FDA.reportPublic FDA data

Integra Burlington MA, Inc. (formerly Integra Radionics, Inc

Matched from indexed company URL: INTEGRA BURLINGTON MA, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12228951000120652Integra Burlington MA, Inc. (formerly Integra Radionics, Inc1N2020-04-2585 Rangeway Road Building 2, Floor1 N Billerica MA US 01862

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
129751311601127K993594CONFORMAX MMLC VR1IYE1999-12-15
129751733607005K991523TLC PEDIATRIC FRAME, MODEL TLC-SYSIYE1999-07-30
129751421461965K983603REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAMEHAW1998-11-10
129751894017646K982549RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLCIYE1998-12-30
129751145214770K981597RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITYIYE1998-10-09
129751642441399K980584ATLASPLANHAW1998-05-18
129751827908289K980448MODEL PS-1 PENA MUSCLE STIMULATORIPF1998-04-03
129751292517985K962155GILL-THOMAS-COSMAN(GTC) DENTAL TRAYIYE1996-08-22
129751103965614K944463CRW-1 SYSTEMHAW1995-10-26
129751895678896K934523GILL-THOMAS-COSMAN (GTC) RELOCATABLE HEAD HOLDER SYSTEM WITH DEPTH CONFIRMATION HELMET(DH-1)IYE1995-02-08
129751524923413K924632LCM-2-LINAC COUCH-MOUNT SYSTEMIYE1993-04-07
129751570454509K924226OJEMANN CORTICAL STIMULATORGYC1993-04-21
129751569970218K864385LUXTEC LIGHT SOURCESFCW1987-01-13
129751845845260K864380LUTEX HEADLIGHT SYSTEMSFST1986-11-19
129751120797174K811452BROWN-ROBERTS-WELLS STEREOTAXIC SYTEMHAW1981-06-02
129751827993708K160811CRW STEREOTACTIC SYSTEMHAW2016-12-06
129751939106339K121159INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTERGWM2012-07-20
129751419483138K110528INTEGRA LED SURGICAL HEADLIGHT SYSTEMFSR2011-05-11
129751006197029K100417XKNIFE 5MUJ2010-04-08
129751735677125K100096LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHARTIYE2010-04-22
129751737532453K090864CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEMLFL2009-05-08
129751624616522K081477LUXTEC MLX LIGHT SOURCEFCW2008-06-18
129751640810908K072454INTEGRA RADIONICS INTERFIX PATIENT ADAPTERSIYE2007-10-16
129751886777497K071669INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIPLFL2007-08-17
129752033131406K071218PROXENON 350, MODEL 902XXFST2007-06-14
129751950502520K063230INTEGRA RADIONICS IMAGEFUSION 3MUJ2006-12-21
129752026484921K051947RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONELFL2005-08-22
129751054803178K032054RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USEHAW2003-09-15
129751997033968K023519RADIONICS VARILINK 2IYE2003-01-16
129751870506591

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYE102010-04-22
HAW62016-12-06
LFL32009-05-08
MUJ22010-04-08
FCW22008-06-18
FST22007-06-14
GWM12012-07-20
FSR12011-05-11
IPF11998-04-03
GYC11993-04-21

PMN#