiological Health	Premarket Approval/Misbranded/Adulterate d	No
911 Water	05/13/2009	Center for Devices and Radiological Health	Unapproved/Uncleared/Unauthori zed Products Related to the H1N1 Flu Virus	No
ADI Corporation	12/18/2000	Center for Devices and Radiological Health	Television/Computer Monitor Factories/Automatic Detention	No
ADI Corporation	07/21/2000	Center for Devices and Radiological Health	Quality Control & Testing Program	No
APC Medical Ltd.	10/08/2002	Center for Devices and Radiological Health	QSR For Medical Device/Adulterated	No
APS (USA) Ltd.	05/24/2000	Center for Devices and Radiological Health	Action Potential Stimulation Therapy Device/Promotional Claims/Lacks Premarket Approval/Misbranded	No
ARJO, Ltd.	11/05/2001	Center for Devices and Radiological Health	Quality System Regulation/Adulterated	No
Aap Implantate AG	07/16/2004	Center for Devices and Radiological Health	CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated	No
Abadir Associates	11/28/2000	Center for Devices and Radiological Health	AdatoSil 5000/Misbranded/Adulterated/La cks Premarket Approval	No
Abbott Laboratories	11/05/1998	Center for Devices and Radiological Health	Sponsor/Monitor/Contract Research Organization	No
Abbott Vascular, Inc.	12/19/2007	Center for Devices and Radiological Health	Medical Devices/Adulterated/Misbranded	No
Access Genetics	07/29/2005	Center for Devices and Radiological Health	Lacks Premarket Notification Approval/Adulterated/Misbrande d	No
Accutech Orthodontic Laboratory	10/25/1999	Center for Devices and Radiological Health	Sleep Apnea Goldilocks (SAGA)/Marketing without PreMarket Notification Submission (510K)	No
Acon Laboratories Inc.	08/18/2000	Center for Devices and Radiological Health	Devices/Lacks Premarket Approval	No
Activa Brand Products	10/24/2000	Center for Devices and Radiological Health	Quality System Regulation/Needleless Insulin Injectors	No
Activa Brand Products, Inc.	01/30/2003	Center for Devices and Radiological Health	Quality System Regulation/Adulterated	No
Adams, Mark M.D.	01/23/2008	Center for Devices and Radiological Health	Investigational Device Exemptions	No
Advanced Bionics Corporation	09/24/2001	Center for Devices and Radiological Health	CII Bionic Ear/Lacks Approved Premarket Approval/Adulterated	No
Advanced Orthopaedics of South Florida	05/06/2008	Center for Devices and Radiological Health	Clinical Investigator (Sponsor)	No
Airway Clearing Tools	07/15/2004	Center for Devices and Radiological Health	Premarket Approval/Misbranded/Adulterate d	No
Aksys, Ltd	06/08/2006	Center for Devices and Radiological Health	Lacks Premarket Approval Application/Adulterated/Misbra nded	No
Alcon Laboratories Inc.	01/14/1999	Center for Devices and Radiological Health	Devices/Intraocular Lenses	No
All Medicus Co. Ltd	08/29/2007	Center for Devices and Radiological Health	CGMP for Medical Devices/Adulterated	No
Allegiance Corporation	11/05/2002	Center for Devices and Radiological Health	Lacks Premarket Approval/Adulterated/Misbrande d	No
Allen, Mark S., M.D.	01/28/2002	Center for Devices and Radiological Health	Clinical Investigator	No
Allerair Industries	05/14/2009	Center for Devices and Radiological Health	Unapproved/Uncleared/Unauthori zed Products Related to the H1N1 Flu Virus	No
Allergan Inc.	04/19/2000	Center for Devices and Radiological Health	AMO PhacoFlex II Intraocular Lens/Promotional Claims/Lacks Application for PMA/Misbranded etc.	No
Allgaier Instrumente GmbH	08/15/1997	Center for Devices and Radiological Health	Devices/Surgical Instruments	No
Alliance Medical, Inc.	01/20/2004	Center for Devices and Radiological Health	Premarket Approval/Misbranded/Adulterate d	No
Alliance Security Products, Inc.	01/14/2004	Center for Devices and Radiological Health	Premarket Approval/Misbranded/Adulterate d	No
Allied Health Association	10/02/2001	Center for Devices and Radiological Health	Lacks Premarket Approval/Not Substantially Equivalent/Adulterated	No
Allinace Rubber Products	05/18/2001	Center for Devices and Radiological Health	Patient Examination Gloves/Quality System Regulation/Adulterated	No
Almo Erzeugnisse Erzeugnisse Erwin Busch GmbH	08/03/2000	Center for Devices and Radiological Health	Quality System Regulation/Disposable Syringes	No
Alpha Pro Tech	01/14/2004	Center for Devices and Radiological Health	Premarket Approval/Misbranded/Adulterate d	No
Amedica Corporation	01/27/2009	Center for Devices and Radiological Health	Premarket Approval/Adulterated	No
America cheritable Fund Inc.	12/05/2000	Center for Devices and Radiological Health	IRB (Institutional Review Board)	No
American Association of Acupuncture and Bio-Energetic Medicine	11/13/2008	Center for Devices and Radiological Health	Institutional Review Board	No
American Bio Medica Corp	06/30/2009	Center for Devices and Radiological Health	Premarket Approval/Misbranded/Adulterate d	No
American Bio Medica Corporation	12/26/2000	Center for Devices and Radiological Health	Rapid Drug Screen/Adulterated/Lacks Premarket Approval/Misbranded	No
American Biogenetic Sciences Inc.	03/06/1997	Center for Devices and Radiological Health	In Vitro Diagnostic Products	No
American Medical Supply Inc.	04/29/1998	Center for Devices and Radiological Health	Medical Devices	No
American Ultraviolet Co.	06/04/2009	Center for Devices and Radiological Health	Unapproved/Uncleared/Unauthori zed Products Related to the H1N1 Flu Virus	No
Amplifon S.P.A.	01/10/1997	Center for Devices and Radiological Health	Devices/Diagnostic Systems	No
Amstutz, Harlan C., M.D.	07/19/2004	Center for Devices and Radiological Health	Clinical Investigator	No
Amyron Enterprises Pty Ltd.	05/12/2009	Center for Devices and Radiological Health	Unapproved/Uncleared/Unauthori zed Products Related to the H1N1 Flu Virus	No
Anam Electronics Co. Ltd.	11/24/1999	Center for Devices and Radiological Health	Electronic Product Radiation Control/Television Products Manufacturing	No
Anderson C. Joseph M.D.	02/25/2000	Center for Devices and Radiological Health	Clinical Investigator	No
Ani Safety & Supply Inc.	01/14/2004	Center for Devices and Radiological Health	Premarket Approval/Misbranded/Adulterate d	No
Ansell Perry de Mexico SA de CV	01/06/2000	Center for Devices and Radiological Health	Devices/Examination Gloves	No

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