FDA.reportPublic FDA data

INTERACOUSTICS A/S

Matched from indexed company URL: INTERA CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
97100513000254565INTERACOUSTICS A/S1N2026-01-01Audiometer Alle 1 Middelfart Syddanmark DK 5500
30155373183015537318INTERA ONCOLOGY1N2026-01-01180 Wells Avenue Suite 300A Newton MA US 02459
30155373183015537318INTERA ONCOLOGY1N2020-04-2565 William Street Suite 200 Wellesley MA US 02481

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3405071338635668P890055MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEMLKK1996-03-11
2392291666124646P890055MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEMLKK1996-03-11
2392291474225635P800036INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4LKK1982-03-03
89321906213908K994254INTERACOUSTICS AT235 IMPEDANCE AUDIOMETERETY2000-03-14
89321785060908K983832INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETERETY1999-01-25
89321106775538K941848INTERACOUSTICS. HEARING AID ANALYZERETW1994-05-23
89321819999775K930553CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENTEWO1993-09-29
89321775317290K873298ELEC-TIPGXY1987-11-24
89321235083187K863424COMPUTER EYE TRACKING SYS./ENG EXAM. CHAIR & TABLEGWN1987-03-23
3405071722198476K213823Intera Refill KitPTI2022-03-16
3405071882888647K211121Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep KitPTI2021-10-14
89321036711084K200534VisualEyesGWN2020-08-12
89321375015225K192652TRVLXV2020-05-27
89321057216473K191372LyraEWO2019-07-15
89321590324444K173567SeraEWO2018-02-14
89321592137166K163149VisualEyesGWN2017-04-26
89321244513930K152112VisualEyesGWN2015-12-29
89321063679309K151616AT235ETY2015-07-15
89321116524987K150491ER36 Series OAE Test SystemEWO2015-03-26
89321530924983K131681EYESEECAM VHITGWN2013-09-06
89321063320154K111737DISPOSABLE ELECTRODEGXY2011-10-14
89321504179953K102364NYDIAG 200LXV2010-12-23
89321355459559K083861TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITEETY2009-04-09
89321673398325K082035MAICO MB 11 WITH BERAPHONE PROBEGWJ2009-01-29
89321267782720K072254VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEMGWN2008-02-05
89321419825408K070696INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)GWJ2007-06-29
89321274055937K060539DPOAE20 , ECLIPSEEWO2006-05-30
89321546386259K052562ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.EWO2005-12-23
89321922908374K050496REM440ETW2005-04-29
89321854741327K043219AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMSEWO2005-02-04
89321622292990K030016TEOAE25EWO2003-03-28
89321742441961K022728AUDIOTRAVELLER, MODEL AA222ETY2002-10-11
89321366456844K022311RHINOSTREAM RHINOMANOMETER MODULEBXQ2002-10-04
89321997550066K011746MB 11GWJ2001-08-24
89321974473506K011114ETYMOTIC RESEARCH ER-10D OAE PROBEEWO2001-07-03
89321405840536K010165ERO SCAN OAE TEST SYSTEMEWO2001-03-12
89321690101228K000406RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULEBXQ2000-04-17
89321048328367
89321087560048
89321169514171
89321277597296
89321367996066
89321568135695
89321571068749
89321590295551
89321719162443
89321737586131
89321862938449
89321886575972
89321924940323
89322032565006

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EWO102019-07-15
GWN62020-08-12
ETY52015-07-15
GWJ32009-01-29
PTI22022-03-16
LXV22020-05-27
GXY22011-10-14
ETW22005-04-29
BXQ22002-10-04
LKK21996-03-11
LKK 11982-03-03

PMA#

Intera 3000 Hepatic Artery Infusion Pump

2022-09-29

Intera Oncology65 William Streetsuite 200wellesley, MA 02481 PMA NumberP890055 Supplement NumberS083 Date Received08/30/2022 Decision Date09/29/2022 Product Code LKK  Advisory Committee General Hospital Supplement Type30-day Notice Supplement Reason Process...

Intera 3000 Hepatic Artery Infusion Pump

2022-06-22

Intera Oncology65 William Streetsuite 200wellesley, MA 02481 PMA NumberP890055 Supplement NumberS081 Date Received05/27/2022 Decision Date06/22/2022 Product Code LKK  Advisory Committee General Hospital Supplement Typespecial (immediate Track) Supplement Re...

Intera 3000 Hepatic Artery Infusion Pump

2022-05-20

Intera Oncology65 William Streetsuite 200wellesley, MA 02481 PMA NumberP890055 Supplement NumberS080 Date Received04/26/2022 Decision Date05/20/2022 Product Code LKK  Advisory Committee General Hospital Supplement Type30-day Notice Supplement Reason Process...

PMN#

TRV

2020-05-27

Interacoustics A/S

Lyra

2019-07-15

Interacoustics A/S

Sera

2018-02-14

Interacoustics A/S

AT235

2015-07-15

INTERACOUSTICS A/S

TITAN

2013-06-20

INTERACOUSTICS A/S

TITAN

2012-11-29

INTERACOUSTICS A/S

TITAN

2011-05-05

INTERACOUSTICS A/S

REM440

2005-04-29

INTERACOUSTICS A/S, ASSENS

TEOAE25

2003-03-28

INTERACOUSTICS A/S, ASSENS

GUDID#

80 records. Showing 1-40. Next