Harmac Medical Products Inc

FDA Filings

This page includes the latest FDA filings for Harmac Medical Products Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3011163668
FEI Number3011163668
NameJames Wagner
Owner & OperatorHARMAC MEDICAL PRODUCTS, INC.
Contact Address2201 BAILEY AVE. --
Buffalo NY 14211 US
Official Correspondent
  • James - Wagner
  • x-716-8974500-x
US Agent
Importing Logistics Registration
ImporterR.L. Jones Customhouse
Address8830 Siempre Viva Rd.
San Diego, CA 92154 UNITED STATES
Email Addresskherrera@rljones.com
Phone1 619 6618182
Importer TypeBroker
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2201 Bailey Ave.
Buffalo, NY 14211 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number1317547
FEI Number1317547
NameHARMAC MEDICAL PRODUCTS, INC.
Owner & OperatorHARMAC MEDICAL PRODUCTS, INC.
Contact Address2201 BAILEY AVE. --
Buffalo NY 14211 US
Official Correspondent
  • James - Wagner
  • x-716-8974500-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2201 BAILEY AVE.
BUFFALO, NY 14211 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Device in the United States for Export Only
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number3003630504
FEI Number3002468842
NameJames Wagner
Owner & OperatorHARMAC MEDICAL PRODUCTS, INC.
Contact Address2201 BAILEY AVE. --
Buffalo NY 14211 US
Official Correspondent
  • James - Wagner
  • x-716-8974500-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2201 Bailey Ave.
Buffalo, NY 14211 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
James Wagner [HARMAC MEDICAL PRODUCTS, INC.]
Guardian II Hemostasis Valve, Guardian II NC Hemostasis Valve2013-02-26
HARMAC MEDICAL PRODUCTS, INC.
HARMAC HUBER NEEDLE SAFETY DEVICE, H29840012002-08-29
HARMAC MEDICAL PRODUCTS, INC.
HARMAC BALLOON WEDGE PRESSURE CATHETER1997-10-16
HARMAC MEDICAL PRODUCTS, INC.
HARMAC BALLOON ANGIOGRAPHIC CATHETER1997-10-16
HARMAC MEDICAL PRODUCTS, INC.
HARMAC TEMPORARY PACING CATHETER WITH BALLOON1997-10-15
HARMAC MEDICAL PRODUCTS, INC.
HARMAC THERMODILUTION CATHETER1997-08-14
HARMAC MEDICAL PRODUCTS, INC.
HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET1997-08-14
HARMAC MEDICAL PRODUCTS, INC.
HARMAC QUADPOLAR MAPPING PACING CATHETER1997-06-25
HARMAC MEDICAL PRODUCTS, INC.
HARMAC EXTENSION INFUSION SET1995-09-01

Related Finance Registrations
NCAGE Code3YGE6HARMAC MEDICAL PRODUCTS INC
CAGE Code3YGE6HARMAC MEDICAL PRODUCTS INC
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092978948Genova,Italy -> New York/Newark Area, Newark, New JerseyARTICLES OF PLASTICS NESOI EXPANSION CHAMBER FOR MEDICAL TUBSET10 PKG
2020091947472Rotterdam,Netherlands -> New York/Newark Area, Newark, New JerseyPRESSURE DOME ASSEMBLY4 PLT
2020091654924Rotterdam,Netherlands -> New York/Newark Area, Newark, New JerseyPRESSURE DOME ASSEMBLY4 PLT
2020080665191Rotterdam,Netherlands -> New York/Newark Area, Newark, New JerseyPRESSURE DOME ASSEMBLY1 PLT
2020072357289Rotterdam,Netherlands -> New York/Newark Area, Newark, New JerseyPRESSURE DOME ASSEMBLY1 PLT
2020072261622Rotterdam,Netherlands -> New York/Newark Area, Newark, New JerseyPRESSURE DOME ASSEMBLY1 PLT
202007046238Genova,Italy -> Long Beach, CaliforniaEXPANSION CHAMBER FOR MEDICAL TUBSET10 PCS
2020070150152Rotterdam,Netherlands -> New York/Newark Area, Newark, New JerseyPRESSURE DOME ASSEMBLY3 PLT
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.