Hart Enterprises Inc

FDA Filings

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

FDA Registration(s)
Registration Number1828424
FEI Number1828424
NameHART ENTERPRISES, INC.
Owner & OperatorHART ENTERPRISES, INC.
Contact Address400 APPLEJACK CT. --
Sparta MI 49345 US
Official Correspondent
  • ROBERT L STRIEBEL
  • x-616-8870400-14
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address400 APPLEJACK CT.
SPARTA, MI 49345 US
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Device in the United States for Export Only

FDA Filings

Device
Company
DeviceDate
HART ENTERPRISES, INC.
Seldinger Needle2012-08-07
HART ENTERPRISES, INC.
Biogun2007-12-14
HART ENTERPRISES, INC.
Biopsy Needle Insert2007-12-14
HART ENTERPRISES, INC.
Breast Localization Needle2007-12-14
HART ENTERPRISES, INC.
Wescott Needle2007-12-14
HART ENTERPRISES, INC.
Sure-Grip Flashback2007-12-14
HART ENTERPRISES, INC.
Myelography Needle2007-12-14
HART ENTERPRISES, INC.
Spine Needle2007-12-14
HART ENTERPRISES, INC.
Spinal Needle2007-12-14
HART ENTERPRISES, INC.
Madayag Needle2007-12-14
HART ENTERPRISES, INC.
Chiba Needle2007-12-14
HART ENTERPRISES, INC.
Cournand Needle2007-12-14
HART ENTERPRISES, INC.
CHIBA NEEDLE2002-04-11
HART ENTERPRISES, INC.
MYELOGRAPHY2002-04-11
HART ENTERPRISES, INC.
WESTCOTT STYLE1994-10-05
HART ENTERPRISES, INC.
NOTCH NEEDLE1994-10-05
HART ENTERPRISES, INC.
NEEDLE INSERT FOR SOFT TISSUE BIOPS1994-10-05
HART ENTERPRISES, INC.
BIOGUN1994-10-05
HART ENTERPRISES, INC.
PENCIL POINT SPINAL NEEDLE1993-08-26
HART ENTERPRISES, INC.
AUTOMATED BIOPSY DEVICE, MODIFICATION1991-10-30
HART ENTERPRISES, INC.
NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE1989-01-26
HART ENTERPRISES, INC.
BREAST LOCALIZATION NEEDLES1988-05-13

Related Finance Registrations
NCAGE Code0TGS0HART ENTERPRISES INC
NCAGE Code48XN3HART ENTERPRISES INC!DBA GOLDEN HART PUBLISHING
CAGE Code0TGS0HART ENTERPRISES INC
CAGE Code48XN3HART ENTERPRISES INC GOLDEN HART PUBLISHING HART ENTERPRISES
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
201912091210Hong Kong,Hong Kong -> New York/Newark Area, Newark, New JerseyPLASTIC TOYS-JIGGLES146 CTN
2019120627801Yantian,China (Mainland) -> Seattle, WashingtonSQUIGGLE WIGGLE WRITER750 CTN
201912052568Hong Kong,Hong Kong -> New York/Newark Area, Newark, New JerseyPLASTIC TOYS-JIGGLES146 CTN
20190904467Yantian,China (Mainland) -> Tacoma, WashingtonPLASTIC TOYS752 CTN
201905213060Yantian,China (Mainland) -> Tacoma, WashingtonPLASTIC TOYS752 CTN
2019043026221Yantian,China (Mainland) -> Tacoma, WashingtonPLASTIC TOYS752 CTN
201901318741Hong Kong,Hong Kong -> New York/Newark Area, Newark, New JerseySTIC TOYS - JIGGLES209 CTN
20180911396Hong Kong,Hong Kong -> New York/Newark Area, Newark, New JerseyPLASTIC TOYS-JIGGLES84 CTN
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