FDA.reportPublic FDA data

BAY SHORE MEDICAL EQUIPMENT, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30058103333005810333BAY SHORE MEDICAL EQUIPMENT, LLC1Y2026-01-0161 Deer Lane Manorville NY US 11949

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1303381277407081P080003SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMOTE2011-02-11
1303381950956967K992731E.CAM COMPUTERKPS1999-11-10
1303381612869077K992135SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEMLNH1999-09-08
1303382034493743K982795PHILIPS BUCKY VISIONMQB1998-11-24
1303382008391344K982787ASTEION CT SCANNER, TSX-021AJAK1998-10-21
1303381230803553K980176HISPEED QX/I CT SCANNER SYSTEMJAK1998-04-13
1303381951462250K971684MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE)LNH1997-08-05
1303381505251186K963093SIREMOBIL COMPACTOXO1996-09-03
1303381309145019K962738MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMSKPS1996-10-10
1303381844539091K913732MAMMOGRAPHIC X-RAY SYSTEMIZH1992-02-03
1303381755080539K910115PHILIPS BV-29 IMAGING SYSTEMOXO1991-02-20
1303381335829148K902983SIEMEN'S SIREMOBILE II C-ARMJAA1990-11-06
1303381826455336K802047AMX-IIIIZL1980-10-23
1303381410046629K132376DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5TLNH2013-11-15
1303381593227349K131937VOLUSON I/EIYN2013-09-24
1303381586415267K130842ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIESIZI2013-05-21
1303381034599877K122286MAMMOMAL INSPIRATIONMUE2013-02-22
1303381891129542K122234OEC 9900 ELITEOWB2012-08-16
1303381369075411K120613OEC 9900 ELITEOXO2012-04-06
1303381221117743K112213VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEMIYN2011-09-01
1303381934108122K111646ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCRMUE2011-12-08
1303381263295671K092140GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTRASOUNDIYO2009-08-21
1303381786862609K082816GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEMJAK2008-10-08
1303381329551727K082761GE LIGHTSPEED 7.2 CT SCANNER SYSTEMJAK2008-10-08
1303381253576963K081496OPTIMA PET/CT 560KPS2008-06-12
1303381566237926K063559ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5LNH2007-01-04
1303381605439135K060993GE LOGIQ P5 AND A5IYN2006-05-03
1303381453199958K050380XARIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-660AIYN2005-02-23
1303381461640223K042368PRACTIX CONVENIOIZL2004-10-04
1303381884226940K042023FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READERMQB2004-08-25
1303381780355514K041949ALLURA XPER FD10IZI2004-07-30
1303381657518528K041476GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEMLNH2004-06-17
1303381916151149K041112MAGNETOM ESPREE SYSTEMLNH2004-07-21
1303381683093104K040665SOMATOM SENSATION 64 AND SENSATION CARDIACJAK2004-04-02
1303381574654856K033418TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERSJAK2003-11-10
1303381747779560K033377FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP LLMC2004-01-09
1303381751713046K033326PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEMJAK2003-10-29
1303381047309649K033238MOBILETTE XP AND MOBILETT XPHYBRIDIZL2003-11-14
1303381523763777K032428MAGNETOM AVANTO MR SYSTEMLNH2003-10-16
1303381620613430K030934GE LOGIQ 9 MODEL 2375600IYN2003-04-17
1303381303223886K021829MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEMMQB2002-07-02
1303381409038550K021491HISPEED DUALJAK2002-05-22
1303381982224479K021049OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEMOWB2002-04-17
1303381648866937K021016AMX-4 PLUS MOBILE X-RAY SYSTEMIZL2002-06-17
1303381559683079K013561LIGHTSPEED 4.0 CT SCANNER SYSTEMJAK2001-11-08
1303381085233670K013344INTERA I/TLNH2001-12-11
1303381377835316K010435PHILIPS BV PULSERA/ENDURAOWB2001-03-12
1303381452347816K003837FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEMOXO2001-03-12
1303381158919586K002584ECAT ACCEL PET SCANNERKPS2000-11-16
1303381897110128K001796GYROSCAN INTERA (R7.5)LNH2000-09-06

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LNH92013-11-15
JAK92008-10-08
IYN52013-09-24
OXO42012-04-06
KPS42008-06-12
IZL42004-10-04
OWB32012-08-16
MQB32004-08-25
IZI22013-05-21
MUE22013-02-22
OTE12011-02-11
IYO12009-08-21
LMC12004-01-09
IZH11992-02-03
JAA11990-11-06