FDA.report

SPECTRA MEDICAL DEVICES, LLC

Matched from indexed company URL: Spect Inc.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
12249603000204727SPECTRA MEDICAL DEVICES, LLC1Y2026-01-01299 Ballardvale St Ste 1 WILMINGTON MA US 01887
15287641000136007SPECTRAMED, LLC1N2026-01-01275 W Johnstown Rd Gahanna OH US 43230
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
96178573000058367Spectral Medical Inc.1N2026-01-01135 The West Mall, Unit 2 TORONTO Ontario CA M9C 1C2
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
30054620463005462046SPECTRANETICS CORP.1N2026-01-015055 BRANDIN COURT FREMONT CA US 94538
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
30070109033007010903SPECTRON IR1N2026-01-01841 W Stewart Ave Ste 9 Medford OR US 97501
30072840063007284006SPECTRANETICS CORP.1N2026-01-019965 Federal Drive Colorado Springs CO US 80921
30080073103008007310Spectrum Dynamics Medical Inc.1Y2026-01-01301 N. Cattlemen Rd. Suite 109 Sarasota FL US 34232
30085392453008539245SPECTRA THERAPY LLC1N2026-01-013350 Lapeer Rd Port Huron MI US 48060
30091728453009172845SPECTACLES SRL1N2026-01-01Via s. Tommaso D'Aquino, 32 ROma IT 00136
30095488403009548840Spectra Baby USA1Y2026-01-013430 Davie Rd. Suite 306 Davie FL US 33314
30110505413011050541SPECTRAL MD, INC.1N2026-01-012515 McKinney Ave Ste 1000 Dallas TX US 75201
30127589463012758946SPECTRUM SOLUTIONS LLC1N2026-01-0112278 S Lone Peak Pkwy Ste 106 Draper UT US 84020
30176542473017654247SPECTRAWAVE, INC.1N2026-01-0112 Oak Park Drive Bedford MA US 01730
30253099243025309924SPECTRONIC MEDICAL AB1N2026-01-01Karbingatan 36 Helsingborg Skane SE 25467
30304124173030412417SPECTRA RED LIGHT LLC1N2026-01-01531 Maple St Millerstown PA US 17062
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
30381363203038136320SPECTO MEDICAL AG1N2026-01-01Elisabethenstrasse 18 Basel Basel-Stadt CH 4051

GUDID Contact Samples

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

Source GUDIDProductPhoneEmail
05060434420831Quantum - Quantum Micro-Cardioplegia Delivery Module+441242650120eusales@spectrummedical.com
05060434424457Quantum - QPF8+441242650120eusales@spectrummedical.com
05060434424532Quantum - Quantum Pump Frame 9 - Mirandola+441242650120eusales@spectrummedical.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2246111522896006P960042SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATHMFA1997-12-09
2246111502892847P910001SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEMLPC1993-02-19
2246201235096327P050018ANGIOSCULPT SCORING BALLOON CATHETERNWX2007-01-08
2246111798403434K990713SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTERDRB1999-10-22
155691298660587K971645REGANES SPINAL NEEDLE (VARIOUS)MIA1997-08-01
3268951885000864K963097CLAMPLESS VALVED CATHETER-PICC (CVC-PICC)LJS1996-10-18
155691608695873K945965ATRAUMATIC PENCIL POINT SPINAL NEEDLEBSP1995-08-02
155691223470358K891226VASCULAR ACCESS PORT CONTINUOUS INFUSION SETFPA1989-05-30
155691375371123K884792VASCULAR ACCESS PORT HUBER POINT INFUSION NEEDLESFMI1989-01-30
155691435579951K880181REGANES DISPOSABLE EPIDURAL ANESTHESIA TRAYCAZ1988-02-11
155691570108064K854816EPIDURAL ANESTHESIA NEEDLESBSP1985-12-19
3034391781284821K253101HyperVue™ Imaging System - IntegratedNQQ2025-12-15
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
2246111669709004K251358Bridge Plus Occlusion Balloon (590-002)MJN2025-06-24
3034391045591926K251355X1-FFRQHA2025-10-17
3034391838702748K251198HyperVue™ SoftwareNQQ2025-07-16
3268951693824114K250724Intraosseous Infusion NeedlesFMI2025-07-30
2246111474511468K250385Turbo-Elite Laser Atherectomy CatheterMCW2025-03-13
3034391635364408K243016Starlight Imaging CatheterNQQ2025-03-20
3381551580071158K242205SpectoMed (v1.0)LLZ2025-01-14
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
2246111271538768K222837Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy CathetersMCW2022-12-08
3034391663224876K221257SpectraWAVE Imaging SystemNQQ2023-02-28
1597051111926954K212230TruSPECT Radiological Image Processing StationLLZ2021-08-16
3114621224440089K211841MRI PlannerMUJ2022-08-25
2246112049161027K2115182.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy SystemMCW2021-06-14
2246111974618367K203540Bridge Occlusion BalloonMJN2020-12-23
1597051348968376K190457VERITON CT whole body SPECT/CT systemKPS2019-07-12
887281042567990K190282Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)DTQ2019-05-24
179401396612317K183176Endotoxin Activity Assay (EAA)NGS2019-03-12
2246111285971218K182972Phoenix Atherectomy SystemMCW2018-12-20
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
2246111636344723K180694Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy CathetersMCW2018-04-05
3268951845618347K180567C3 Wave SystemLJS2018-04-12
1597051831639130K180514VERITON NMKPS2018-04-25
2246111906292186K172687Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy CathetersMCW2017-11-27
2246111837534181K1723861.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy SystemMCW2017-08-24
685161524022149K171685Med4 EliteIRP2017-09-29
2246111973813442K170059Spectranetics Turbo-Elite Laser Atherectomy CathetersMCW2017-04-07
3268951377134832K163452PICC Maximal Barrier Nursing KitLJS2017-02-03
155691421779550K163292Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block CrawfordBSP2017-09-08
3268951624801510K163031Bunegin-Albin Air Aspiration SetDXE2017-07-27
2246111618755378K162561Turbo-Power (2.0mm) Laser Atherectomy CathetersMCW2017-01-05
3268951842016678K161866BioFlo Midline CatheterFOZ2016-09-08
1597051449534596K161740D-SPECT Scanner, D-SPECT L ScannerKPS2016-11-04
2246111594804055K161333TightRail Sub-C Rotating Dilator SheathDRE2016-07-08
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
2246111176873756K153530Bridge Occlusion BalloonMJN2016-02-05
3268951082919192K152409Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICCLJS2015-09-24
2246111383490492K152181Turbo-Power Laser Atherectomy CatheterMCW2015-11-12
2246111084096469K1511452.4mm X 127 cm Phoenix Atherectomy Deflecting SystemMCW2015-05-26
155691804111067K151069SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction NeedleBSP2016-02-05
2246201427274688K150634AngioSculpt PTA Scoring Baloon CathetersPNO2015-04-08
3268952063036917K150448NMI PICC III and NMI PICC IVLJS2015-03-19
2246111918271890K150360TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator SheathDRE2015-03-04
2246111242407941K150201Quick-Cross Extreme Support Catheter, Quick-Cross Select Support CatheterDQY2015-02-27
2246111923581339K1433281.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support ClipMCW2014-12-19
3268951138554533K142889Celerity PICC Tip Confirmation SystemLJS2015-01-27
155691407552940K142791Spectra Soft Tissue Biopsy NeedlesKNW2015-01-21
2246111087530227K142116LLD EZDRB2014-08-12
1233091625695221K141583SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILYONF2014-07-22
2246111088493979K141131TIGHTRAIL MINIDRE2014-05-23
2246111867817755K1409441.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIPMCW2014-08-22
2246111615950423K140775TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEMMCW2014-07-23
1233091433152980K140631LUMENA FH HAIR REMOVAL SYSTEMONF2014-05-16
2246111394774547K140047LEXICONTURE MECHANICAL DILATOR SHEATH SETDRE2014-04-09
2246111376833177K133631LEXIPLIANT DILATOR SHEATH SETDRE2014-03-27
1233091497856998K133201SHASER V-MINI 2 HAIR REMOVAL SYSTEMONF2014-02-12
2246111498845986K1236322.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035MCW2013-01-25
3268951171108722K121990PICC CONVENIENCE KITLJS2012-08-03
3268951070666932K121089NMI PICC IIILJS2012-08-23
2246111975572961K120964UPSTREAM GR CATHETERDQY2012-05-25
465642027211004K120922GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNITIPF2013-02-07
1233091664962753K120080SHASER HRS2 HAIR REMOVAL SYSTEMONF2012-05-25
2246111365517418K112887UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTORDYB2012-03-21
2246111195165916K1120328FR TURBO - TANDEM SYSTEMDQY2011-10-17
1597051176060975K110507CARDIAC SCANNER AND PROCESSING SYSTEMKPS2011-07-13
155691268355923K103740SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULENGT2011-07-29
1233091807263659K103560SHASER IPL HAIR REMOVAL SYSTEMONF2011-05-18
2246111070003896K094036TURBO-TANDEM SYSTEM MODEL 472-110MCW2010-01-25
2246111670667973K093257TORQMAX SHEATH GRIP ACCESSORYOFC2010-03-26
2246111398980328K092396SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERSDQY2009-09-04
2246111835953734K092378SPECTRANETICS VISISHEATH DILATOR SHEATHDRE2009-11-02
155691612871682K091462SPECTRA MEDICAL SAFETY SCAPELGDZ2009-12-15
155691080824440K082674SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGEFMF2008-11-28
155692002024595K082580SPECTRA GUIDEWIRE INTRODUCER NEEDLEDYB2008-12-08
3268951241265743K081113COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERSFOZ2008-07-30
1887881515890245K080689SPECTRA THERAPY SYSTEM A1000 LASER DEVICEILY2008-07-09
2246111097788854K080144MANDREL GUIDEWIRES OR M-WIRESDQX2008-02-26
2246111943788147K073519QUICKCAT EXTRACTION CATHETER, MODEL 60090-01QEZ2008-03-28
2246111552573170K072750SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066DQY2007-12-04
685161903835378K072399DEL SOL RED LIGHT THERAPY SYSTEMILY2008-05-23
206821406230519K071616ARC SURGICAL BIOTRAK PIN SYSTEMHTY2007-12-19
2246111494339827K071227CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15PDU2007-07-11
2246111200248551K0712268FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043PDU2007-06-29
206821457581653K061763ARC SURGICAL BIOTRAK SCREWHWC2006-09-19
685161439042641K061470DEL SOL BLUE LIGHT THERAPY SYSTEMGEX2006-07-20
2246111031587048K060092QUICKCAT EXTRACTION CATHETERQEZ2006-03-09
2246111395671332K060012CLIRPATH TURBO PERIPHERAL CATHETERSPDU2006-09-29
2246111788081296K043401SPECTRANETICS LLD CS, MODEL 518-039DRB2005-03-16
206821995656116K043176ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEMHWC2005-06-17
3268951322097947K033843SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATINGFOZ2004-08-12
2246111488924645K033678SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034, 518-035, 518-036, 518-037 AND 518-038DQY2004-02-23
1011731197075278K032471TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEMLHQ2003-10-10
155691842070445K032196NBD DISPOSABLE RF CANNULAEGXI2003-10-09
1011731390496558K023434DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEMLHQ2002-11-14
465641299021659K023036CARE ETSIPF2003-06-19
2246111742476424K022138SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028DQY2002-09-23
3268951306435596K021557SPECTRUM SILICONE CATHETERFOZ2003-05-30

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
MCW162025-03-13
KPS102023-04-28
LJS92025-12-16
DQY72015-02-27
DRE62016-07-08
FOZ52019-05-17
ONF52014-07-22
NQQ42025-12-15
BSP42017-09-08
FMI32025-07-30
MJN32025-06-24
DRB32014-08-12
IPF32013-02-07
ILY32008-07-09
PDU32007-07-11
LLZ22025-01-14
NGS22019-03-12
DQO22018-12-19
DYB22012-03-21
QEZ22008-03-28
HWC22006-09-19
LHQ22003-10-10
QHA12025-10-17
ODP12024-05-30
QBD12023-02-17
MUJ12022-08-25
QRJ12021-12-21
DTQ12019-05-24
IRP12017-09-29
DXE12017-07-27
NHC12016-04-08
PNO12015-04-08
KNW12015-01-21
NGT12011-07-29
OFC12010-03-26
GDZ12009-12-15
FMF12008-11-28
DQX12008-02-26
HTY12007-12-19
NWX12007-01-08

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

PMA

ELCA Coronary Laser Catheters

2022-10-21

SPECTRANETICS CORP.9965 Federal Drivecolorado Springs, CO 80921 PMA NumberP910001 Supplement NumberS117 Date Received09/23/2022 Decision Date10/21/2022 Product Code LPC  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Proces...

ELCA Coronoary Laser Atherectomy Catheter

2022-08-19

SPECTRANETICS CORP.9965 Federal Drivecolorado Springs, CO 80921 PMA NumberP910001 Supplement NumberS116 Date Received06/17/2022 Decision Date08/19/2022 Product Code LPC  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Pr...

Philips Laser System

2022-05-05

SPECTRANETICS CORP.9965 Federal Drivecolorado Springs, CO 80921 PMA NumberP910001 Supplement NumberS115 Date Received02/23/2022 Decision Date05/05/2022 Product Code LPC  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Ch...

ELCA Coronary Atherectomy Catheters

2022-02-24

SPECTRANETICS CORP.9965 Federal Drivecolorado Springs, CO 80921 PMA NumberP910001 Supplement NumberS114 Date Received02/14/2022 Decision Date02/24/2022 Product Code LPC  Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement R...

ELCA

2017-07-18

SPECTRANETICS CORP.

200 records. Showing 1-40. Next

PMN

VERITON NM

2018-04-25

Spectrum Dynamics Medical Ltd.

195 records. Showing 1-40. Next

Applications

GUDID

SpectoMED - SpectoMed provides real-time spatial-visualization of medical imaging allowing the manipulation, processing, review, analysis, communication and media interchange of multi-dimensional digital images of several modalities as defined by the DICOM standard, such as CT or MRI imaging datasets. Furthermore, SpectoMed aids the clinician in the preparation of a surgical intervention with measurements and import of compatible objects within the realistic spatial visuals of the patient’s anatomy as well as their intraoperative display. SpectoMed is intended as an aid for assessing patient images.

Specto Medical AG

2025-03-31

Sirius 2 Tube Luminometer - The Sirius 2 Tube Luminometer is a highly sensitive and compact stand-alone single tube luminometer. The touchscreen on the control unit is all that is needed to operate the luminometer. Menus and parameters for functions that are not automated, are selected via the touchscreen on the control unit. The display shows the menu items, the actions performed, and the user prompts. The luminometer is capable of reading USB keys. Measurement protocols may be saved on USB keys. During a procedure, the user is prompted step-by-step to place the required tubes into the instrument for measurement. This ensures the standardization of the measurement process. The Sirius 2 is designed for the detection of chemi- and bioluminescence.

Spectral Medical Inc

2025-03-21

81 records. Showing 1-40. Next