SPECTRA MEDICAL DEVICES, LLC

FDA Registration(s)#

Registered Device Listings#

Product Codes Associated With Registrations#

NDC#

• Sodium Chloride

  Spectra Medical Deviecs, LLC

  Sodium Chloride

• Sodium Chloride

  Spectra Medical Deviecs, LLC

  Sodium Chloride

• Lidocaine Hydrochloride

  Spectra Medical Devices, LLC

  LIDOCAINE HYDROCHLORIDE ANHYDROUS

• NUMSTAT Antiseptic and Pain Relieving Prep Pad

  Spectra Medical Devices, LLC

  alcohol, menthol, and benzocaine prep pad

• 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

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...

• Glidelight Laser Sheath

  2021-09-02

  Spectranetics (Philips)

• AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating

  2021-07-27

  SPECTRANETICS CORP.

• ELCA Coronary Atherectomy Catheter

  2021-05-11

  SPECTRANETICS CORP.

• Spectranetics CVX-300 Excimer Laser System

  2020-12-22

  SPECTRANETICS CORP.

• AngioSculpt PTCA Scoring Balloon Catheter, AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating

  2020-09-21

  SPECTRANETICS CORP.

• SLS/GlideLight

  2020-05-06

  SPECTRANETICS CORP.

• Spectranetics Laser Sheaths SLS

  2019-10-21

  SPECTRANETICS CORP.

• CVX-3000 Excimer Lasert System and ELCA Coronary Atherectomy Catheters

  2019-10-21

  SPECTRANETICS CORP.

• SLS/GlideLight

  2019-10-07

  SPECTRANETICS CORP.

• AngioSculpt PTCA Scoring Balloon Catheter

  2019-08-22

  SPECTRANETICS CORP.

• Spectranetics Laser Sheath (SLS) II and GlideLight Laser Sheath

  2019-06-28

  SPECTRANETICS CORP.

• CVX-300 Excimer Laser System and ELCA Coronary Atherectomy Catheters

  2019-03-20

  SPECTRANETICS CORP.

• SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM

  2018-11-16

  SPECTRANETICS CORP.

• Spectranetics Laser Sheaths SLS

  2018-11-16

  SPECTRANETICS CORP.

• CVX-300 Excimer Laser System and ELCA Coronary Atherectomy Catheters

  2018-10-15

  SPECTRANETICS CORP.

• AngioSculpt PTCA Scoring Balloon Catheter

  2018-10-15

  SPECTRANETICS CORP.

• Spectranetics Laser Sheaths SLS

  2018-10-15

  SPECTRANETICS CORP.

• CVX-300 and CVX-300-P Excimer Laser Systems

  2018-09-25

  SPECTRANETICS CORP.

• ELCA Coronary Atherectomy Catheters

  2018-08-14

  SPECTRANETICS CORP.

• SLS ll/GlideLight Catheters

  2018-08-14

  SPECTRANETICS CORP.

• CVX-300 and CVX-300-P EXCIMER LASER SYSTEM

  2018-07-27

  SPECTRANETICS CORP.

• CVX-300-P Excimer Laser System

  2018-06-29

  SPECTRANETICS CORP.

• SLS II/GlideLight catheters

  2018-06-28

  SPECTRANETICS CORP.

• SLS II/Glide Light Catheters

  2018-05-31

  SPECTRANETICS CORP.

• CVX-300 Excimer Laser System/ELCA Coronary Atherectomy Catheter

  2018-05-08

  SPECTRANETICS CORP.

• Spectranetics Laser Sheaths SLS (SLS ll/GlideLight)

  2018-05-08

  SPECTRANETICS CORP.

• ELCA Laser Catheters

  2018-03-29

  SPECTRANETICS CORP.

• CVX-300 Excimer Laser System

  2017-12-22

  SPECTRANETICS CORP.

• ELCA Coronary Laser Atherectomy Catheters

  2017-09-21

  SPECTRANETICS CORP.

• ELCA Coronary Laser Atherectomy Catheters

  2017-09-01

  SPECTRANETICS CORP.

• ELCA Laser Catheters

  2017-08-25

  SPECTRANETICS CORP.

• ELCA Catheters

  2017-08-22

  SPECTRANETICS CORP.

• Spectranetics Laser Sheath II (SLS II) GlideLight Catheters

  2017-07-31

  SPECTRANETICS CORP.

• ELCA

  2017-07-18

  SPECTRANETICS CORP.

• SLS / GlideLight

  2017-07-18

  SPECTRANETICS CORP.

• Spectranetics CVX-300 Exclimer Laser System

  2017-07-07

  SPECTRANETICS CORP.

200 records. Showing 1-40. Next

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.

• SpectoMed (v1.0)

  2025-01-14

  Specto Medical

• 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.

• HyperVue? Imaging System

  2023-06-07

  Spectrawave, 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.

• SpectraWAVE Imaging System

  2023-02-28

  Spectrawave, Inc.

• 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.

• TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013)

  2022-12-15

  Spectranetics, Inc.

• Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters

  2022-12-08

  Spectranetics Inc.

• MRI Planner

  2022-08-25

  Spectronic Medical AB

• TightRail Guardian Motorized Dilator Sheath

  2022-08-24

  Spectranetics, 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

• Bridge Occlusion Balloon

  2020-12-23

  Spectranetics, Inc.

• 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

• T-Stat 2.0 Microvascular Tissue Oximeter

  2019-09-23

  Spectros Corporation

• 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

• Endotoxin Activity Assay (EAA)

  2019-03-12

  Spectral Medical Inc.

• 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.

• Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters

  2018-04-05

  Spectranetics, Inc.

• Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas

  2018-03-28

  Spectrum Medical Ltd

• SAM CRRT Unit, SAM Cassette CRRT

  2017-12-13

  Spectral Medical Inc.

195 records. Showing 1-40. Next

Applications#

• 761148

  SPECTRUM PHARMS

• 208017

  SPECTRA MDCL DEVICES

• 206171

  SPECTRA MDCL DEVICES

• 205752

  SPECTRUM PHARMS

• 204455

  SPECTRON MRC LLC

• 203912

  SPECTRON MRC LLC

• 203911

  SPECTRON MRC LLC

• 125019

  SPECTRUM PHARMS

• 087792

  SPECTRUM PHARMS

• 012209

  SPECTRUM PHARMS

GUDID#

• MSK Ultrasonic Injection Needle - 21G TW x 4.00" MSK Ultrasonic Injection Needle, C-Bevel, Echo Dimpling, No Marks, Green Hub, Lubricated, Extruded Protector with Extension Set

  Spectra Medical Devices, LLC

  2024-02-12

• MSK Ultrasonic Injection Needle - 21G TW x 2.00" MSK Ultrasonic Injection Needle, C-Bevel, Echo Dimpling, No Marks, Green Hub, Lubricated, Molded Protector with Extension Set

  Spectra Medical Devices, LLC

  2024-02-12

• MSK Ultrasonic Injection Needle - 22G TW x 6.00" MSK Ultrasonic Injection Needle, C-Bevel, Echo Dimpling, Marks, Black Hub, Lubricated, Extruded Protector with Extension Set

  Spectra Medical Devices, LLC

  2024-06-18

• MSK Ultrasonic Injection Needle - 23G TW x 2.00" MSK Ultrasonic Injection Needle, C-Bevel, Echo Dimpling, No Marks, Blue Hub, Lubricated, Molded Protector without Extension Set

  Spectra Medical Devices, LLC

  2024-06-18

• MSK Ultrasonic Injection Needle - 22G TW x 2.00" MSK Ultrasonic Injection Needle, C-Bevel, Echo Dimpling, No Marks, Black Hub, Lubricated, Molded Protector with Extension Set

  Spectra Medical Devices, LLC

  2024-06-18

• MSK Ultrasonic Injection Needle - 21G TW x 6.00" MSK Ultrasonic Injection Needle, C-Bevel, Echo Dimpling, No Marks, Green Hub, Lubricated, Extruded Protector with Extension Set

  Spectra Medical Devices, LLC

  2024-06-18

• Plastic BD Style Hub Tuohy Epidural Needle - Plastic BD Style Hub Tuohy Epidural Needle, 18G Special x 5.00" Plastic Stylet, Marks, No Wing, Luer Connector

  Spectra Medical Devices, LLC

  2024-06-18

• Plastic BD Style Hub Tuohy Epidural Needle - Plastic BD Style Hub Tuohy Epidural Needle, 18G Special x 3.50", Plastic Stylet, Marks, No Wing, Luer Connector

  Spectra Medical Devices, LLC

  2024-06-18

• Plastic BD Style Hub Tuohy Epidural Needle - Plastic BD Style Hub Tuohy Epidural Needle, 17G Special x 3.50", Plastic Stylet, Marks, No Wing, NRFit Connector

  Spectra Medical Devices, LLC

  2024-06-18

• Endotoxin Activity Assay (EAA) - The EAA™ is a rapid in vitro diagnostic test that utilizes a specific monoclonal antibody to measure the endotoxin activity in EDTA whole blood specimens.

  Spectral Medical Inc

  2018-01-09

• Smart Line TL Tube Luminometer - Smart Line TL Tube Luminometer is a stand-alone instrument with a built-in microprocessor software. Three softkeys and the <esc> key are all you need to operate the luminometer. Menus and parameters for functions that are not automated, are selected via these softkeys. The display shows the menu items, the actionsperformed and the user prompts.The luminometer includes an internal reading device for chip cards. Measurement protocols are saved on this chip card. During this procedure the user is prompted step by step to place the required tubes into the instrument for measurement. This ensures a high level of automation and standardization of the measurement process.

  Spectral Medical Inc

  2019-03-14

• 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

• Radiofrequency (RF) Needle - 22G x 10cm x 10mm Active Tip, Sharp RF Needle, No Echogenic Tip, Lubrication, Straight, Black Cap

  Spectra Medical Devices, LLC

  2024-06-18

• Radiofrequency (RF) Needle - 22G x 10cm x 5mm Active Tip, Sharp RF Needle, No Echogenic Tip, Lubrication, Straight, Black Cap

  Spectra Medical Devices, LLC

  2024-06-18

• Radiofrequency (RF) Needle - 22G x 5cm x 10mm Active Tip, Sharp RF Needle, No Echogenic Tip, Lubrication, Straight, Black Cap

  Spectra Medical Devices, LLC

  2024-06-18

• Radiofrequency (RF) Needle - 22G x 5cm x 4mm Active Tip, Sharp RF Needle, No Echogenic Tip, Lubrication, Straight, Black Cap

  Spectra Medical Devices, LLC

  2024-06-18

• Radiofrequency (RF) Needle - 21G x 10cm x 10mm Active Tip, Sharp RF Needle, Echogenic Tip, No Lubrication, Straight, Green Cap

  Spectra Medical Devices, LLC

  2024-06-18

• Radiofrequency (RF) Needle - 21G x 5cm x 5mm Active Tip, Sharp RF Needle, Echogenic Tip, No Lubrication, Straight, Green Cap

  Spectra Medical Devices, LLC

  2024-06-18

• Radiofrequency (RF) Needle - 21G x 5cm x 4mm Active Tip, Sharp RF Needle, No Echogenic Tip & Lubrication, Straight, Green Cap

  Spectra Medical Devices, LLC

  2024-06-18

• Radiofrequency (RF) Needle - 20G x 15cm x 20mm Active Tip, Sharp RF Needle, No Echogenic Tip & Lubrication, Straight, Yellow Cap

  Spectra Medical Devices, LLC

  2024-06-18

• Radiofrequency (RF) Needle - 20G x 15cm x 15mm Active Tip, Sharp RF Needle, No Echogenic Tip & Lubrication, Straight, Yellow Cap

  Spectra Medical Devices, LLC

  2024-06-18

• Radiofrequency (RF) Needle - 20G x 15cm x 10mm Active Tip, Sharp RF Needle, No Echogenic Tip, Lubrication, Straight, Yellow Cap

  Spectra Medical Devices, LLC

  2024-06-18

• Radiofrequency (RF) Needle - 20G x 10cm x 10mm Active TipSharp RF Needle, No Echogenic Tip, LubricationStraight, Yellow Cap

  Spectra Medical Devices, LLC

  2024-06-18

• Radiofrequency (RF) Needle - 18G x 15cm x 10mm Active Tip,Sharp RF Needle, No Echogenic Tip & Lubrication, Straight, Pink Cap

  Spectra Medical Devices, LLC

  2024-06-18

• Radiofrequency (RF) Needle - 18G x 15cm x 5mm Active Tip, Sharp RF Needle, No Echogenic Tip & Lubrication, Straight, Pink Cap

  Spectra Medical Devices, LLC

  2024-06-18

• Radiofrequency (RF) Needle - 18G 10cm x 10mm Active Tip, Sharp RF Needle, No Echogenic Tip & Lubrication, Straight, Pink Cap

  Spectra Medical Devices, LLC

  2024-06-18

• Radiofrequency (RF) Needle - 18G x 10cm x 5mm Active Tip, Sharp RF Needle, No Echogenic Tip, Lubrication, Straight, Pink Cap

  Spectra Medical Devices, LLC

  2024-06-18

• Radiofrequency (RF) Needle - 22G x 10cm x 10mm Active TipSharp RF Needle, No Echogenic Tip, LubricationCurved, Black Cap

  Spectra Medical Devices, LLC

  2024-06-18

• Radiofrequency (RF) Needle - 22G x 10cm x 5mm Active TipSharp RF Needle, No Echogenic Tip, LubricationCurved, Black Cap

  Spectra Medical Devices, LLC

  2024-06-18

• Radiofrequency (RF) Needle - 22G x 5cm x 10mm Active TipSharp RF Needle, No Echogenic Tip, LubricationCurved, Black Cap

  Spectra Medical Devices, LLC

  2024-06-18

• Radiofrequency (RF) Needle - 22G x 5cm x 5mm Active Tip, Sharp RF Needle, No Echogenic Tip, Lubrication, Curved, Black Cap

  Spectra Medical Devices, LLC

  2024-06-18

• Radiofrequency (RF) Needle - 20G x 15cm x 15mm Active Tip, Sharp RF Needle, No Echogenic Tip & Lubrication, Curved, Yellow Cap

  Spectra Medical Devices, LLC

  2024-06-18

• Radiofrequency (RF) Needle - 20G x 15cm x 10mm Active TipSharp RF Needle, No Echogenic Tip, LubricationCurved, Yellow Cap

  Spectra Medical Devices, LLC

  2024-06-18

• Radiofrequency (RF) Needle - 20G x 15cm x 5mm Active Tip, Sharp RF Needle, No Echogenic Tip & Lubrication,Curved, Yellow Cap

  Spectra Medical Devices, LLC

  2024-06-18

• Radiofrequency (RF) Needle - 20G x 10cm x 5mm Active Tip, Sharp RF Needle, No Echogenic Tip & Lubrication, Curved, Yellow Cap

  Spectra Medical Devices, LLC

  2024-06-18

• Radiofrequency (RF) Needle - 18G x 15cm x 5mm Active Tip, Sharp RF Needle, No Echogenic Tip, Lubrication, Curved, Pink Cap

  Spectra Medical Devices, LLC

  2024-06-18

• Metal Standard Hub Tuohy Epidural Needle - "Metal Standard Hub Tuohy Epidural Needle, 18G x 3.50"", Marks"

  Spectra Medical Devices, LLC

  2024-06-18

• Metal Standard Hub Tuohy Epidural Needle - "Metal Standard Hub Tuohy Epidural Needle, 17G x 6.00"", Marks"

  Spectra Medical Devices, LLC

  2024-06-18

• Metal Standard Hub Tuohy Epidural Needle - "Metal Standard Hub Tuohy Epidural Needle, 17G x 5.00"", Marks"

  Spectra Medical Devices, LLC

  2024-06-18

80 records. Showing 1-40. Next