A M Systems

FDA Filings

This page includes the latest FDA filings for A M Systems. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

A M Systems holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• KAESUNG CO., LTD.

FDA Registration(s)

• Registration Number: 3020614
• FEI Number: 3020614
• Name: A-M Systems
• Owner & Operator: A-M SYSTEMS, INC.
• Contact Address: 131 BUSINESS PARK LOOP ; Sequim WA 98382 US
• Official Correspondent:
  • ROBERT J THOMPSON
  • x-360-6838300-302
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 131 BUSINESS PARK LOOP ; Sequim, WA 98382 US
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
BZA A-M Systems [A-M SYSTEMS, INC.]	Nut and Nipple, Swivel Connector	2019-12-20
BTC A-M Systems [A-M SYSTEMS, INC.]	BAG, BREATHING	2019-12-17
PMN K130664 | CAH A-M Systems [A-M SYSTEMS, INC.]	HydroMax HMEF	2013-07-24
PMN K130664 A-M SYSTEMS	HYRDROMAX HMEF	2013-06-21
PMN K063526 | CAH A-M Systems [A-M SYSTEMS, INC.]	ViroMax	2009-10-09
PMN K000654 | CAH A-M Systems [A-M SYSTEMS, INC.]	VBMax	2007-11-26
BYG A-M Systems [A-M SYSTEMS, INC.]	OXYGEN	2001-05-29
EPN A-M Systems [A-M SYSTEMS, INC.]	NEBULIZER	1992-06-30
EPN A-M Systems [A-M SYSTEMS, INC.]	MEDICINAL	1992-06-30
DSF A-M Systems [A-M SYSTEMS, INC.]	VARIOUS SIZES OF RECO	1992-06-30
CAT A-M Systems [A-M SYSTEMS, INC.]	OXYGEN	1992-06-30
BYX A-M Systems [A-M SYSTEMS, INC.]	VARIOUS SIZES OF NON-STERILE	1992-06-30
BYX A-M Systems [A-M SYSTEMS, INC.]	LOW PRESSURE TUBIN	1992-06-30
BYP A-M Systems [A-M SYSTEMS, INC.]	VARIOUS SIZES OF NON-STERILE	1992-06-30
BYP A-M Systems [A-M SYSTEMS, INC.]	RUBBER RE-USEABLE MOUTHPIECE	1992-06-30
BYP A-M Systems [A-M SYSTEMS, INC.]	NON-STERILE PLASTIC R	1992-06-30
BXW A-M Systems [A-M SYSTEMS, INC.]	CAL-SYRINGE	1992-06-30
BXJ A-M Systems [A-M SYSTEMS, INC.]	PLASTIC DISPOSABLE NOSECLIP	1992-06-30
BSF A-M Systems [A-M SYSTEMS, INC.]	CARBON DIOXIDE	1992-06-30
BSF A-M Systems [A-M SYSTEMS, INC.]	ABSORBER	1992-06-30
CAX A-M Systems [A-M SYSTEMS, INC.]	FLOWMETER	1984-10-05
CAX A-M Systems [A-M SYSTEMS, INC.]	ANESTHESIA	1984-10-05

Similar & Related FDA Registered Companies

• Aesculap Inc. / Aesculap Implant Systems, LLC
• ACIST Medical Systems, Inc.
• Alcohol Countermeasure Systems Inc.
• ALFATECH TX MEDICAL SYSTEMS INC
• All Imaging Systems
• ACCUMED RADIAL SYSTEMS, LLC.
• ADIN DENTAL IMPLANT SYSTEMS Ltd
• ADROIT MEDICAL SYSTEMS, INC.
• Advanced Imaging Systems
• Advanced Ophthalmology Systems Ltd
• AESCULAP IMPLANT SYSTEMS, LLC
• ALCOHOL COUNTERMEASURE SYSTEMS CORP.
• AlfaTech Medical Systems
• ALLMED SYSTEMS INC.
• Alltech Medical Systems America Inc.
• Alpinion Medical Systems Co., Ltd.
• American Contract Systems
• Arteriocyte Medical Systems, Inc.
• Aspen Medical Systems, Corp.
• Avail Medsystems, Inc.
• Allengers Medical Systems Limited
• Adin Dental Implants Systems Ltd.
• A2 Medical Systems, LLC
• Aesculap Implants Systems, LLC
• Aesculap Implants Systems, Inc.
• ADVANCED IMAGING RESEARCH DBA SREE MEDICAL SYSTEMS
• Aesculap Implant Systems, Inc.
• AVANTIS MEDICAL SYSTEMS, INC.
• ACOUSTIC MEDSYSTEMS, INC.
• AMERICAN MEDICAL SYSTEMS
• AESCULAP IMPLANT SYSTEMS
• ACIST MEDICAL SYSTEMS
• AMERICAN MEDICAL SYSTEMS, INC.
• ANGEL MEDICAL SYSTEMS INC.788 Shrewsbury Ave Suite 2200tinton Falls, NJ 07724 PMA NumberP150009 Supplement NumberS008 Date Received08/19/2022 Decision Date09/21/2022 Product Code QBI  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• AESCULAP IMPLANT SYSTEMS, LLC3773 Corporate Parkwaycenter Valley, PA 18034 PMA NumberP120024 Supplement NumberS012 Date Received06/13/2022 Decision Date06/24/2022 Product Code MJO  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ANGEL MEDICAL SYSTEMS INC.788 Shrewsbury Ave Suite 2200tinton Falls, NJ 07724 PMA NumberP150009 Supplement NumberS007 Date Received04/27/2022 Decision Date05/19/2022 Product Code QBI  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• ANGEL MEDICAL SYSTEMS INC.
• AEROJET MEDICAL AND BIOLOGICAL SYSTEMS
• American Chemical Systems II, LLC
• AromaQuest Systems, LLC.
• A-M SYSTEMS, LLC
• Acutronic Medical Systems AG
• ADVANCED NEUROMODULATION SYSTEMS, INC.
• ALLEN MEDICAL SYSTEMS, INC.
• AMERICAN CONTRACT SYSTEMS, INC.
• AUGUSTA MEDICAL SYSTEMS, L.L.C.

Related Finance Registrations

NCAGE Code	0KJY8	A AND M SYSTEMS
NCAGE Code	0PXV0	A-M SYSTEMS
CAGE Code	0KJY8	A AND M SYSTEMS
CAGE Code	0PXV0	A-M SYSTEMS
DUNS	802871590	A M SYSTEMS