SPECTRUM MEDICAL IMAGING CO

Matched from indexed company URL: SPECTRUM, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2027327	2027327	SPECTRUM MEDICAL IMAGING CO	1	Y	2026-01-01	1721 Stewart St Santa Monica CA US 90404
2183967	1000115735	Spectrum Plastics Group	1	N	2026-01-01	7309 WEST 27TH ST. Saint Louis Park MN US 55426
3002672225	3002672225	SPECTRUM ASSEMBLY INC.	1	N	2026-01-01	6300 Yarrow Dr SUITE 100 Carlsbad CA US 92011
3004194034	3004194034	SPECTRUM TECHNOLOGIES	1	Y	2026-01-01	1532 CHABLIS RD. No. 101 HEALDSBURG CA US 95448
3005855240	3005855240	Spectrum Brands, Inc. (a Delaware Corporation)	1	Y	2026-01-01	3001 Deming Way Middleton WI US 53562
3006126428	3006126428	SPECTRUM MEDICAL INC	1	Y	2026-01-01	481 Munn Road, Suite 180 Fort Mill SC US 29715
3008007310	3008007310	Spectrum Dynamics Medical Inc.	1	Y	2026-01-01	301 N. Cattlemen Rd. Suite 109 Sarasota FL US 34232
3012758946	3012758946	SPECTRUM SOLUTIONS LLC	1	N	2026-01-01	12278 S Lone Peak Pkwy Ste 106 Draper UT US 84020
3030714660	3030714660	SPECTRUM VASCULAR	1	N	2026-01-01	30 Independence Blvd, Suite 120 Warren NJ US 07059
3032848631	3032848631	SPECTRUM FERTILITY GROUP	1	Y	2026-01-01	867 Boylston Street, 5th Floor -#1984 Boston MA US 02116
3036496433	3036496433	SPECTRUM SPINE INC	1	N	2026-01-01	20 Harmony Ct Jasper GA US 30143
2028306	1000125318	SPECTRUM DESIGNS, INC.	1	N	2020-04-25	132 Easy St. Unit D5 Buellton CA US 93427
3006015832	3006015832	Spectrum International, Inc.	1	N	2020-04-25	2401 Stanwell Drive, Suite 340 Concord CA US 94520
3007611821	3007611821	Spectrum Aeromed LLC	1	Y	2020-04-25	1815 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 GUDID	Product	Phone	Email
00850301007020	Wolf - "Sterile Equipment Drape, ENDOCAM Camera, 7""X96^"""	+1(214)492-0506	hfahrlander@spectrumlabs.com
00850301007808	Spectrum, Inc. - Specimine Container, 16 Oz, Sterile	+1(214)492-0506	hfahrlander@spectrumlabs.com
00850301007860	Spectrum, Inc. - "Strap-Stroll Stockinette, 4"" X 3', Sterile"	+1(214)492-0506	hfahrlander@spectrumlabs.com
00850301007877	Spectrum, Inc. - "Strap-Stroll Stockinette, 4"" X 4 ', Sterile"	+1(214)492-0506	hfahrlander@spectrumlabs.com
00855495007344	Spectrum, Inc. - "Sterile Equipment Drape, ESS Universal Camera Drape, 7"" X 96"", Latex Free"	+1(214)492-0506	hfahrlander@spectrumlabs.com
00855495007351	Spectrum, Inc. - "Sterile Equipment Drape, 12"" X 100"" w/Bag Clip, Latex Free"	+1(214)492-0506	hfahrlander@spectrumlabs.com
00855495007368	Spectrum, Inc. - "Sterile Equipment Drape, AssistArm Surgical Drape, 7"" X 96"", Latex Free"	+1(214)492-0506	hfahrlander@spectrumlabs.com
00855495007382	Spectrum, Inc. - "Sterile Equipment Drape, Microlase, 5"" X 59"", latex Free"	+1(214)492-0506	hfahrlander@spectrumlabs.com

spectrumlabs.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
326895	1885000864	K963097	CLAMPLESS VALVED CATHETER-PICC (CVC-PICC)	LJS	1996-10-18
326895	1117167607	K252373	BioFlo 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 Technology	LJS	2025-12-16
326895	1693824114	K250724	Intraosseous Infusion Needles	FMI	2025-07-30
337879	1883987665	K240838	Spectrum Spine Cervical Cage System	ODP	2024-05-30
159705	1147052839	K230600	VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)	KPS	2023-04-28
227739	1856890584	K223497	Spectrum Saliva Collection Device	QBD	2023-02-17
159705	1111926954	K212230	TruSPECT Radiological Image Processing Station	LLZ	2021-08-16
159705	1348968376	K190457	VERITON CT whole body SPECT/CT system	KPS	2019-07-12
88728	1042567990	K190282	Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)	DTQ	2019-05-24
159705	1004438678	K182484	VERITON CT whole body SPECT/CT system	KPS	2018-11-09
326895	1545658736	K182252	Cook Unimpregnated Central Venous Catheter	FOZ	2019-05-17
326895	1540934893	K180846	Arterial Pressure Monitoring Set/Tray	DQO	2018-12-19
326895	1784324515	K180792	Arterial Pressure Monitoring Set/Tray	DQO	2018-11-30
326895	1845618347	K180567	C3 Wave System	LJS	2018-04-12
159705	1831639130	K180514	VERITON NM	KPS	2018-04-25
68516	1524022149	K171685	Med4 Elite	IRP	2017-09-29
326895	1377134832	K163452	PICC Maximal Barrier Nursing Kit	LJS	2017-02-03
326895	1624801510	K163031	Bunegin-Albin Air Aspiration Set	DXE	2017-07-27
326895	1842016678	K161866	BioFlo Midline Catheter	FOZ	2016-09-08
159705	1449534596	K161740	D-SPECT Scanner, D-SPECT L Scanner	KPS	2016-11-04
326895	1685445116	K160887	Cook Intraosseous Infusion Needles	FMI	2016-07-26
326895	1303970355	K160223	VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter	NHC	2016-04-08
159705	1909726882	K160120	D-SPECT Processing and Reviewing Workstation	KPS	2016-03-21
326895	1082919192	K152409	Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC	LJS	2015-09-24
326895	2063036917	K150448	NMI PICC III and NMI PICC IV	LJS	2015-03-19
326895	1138554533	K142889	Celerity PICC Tip Confirmation System	LJS	2015-01-27
123309	1625695221	K141583	SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILY	ONF	2014-07-22
123309	1433152980	K140631	LUMENA FH HAIR REMOVAL SYSTEM	ONF	2014-05-16
123309	1497856998	K133201	SHASER V-MINI 2 HAIR REMOVAL SYSTEM	ONF	2014-02-12
326895	1171108722	K121990	PICC CONVENIENCE KIT	LJS	2012-08-03
326895	1070666932	K121089	NMI PICC III	LJS	2012-08-23
123309	1664962753	K120080	SHASER HRS2 HAIR REMOVAL SYSTEM	ONF	2012-05-25
159705	1176060975	K110507	CARDIAC SCANNER AND PROCESSING SYSTEM	KPS	2011-07-13
123309	1807263659	K103560	SHASER IPL HAIR REMOVAL SYSTEM	ONF	2011-05-18
326895	1241265743	K081113	COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS	FOZ	2008-07-30
68516	1903835378	K072399	DEL SOL RED LIGHT THERAPY SYSTEM	ILY	2008-05-23
20682	1406230519	K071616	ARC SURGICAL BIOTRAK PIN SYSTEM	HTY	2007-12-19
80883	1682493618	K062071	PROMETEY, MODEL G1-03	GEX	2006-09-28
20682	1457581653	K061763	ARC SURGICAL BIOTRAK SCREW	HWC	2006-09-19
68516	1439042641	K061470	DEL SOL BLUE LIGHT THERAPY SYSTEM	GEX	2006-07-20
20682	1995656116	K043176	ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM	HWC	2005-06-17
326895	1322097947	K033843	SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING	FOZ	2004-08-12
326895	1306435596	K021557	SPECTRUM SILICONE CATHETER	FOZ	2003-05-30
44578	1867927425
227739	2055092825
20682	1015293476
68516	1023069284
20682	1085422567
20682	1145894310
20682	1216042491
20682	1288208577
20682	1307371214
227739	1375048743
20682	1402594679
20682	1421667796
20682	1455183702
68516	1482957674
227739	1502955590
68516	1512060143
20682	1592038107
20682	1674055784
68516	1768585516
20682	1893423072
123309	1902013975
20682	1947919655
68516	1959770646
20682	2000812443
20682	2017073130
227739	2027905167
68516	2063737601

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
KPS	10	2023-04-28
LJS	9	2025-12-16
FOZ	5	2019-05-17
ONF	5	2014-07-22
FMI	2	2025-07-30
DQO	2	2018-12-19
GEX	2	2006-09-28
HWC	2	2006-09-19
ODP	1	2024-05-30
QBD	1	2023-02-17
LLZ	1	2021-08-16
DTQ	1	2019-05-24
IRP	1	2017-09-29
DXE	1	2017-07-27
NHC	1	2016-04-08
ILY	1	2008-05-23
HTY	1	2007-12-19

NDC#

OXYGEN
Spectrum Gas Products, Inc
OXYGEN
Air
Spectrum Gas Products, Inc
Air
NITROGEN
Spectrum Gas Products, Inc
NITROGEN
NITROUS OXIDE
Spectrum Gas Products, Inc
NITROUS OXIDE
Rolvedon
Spectrum Pharmaceuticals, Inc.
eflapegrastim-xnst
Stay AgelessTinted Sunscreen Broad Spectrum SPF 30
Spectrum Aesthetics Laser Training LLC
Titanium Dioxide and Zinc Oxide

PMN#

Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System
2026-03-30
Spectrum Spine
Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W
2026-03-12
Spectrum Medical S.R.L.
Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)
2025-08-04
Spectrum Medical S.R.L.
Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)
2025-07-08
Spectrum Medical , Ltd.
Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)
2025-06-24
Spectrum Medical S.R.L.
SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter
2024-11-27
Spectrum Vascular
Quantum Perfusion Hybrid System
2024-07-18
Spectrum Medical S.R.L.
Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)
2024-05-31
Spectrum Medical S.R.L.
Spectrum Spine Cervical Cage System
2024-05-30
Spectrum Spine, Inc.
VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)
2023-04-28
Spectrum Dynamics Medical, Ltd.
Spectrum Saliva Collection Device
2023-02-17
Spectrum Solutions, LLC
Spectricept Skin and Wound Cleanser
2023-01-13
Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.
Quantum Heater-Cooler
2022-05-06
Spectrum Medical Ltd.
TruSPECT Radiological Image Processing Station
2021-08-16
Spectrum Dynamics Medical, Ltd.
Quantum Mini Ventilation Module
2021-05-04
Spectrum Medical Ltd.
Expandable Titanium PLIF/TLIF System
2021-04-29
Spectrum Spine, LLC
Quantum Ventilation Module
2020-10-16
Spectrum Medical Ltd
Quantum Workstation 12 Elite
2020-10-02
Spectrum Medical Ltd
Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure
2020-04-13
Spectrum Medical Ltd
VERITON CT Whole Body SPECT/CT System
2019-07-12
Spectrum Dynamics Medical Ltd
Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)
2019-05-24
Spectrum Medical Ltd
Spectrum Spine Expandable Cages (SSEC)
2019-03-07
Spectrum Spine, LLC
VERITON CT Whole Body SPECT/CT System
2018-11-09
Spectrum Dynamics Medical Ltd
Quantum Ventilation Module
2018-10-18
Spectrum Medical Ltd
Quantum Workstation 12.1
2018-08-17
Spectrum Medical Ltd
Quantum Pump Console
2018-05-25
Spectrum Medical Ltd
VERITON NM
2018-04-25
Spectrum Dynamics Medical Ltd.
Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas
2018-03-28
Spectrum Medical Ltd
Quantum Workstation
2017-01-18
Spectrum Medical Ltd
D-SPECT Scanner, D-SPECT L Scanner
2016-11-04
Spectrum Dynamics Medical Ltd
D-SPECT Processing And Reviewing Workstation
2016-03-21
SPECTRUM DYNAMICS LTD.
SPECTRUM SPINE SPINOUS PROCESS DEVICE
2013-11-12
SPECTRUM SPINE IP HOLDINGS, LLC
SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM
2013-10-28
SPECTRUM SPINE, LLC
SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM
2013-02-07
SPECTRUM SPINE, LLC
INSULATION TESTER
2012-03-27
SPECTRUM SURGICAL SUPPLY CORP.
CARDIAC SCANNER AND PROCESSING SYSTEM
2011-07-13
SPECTRUM DYNAMICS (ISRAEL) LTD.
M4 MONITOR
2011-05-31
SPECTRUM MEDICAL, LLP
M3 MONITOR
2009-07-10
SPECTRUM MEDICAL LTD
MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM
2007-10-01
SPECTRUM DYNAMICS LTD.
M3 MONITOR
2007-08-17
SPECTRUM MEDICAL LTD

86 records. Showing 1-40. Next

Applications#

761148
SPECTRUM PHARMS
205752
SPECTRUM PHARMS
125019
SPECTRUM PHARMS
087792
SPECTRUM PHARMS
012209
SPECTRUM PHARMS

GUDID#

Wolf - "Sterile Equipment Drape, ENDOCAM Camera, 7""X96^"""
SPECTRUM, INC.
2017-01-30
Spectrum, Inc. - Specimine Container, 16 Oz, Sterile
SPECTRUM, INC.
2017-07-21
Spectrum, Inc. - "Sterile Equipment Drape, ESS Universal Camera Drape, 7"" X 96"", Latex Free"
SPECTRUM, INC.
2017-07-21
Spectrum, Inc. - "Sterile Equipment Drape, 12"" X 100"" w/Bag Clip, Latex Free"
SPECTRUM, INC.
2017-07-21
Spectrum, Inc. - "Sterile Equipment Drape, AssistArm Surgical Drape, 7"" X 96"", Latex Free"
SPECTRUM, INC.
2017-07-21
Spectrum, Inc. - "Sterile Equipment Drape, Microlase, 5"" X 59"", latex Free"
SPECTRUM, INC.
2017-07-21
Spectrum, Inc. - "Strap-Stroll Stockinette, 4"" X 3', Sterile"
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - "Strap-Stroll Stockinette, 4"" X 4 ', Sterile"
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - "Strap-Stroll Stockinette, 6"" X 4', Sterile"
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - "Strap-Stroll Stockinette, 6"" X 5', Sterile"
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - "Strap-Stroll Stockinette, 6"" X 6', Sterile"
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - "Strap-Stroll Stockinette, 8"" X 5', Sterile"
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - "Strap-Stroll Stockinette, 8"" X 6', Sterile"
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - "2 Ply Stockinette, 50/50, 2"" X 4', Sterile"
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - "2 Ply Stockinette, 50/50, 3"" X 3', Sterile"
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - "2 Ply Stockinette, 50/50, 3"" X 4', Sterile"
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - "2 Ply Stockinette, 50/50, 4"" x 3', Sterile"
SPECTRUM, INC.
2017-02-14
Richard WOLF - "2 Ply Stockinette, 50/50, 4"" X 4', Sterile"
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - "2 Ply Stockinette, 50/50, 4"" X5', Sterile"
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - "2 Ply Stockinette, 50/50, 4"" X 6', Sterile"
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - "2 Ply Stockinette, 50/50, 6"" X 3', Sterile"
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - "2 Ply Stockinette, 50/50, 6"" X 4', Sterile"
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - "2 Ply Stockinette, 50/50 ,6"" X 4.5', Sterile"
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - "2 Ply Stockinette, 50/50, 6"" X 5', Sterile"
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - "2 Ply Stockinette, 50/50, 6"" X 6', Sterile"
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - "2 Ply Stockinette, 50/50, 8"" X 6', Sterile"
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - "2 Ply Stockinette, 50/50, 8"" X 5', Sterile"
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - Hy'N Dry Stockinette, Impervious,Arms/Legs, Small, Sterile
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - Hy'N Dry Stockinette, Impervious, Hips/Legs Regular, Sterile
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - Hy'N Dry Stockinette, Impervious, Hips/Legs Large, Sterile
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - "Hy'N Dry Stockinette, Impervious, 8""X 4' with straps, Sterile"
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - "Hy'N Dry Stockinette, Impervious, 10"" X 4', with straps, Sterile"
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - "Hy'N Dry Stockinette, Impervious, 12"" X 5' with straps, Sterile"
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - "Stockinette, Bulk, 50/50 Blend Tubular, 2"" x 25 Yards, Non-sterile"
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - "Stockinette, Bulk, 50/50 Blend Tubular, 3"" x 25 Yards, Non-sterile"
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - "Stockinette, Bulk, 50/50 Blend Tubular, 4"" x 25 Yards, Non-sterile"
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - "Stockinette, Bulk, 50/50 Blend Tubular,6"" x 25 Yards, Non-sterile"
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - "Stockinette, Bulk, 50/50 Blend Tubular, 8"" x 25 Yards, Non-sterile"
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - "Stockinette- 50/50% - Bias, 3"" X 4 Yards - Sterile"
SPECTRUM, INC.
2017-02-14
Spectrum, Inc. - "Stockinette- 50/50% - Bias, 4"" X 3 Yards - Sterile"
SPECTRUM, INC.
2017-02-14

200 records. Showing 1-40. Next