FDA.reportPublic FDA data

SPECTRUM MEDICAL IMAGING CO

Matched from indexed company URL: SPECTRUM, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20273272027327SPECTRUM MEDICAL IMAGING CO1Y2026-01-011721 Stewart St Santa Monica CA US 90404
21839671000115735Spectrum Plastics Group1N2026-01-017309 WEST 27TH ST. Saint Louis Park MN US 55426
30026722253002672225SPECTRUM ASSEMBLY INC.1N2026-01-016300 Yarrow Dr SUITE 100 Carlsbad CA US 92011
30041940343004194034SPECTRUM TECHNOLOGIES1Y2026-01-011532 CHABLIS RD. No. 101 HEALDSBURG CA US 95448
30058552403005855240Spectrum Brands, Inc. (a Delaware Corporation)1Y2026-01-013001 Deming Way Middleton WI US 53562
30061264283006126428SPECTRUM MEDICAL INC1Y2026-01-01481 Munn Road, Suite 180 Fort Mill SC US 29715
30080073103008007310Spectrum Dynamics Medical Inc.1Y2026-01-01301 N. Cattlemen Rd. Suite 109 Sarasota FL US 34232
30127589463012758946SPECTRUM SOLUTIONS LLC1N2026-01-0112278 S Lone Peak Pkwy Ste 106 Draper UT US 84020
30307146603030714660SPECTRUM VASCULAR1N2026-01-0150 Main St. Suite 1000 White Plains NY US 10606
30328486313032848631SPECTRUM FERTILITY GROUP1Y2026-01-01867 Boylston Street, 5th Floor -#1984 Boston MA US 02116
30364964333036496433SPECTRUM SPINE INC1N2026-01-0120 Harmony Ct Jasper GA US 30143
20283061000125318SPECTRUM DESIGNS, INC.1N2020-04-25132 Easy St. Unit D5 Buellton CA US 93427
30060158323006015832Spectrum International, Inc.1N2020-04-252401 Stanwell Drive, Suite 340 Concord CA US 94520
30076118213007611821Spectrum Aeromed LLC1Y2020-04-251815 23rd Avenue N Fargo ND US 58102

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850301007020Wolf - "Sterile Equipment Drape, ENDOCAM Camera, 7""X96^"""+1(214)492-0506hfahrlander@spectrumlabs.com
00850301007808Spectrum, Inc. - Specimine Container, 16 Oz, Sterile+1(214)492-0506hfahrlander@spectrumlabs.com
00850301007860Spectrum, Inc. - "Strap-Stroll Stockinette, 4"" X 3', Sterile"+1(214)492-0506hfahrlander@spectrumlabs.com
00850301007877Spectrum, Inc. - "Strap-Stroll Stockinette, 4"" X 4 ', Sterile"+1(214)492-0506hfahrlander@spectrumlabs.com
00855495007344Spectrum, Inc. - "Sterile Equipment Drape, ESS Universal Camera Drape, 7"" X 96"", Latex Free"+1(214)492-0506hfahrlander@spectrumlabs.com
00855495007351Spectrum, Inc. - "Sterile Equipment Drape, 12"" X 100"" w/Bag Clip, Latex Free"+1(214)492-0506hfahrlander@spectrumlabs.com
00855495007368Spectrum, Inc. - "Sterile Equipment Drape, AssistArm Surgical Drape, 7"" X 96"", Latex Free"+1(214)492-0506hfahrlander@spectrumlabs.com
00855495007382Spectrum, Inc. - "Sterile Equipment Drape, Microlase, 5"" X 59"", latex Free"+1(214)492-0506hfahrlander@spectrumlabs.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3268951885000864K963097CLAMPLESS VALVED CATHETER-PICC (CVC-PICC)LJS1996-10-18
3268951117167607K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve TechnologyLJS2025-12-16
3268951693824114K250724Intraosseous Infusion NeedlesFMI2025-07-30
3378791883987665K240838Spectrum Spine Cervical Cage SystemODP2024-05-30
1597051147052839K230600VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)KPS2023-04-28
2277391856890584K223497Spectrum Saliva Collection DeviceQBD2023-02-17
1597051111926954K212230TruSPECT Radiological Image Processing StationLLZ2021-08-16
1597051348968376K190457VERITON CT whole body SPECT/CT systemKPS2019-07-12
887281042567990K190282Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)DTQ2019-05-24
1597051004438678K182484VERITON CT whole body SPECT/CT systemKPS2018-11-09
3268951545658736K182252Cook Unimpregnated Central Venous CatheterFOZ2019-05-17
3268951540934893K180846Arterial Pressure Monitoring Set/TrayDQO2018-12-19
3268951784324515K180792Arterial Pressure Monitoring Set/TrayDQO2018-11-30
3268951845618347K180567C3 Wave SystemLJS2018-04-12
1597051831639130K180514VERITON NMKPS2018-04-25
685161524022149K171685Med4 EliteIRP2017-09-29
3268951377134832K163452PICC Maximal Barrier Nursing KitLJS2017-02-03
3268951624801510K163031Bunegin-Albin Air Aspiration SetDXE2017-07-27
3268951842016678K161866BioFlo Midline CatheterFOZ2016-09-08
1597051449534596K161740D-SPECT Scanner, D-SPECT L ScannerKPS2016-11-04
3268951685445116K160887Cook Intraosseous Infusion NeedlesFMI2016-07-26
3268951303970355K160223VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage CatheterNHC2016-04-08
1597051909726882K160120D-SPECT Processing and Reviewing WorkstationKPS2016-03-21
3268951082919192K152409Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICCLJS2015-09-24
3268952063036917K150448NMI PICC III and NMI PICC IVLJS2015-03-19
3268951138554533K142889Celerity PICC Tip Confirmation SystemLJS2015-01-27
1233091625695221K141583SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILYONF2014-07-22
1233091433152980K140631LUMENA FH HAIR REMOVAL SYSTEMONF2014-05-16
1233091497856998K133201SHASER V-MINI 2 HAIR REMOVAL SYSTEMONF2014-02-12
3268951171108722K121990PICC CONVENIENCE KITLJS2012-08-03
3268951070666932K121089NMI PICC IIILJS2012-08-23
1233091664962753K120080SHASER HRS2 HAIR REMOVAL SYSTEMONF2012-05-25
1597051176060975K110507CARDIAC SCANNER AND PROCESSING SYSTEMKPS2011-07-13
1233091807263659K103560SHASER IPL HAIR REMOVAL SYSTEMONF2011-05-18
3268951241265743K081113COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERSFOZ2008-07-30
685161903835378K072399DEL SOL RED LIGHT THERAPY SYSTEMILY2008-05-23
206821406230519K071616ARC SURGICAL BIOTRAK PIN SYSTEMHTY2007-12-19
808831682493618K062071PROMETEY, MODEL G1-03GEX2006-09-28
206821457581653K061763ARC SURGICAL BIOTRAK SCREWHWC2006-09-19
685161439042641K061470DEL SOL BLUE LIGHT THERAPY SYSTEMGEX2006-07-20
206821995656116K043176ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEMHWC2005-06-17
3268951322097947K033843SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATINGFOZ2004-08-12
3268951306435596K021557SPECTRUM SILICONE CATHETERFOZ2003-05-30
445781867927425
2277392055092825
206821015293476
685161023069284
206821085422567
206821145894310
206821216042491
206821288208577
206821307371214
2277391375048743
206821402594679
206821421667796
206821455183702
2277391502955590
685161512060143
206821592038107
206821674055784
206821893423072
1233091902013975
206821947919655
685161959770646
206822000812443
206822017073130
2277392027905167
685162063737601

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KPS102023-04-28
LJS92025-12-16
FOZ52019-05-17
ONF52014-07-22
FMI22025-07-30
DQO22018-12-19
GEX22006-09-28
HWC22006-09-19
ODP12024-05-30
QBD12023-02-17
LLZ12021-08-16
DTQ12019-05-24
IRP12017-09-29
DXE12017-07-27
NHC12016-04-08
ILY12008-05-23
HTY12007-12-19

NDC#

OXYGEN

Spectrum Gas Products, Inc

OXYGEN

Air

Spectrum Gas Products, Inc

Air

NITROGEN

Spectrum Gas Products, Inc

NITROGEN

Rolvedon

Spectrum Pharmaceuticals, Inc.

eflapegrastim-xnst

PMN#

VERITON NM

2018-04-25

Spectrum Dynamics Medical Ltd.

86 records. Showing 1-40. Next

Applications#

GUDID#

200 records. Showing 1-40. Next