Needletech Products Inc

FDA Filings

This page includes the latest FDA filings for Needletech 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 Number: 3006283319
• FEI Number: 3006283319
• Name: NeedleTech Products, Inc.
• Owner & Operator: THERAGENICS CORP.
• Contact Address: 5203 BRISTOL INDUSTRIAL WAY --; Buford GA 30518 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 452 John L Dietsch Blvd ; N Attleboro, MA 02763 US
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
PMN K143252 | DQX NeedleTech Products, Inc. [THERAGENICS CORP.]	QuickTork Guidewire Torque Device (0.025"-0.040") (TOR-100-25)	2015-12-24
PMN K143252 | DQX NeedleTech Products, Inc. [THERAGENICS CORP.]	QuickTork Guidewire Torque Device (0.010"-0.020") (TOR-100-10)	2015-12-24
PMN K143252 NEEDLETECH PRODUCTS, INC.	Galt Tork, 0.010 To 0.020 Inches (yellow), Galt Tork, 0.025 To 0.040 Inches (orange)	2015-04-23
PMN K031173 | GDF NeedleTech Products, Inc. [THERAGENICS CORP.]	Guide Wire Introducer Needle	2011-05-03
PMN K100665 NEEDLETECH PRODUCTS, INC.	MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX	2010-06-24
GAA NeedleTech Products, Inc. [THERAGENICS CORP.]	SCP(TM) Delivery Cannula 8GA x 3.5"	2008-12-24
GAA NeedleTech Products, Inc. [THERAGENICS CORP.]	19g X 2 3/4 Premium Percutaneous Needle	2008-12-24
GAA NeedleTech Products, Inc. [THERAGENICS CORP.]	19g X 2 3/4 Premium Percutaneous Needle featuring Echogenic Tip	2008-12-24
PMN K031173 NEEDLETECH PRODUCTS, INC.	NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013	2003-07-23