Integra Burlington Ma Inc Formerly Integra Radionics Inc

FDA Filings

This page includes the latest FDA filings for Integra Burlington Ma Inc Formerly Integra Radionics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number1222895
FEI Number1000120652
NameIntegra Burlington MA, Inc. (formerly Integra Radionics, Inc
Owner & OperatorINTEGRA LIFESCIENCES CORPORATION
Contact Address1100 Campus Rd
Princeton NJ 08540 US
Official Correspondent
  • Eileen A Friedeborn
  • x-609-9371941-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address85 Rangeway Road Building 2, Floor1
N Billerica, MA 01862 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device
Company
DeviceDate
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
CRW2016-12-21
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
CRW-1 System2016-12-21
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
CRW Precision Arc Steriotactic System2016-12-21
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
Flex Extension Cable2012-08-24
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
Camino Flex Ventricular Intracranial Pressure Monitoring Kit2012-08-24
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth Confirmation Helmet (DH-1)2012-06-14
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
Integra LED Surgical Headlight2011-07-27
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
XKnife 52011-02-24
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
StereoCalc2011-01-11
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
SCS-22011-01-11
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
ProXenon2010-08-31
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
Linac Collimator Assembly Housing2010-07-28
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
LCAHART2010-07-28
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
CUSA Shear Tip2009-08-27
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
Ruggles-Redmond2008-12-15
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
Luxtec MLX Light Source2008-11-26
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
Primelink2007-12-12
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
ELink2007-12-12
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
Tarbell-Loeffler Cosman Pediatric F2007-12-12
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
XKnife MMLC2007-12-12
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
XKnife RT 42007-12-12
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
Radionics Slice Editor Imaging Software Utility2007-12-12
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
Atlas Plan2007-12-12
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
Pena Muscle Stimulator2007-12-12
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
Gill-Thomas Cosman GTC Dental Tray2007-12-12
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
CRW2007-12-12
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
CRW-1 System2007-12-12
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
CRW Precision Arc Sterotactic System2007-12-12
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
LCM-2-Linac Couch-Mount System2007-12-12
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
InterFix Patient Adapters2007-12-12
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
CUSA Selector Saber Tip2007-12-12
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
ImageFusion2007-12-12
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
ImageFusion 32007-12-12
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE2007-12-12
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
Nashold Biopsy Needle - Single Use2007-12-12
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
Nashold Biopsy Needle - Disposable2007-12-12
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
CRW Biopsy Plus2007-12-12
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
Radionics Varilink 22007-12-12
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
Xomed2007-12-04
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
Ultralite2007-12-04
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
Padgett2007-12-04
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
MicroFrance2007-12-04
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
Luxtec Light Sources2007-12-04
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
UltraLite2007-12-04
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
Luxtec Headlight Systems2007-12-04
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
Saber Tip2005-10-03
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
CUSA Excel Ultrasonic Surgical Aspirator2005-10-03
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
Xomed2003-07-25
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
Padgett2003-07-25
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
Miltex2003-07-25
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
MicroFrance2003-07-25
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
Luxtec2003-07-25
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
Integra-Luxtec2003-07-25
Integra Burlington MA, Inc. (formerly Integra Radionics, Inc [INTEGRA LIFESCIENCES CORPORATION]
Ojemann Cortical Stimulator1998-02-05

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