FDA.reportPublic FDA data

SPECTRA MEDICAL DEVICES, LLC

Matched from indexed company URL: Spect Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12249603000204727SPECTRA MEDICAL DEVICES, LLC1Y2026-01-01299 Ballardvale St Ste 1 WILMINGTON MA US 01887
15287641000136007SPECTRAMED, LLC1Y2026-01-01275 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
30049572063004957206SPECTROS MEDICAL DEVICES INC1N2026-01-012211 Norfolk St #1110 Houston TX US 77098
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
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

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
00850083596002LaserWrap - A-10 Slim Impulse Laser Unit with USB Cord and Charger for use with LASERwrap accessories. LASERwrap® is a wearable cold laser therapy device that consists of a small impulse laser unit that transmits light through filaments into a pad or wrap. The pad or wrap is applied to almost any part of the body, helping both human and animals. This type of therapy is also known as low level laser therapy, LLLT, or cold laser therapy.1-248-321-2029JohnStephan@SpectraTherapy.com
00850083596026LaserWrap - A-100 Impulse Laser Unit with USB Cord and Battery Charger for use with LASERwrap accessories. LASERwrap® is a wearable cold laser therapy device that consists of a small impulse laser unit that transmits light through filaments into a pad or wrap. The pad or wrap is applied to almost any part of the body, helping both humans and animals. This type of therapy is also known as low-level laser therapy, LLLT, or cold laser therapy. The A-100 is a Class 1M Diode Laser with a wavelength of 660nm (Non-IR).1-248-321-2029JohnStephan@SpectraTherapy.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
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
3516301615674118K253101HyperVue™ Imaging System - IntegratedNQQ2025-12-15
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
3516301669208952K251355X1-FFRQHA2025-10-17
3516301674097433K251198HyperVue™ SoftwareNQQ2025-07-16
3034391838702748K251198HyperVue™ SoftwareNQQ2025-07-16
3268951693824114K250724Intraosseous Infusion NeedlesFMI2025-07-30
2246111474511468K250385Turbo-Elite Laser Atherectomy CatheterMCW2025-03-13
3034391635364408K243016Starlight Imaging CatheterNQQ2025-03-20
3516301660846489K243016Starlight Imaging CatheterNQQ2025-03-20
3516301331025868K230691HyperVue™ Imaging SystemNQQ2023-06-07
3034391639363244K230691HyperVue™ Imaging SystemNQQ2023-06-07
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
3516301905960488K221257SpectraWAVE 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
633042060326010K192322T-Stat 2.0 Microvascular Tissue OximeterMUD2019-09-23
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
633041650809977K081233T-STAT 303 ISCHEMIA MONITORING SYSTEMMUD2008-07-28
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

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MCW162025-03-13
NQQ102025-12-15
KPS102023-04-28
LJS92025-12-16
DQY72015-02-27
MUD62019-09-23
DRE62016-07-08
FOZ52019-05-17
ONF52014-07-22
BSP42017-09-08
FMI32025-07-30
MJN32025-06-24
DRB32014-08-12
IPF32013-02-07
ILY32008-07-09
PDU32007-07-11
QHA22025-10-17
NGS22019-03-12
DQO22018-12-19
DYB22012-03-21
QEZ22008-03-28
HWC22006-09-19
LHQ22003-10-10
SHY12026-05-21
QBD12023-02-17
MUJ12022-08-25
QRJ12021-12-21
LLZ12021-08-16
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

NDC#

PMA#

200 records. Showing 1-40. Next

PMN#

195 records. Showing 1-40. Next

Applications#

GUDID#

80 records. Showing 1-40. Next