Spectra Medical Devices Inc

FDA Filings

This page includes the latest FDA filings for Spectra Medical Devices Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Spectra Medical Devices Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• AILEE CO., LTD.
• KEVIN WALLS
• SUNG LIM INDUSTRIES, CO., LTD.
• HUONS CO., LTD.
• Agustin Turriza
• ANTHONY C. ARRIGO

FDA Registration(s)

• Registration Number: 1224960
• FEI Number: 3000204727
• Name: SPECTRA MEDICAL DEVICES, INC.
• Owner & Operator: SPECTRA MEDICAL DEVICES
• Contact Address: 260-F FORDHAM ROAD --; Wilmington MA 01887 US
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 260H Fordham Rd ; WILMINGTON, MA 01887 US
• Establishment Type:
  • Repack or Relabel Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
Lidocaine Hydrochloride Spectra Medical Devices, LLC, Delta Synthetic Co., Ltd., Huons Co., Ltd.	Prescription Medication	2024-01-13
Sodium Chloride Spectra Medical Deviecs, LLC, Spectra Medical Devices, LLC, Huons Co., Ltd.	Prescription Medication	2024-01-13
Lidocaine Hydrochloride Spectra Medical Devices, LLC, Delta Synthetic Co., Ltd., Huons Co., Ltd.	Prescription Medication	2022-12-17
Sodium Chloride Spectra Medical Deviecs, LLC, Spectra Medical Devices, LLC, Huons Co., Ltd.	Prescription Medication	2022-12-17
Lidocaine Hydrochloride Spectra Medical Devices, LLC, Delta Synthetic Co., Ltd., Huons Co., Ltd.	Prescription Medication	2021-12-01
Sodium Chloride Spectra Medical Deviecs, LLC, Spectra Medical Devices, LLC, Huons Co., Ltd.	Prescription Medication	2021-12-01
Lidocaine Hydrochloride Spectra Medical Devices, LLC, Delta Synthetic Co., Ltd., Huons Co., Ltd.	Prescription Medication	2021-11-19
Sodium Chloride Spectra Medical Deviecs, LLC, Spectra Medical Devices, LLC, Huons Co., Ltd.	Prescription Medication	2021-10-28
Sodium Chloride Spectra Medical Deviecs, LLC, Spectra Medical Devices, LLC, Huons Co., Ltd.	Prescription Medication	2021-01-12
Lidocaine Hydrochloride Spectra Medical Devices, LLC, Delta Synthetic Co., Ltd., Huons Co., Ltd.	Prescription Medication	2020-06-04
A3820-18 CONTINUOUS EPIDURAL 18G HUSTEAD Smiths Medical ASD, Inc., Hospira, Inc., Spectra Medical Devices, Inc.	Other Medication	2020-03-12
Lidocaine Hydrochloride Spectra Medical Devices, LLC, Delta Synthetic Co., Ltd., Huons Co., Ltd.	Prescription Medication	2019-11-19
Sodium Chloride Spectra Medical Deviecs, LLC, Spectra Medical Devices, LLC, Huons Co., Ltd.	Prescription Medication	2019-11-19
Lidocaine Hydrochloride Spectra Medical Devices, LLC, Delta Synthetic Co., Ltd., Huons Co., Ltd.	Prescription Medication	2019-04-21
Sodium Chloride Spectra Medical Deviecs, LLC, Spectra Medical Devices, LLC, Huons Co., Ltd.	Prescription Medication	2019-04-12
NDC 65282-1605 Spectra Medical Devices, Inc.	Lidocaine Hydrochloride	2018-04-18
PMN K163292 | BSP SPECTRA MEDICAL DEVICES, INC. [SPECTRA MEDICAL DEVICES]	SPECTRA Sonic Block Tuohy Needle	2017-12-27
PMN K163292 | BSP SPECTRA MEDICAL DEVICES, INC. [SPECTRA MEDICAL DEVICES]	SPECTRA Sonic Block Quincke Needle	2017-12-27
PMN K163292 | BSP SPECTRA MEDICAL DEVICES, INC. [SPECTRA MEDICAL DEVICES]	SPECTRA Sonic Block Crawford Needle	2017-12-27
PMN K163292 | BSP SPECTRA MEDICAL DEVICES, INC. [SPECTRA MEDICAL DEVICES]	SPECTRA Sonic Block Chiba Needle	2017-12-27
NDC 65282-1510 Spectra Medical Devices, Inc.	Sodium Chloride	2017-07-21
NDC 65282-1505 Spectra Medical Devices, Inc.	Sodium Chloride	2017-07-21
PMN K151069 | BSP SPECTRA MEDICAL DEVICES, INC. [SPECTRA MEDICAL DEVICES]	SPECTRA MSK Ultrasonic Injection Needle	2016-02-06
PMN K151069 | BSP SPECTRA MEDICAL DEVICES, INC. [SPECTRA MEDICAL DEVICES]	SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle	2016-02-06
PMN K151069 SPECTRA MEDICAL DEVICES, INC.	SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle	2016-02-05
PMN K142791 | KNW SPECTRA MEDICAL DEVICES, INC. [SPECTRA MEDICAL DEVICES]	Spectra Soft Tissue Biopsy Needles	2015-01-26
A3820-18 CONTINUOUS EPIDURAL 18G HUSTEAD Smiths Medical ASD, Inc., Hospira, Inc., Spectra Medical Devices, Inc.	Other Medication	2014-04-08
GDX SPECTRA MEDICAL DEVICES, INC. [SPECTRA MEDICAL DEVICES]	Disposable Scalpel, One-Piece, Non-Sterile	2012-03-10
KXF SPECTRA MEDICAL DEVICES, INC. [SPECTRA MEDICAL DEVICES]	Sponge Applicator	2011-09-20
PMN K103740 SPECTRA MEDICAL DEVICES, INC.	SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE	2011-07-29
PMN K091462 | GES SPECTRA MEDICAL DEVICES, INC. [SPECTRA MEDICAL DEVICES]	Spectra Safety Scalpel	2009-12-18
PMN K091462 | GES SPECTRA MEDICAL DEVICES, INC. [SPECTRA MEDICAL DEVICES]	Spectra Safe-Cut Safety Scalpel	2009-12-18
PMN K091462 | GDZ SPECTRA MEDICAL DEVICES, INC. [SPECTRA MEDICAL DEVICES]	Spectra Safety Scalpel	2009-12-18
PMN K091462 | GDZ SPECTRA MEDICAL DEVICES, INC. [SPECTRA MEDICAL DEVICES]	Spectra Safe-Cut Safety Scalpel	2009-12-18
PMN K000117 | HEE SPECTRA MEDICAL DEVICES, INC. [SPECTRA MEDICAL DEVICES]	Cervical Regional Anesthesia Needle	2009-12-18
PMN K082689 SPECTRA MEDICAL DEVICES, INC.	STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE	2009-03-20
PMN K082674 | FMF SPECTRA MEDICAL DEVICES, INC. [SPECTRA MEDICAL DEVICES]	Glass LOR Syringe	2008-12-15
PMN K082580 | DYB SPECTRA MEDICAL DEVICES, INC. [SPECTRA MEDICAL DEVICES]	Spectra Guidewire Introducer Needle	2008-12-15
PMN K082580 SPECTRA MEDICAL DEVICES, INC.	SPECTRA GUIDEWIRE INTRODUCER NEEDLE	2008-12-08
PMN K082674 SPECTRA MEDICAL DEVICES, INC.	SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE	2008-11-28
PMN K081524 SPECTRA MEDICAL DEVICES, INC.	SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L	2008-07-29
PMN K971645 | MIA SPECTRA MEDICAL DEVICES, INC. [SPECTRA MEDICAL DEVICES]	Spinal Needles (various)	2008-06-09
PMN K971645 | MIA SPECTRA MEDICAL DEVICES, INC. [SPECTRA MEDICAL DEVICES]	Spectra Spinal Needles	2008-06-09
PMN K945965 | BSP SPECTRA MEDICAL DEVICES, INC. [SPECTRA MEDICAL DEVICES]	Atraumatic Pencil Point Spinal Needle	2008-06-09
PMN K891226 | FPA SPECTRA MEDICAL DEVICES, INC. [SPECTRA MEDICAL DEVICES]	Vascular Access Port Infusion Set	2008-06-09
PMN K884792 | FMI SPECTRA MEDICAL DEVICES, INC. [SPECTRA MEDICAL DEVICES]	Vascular Access Port Huber Point Infusion Needle	2008-06-09
PMN K880181 | CAZ SPECTRA MEDICAL DEVICES, INC. [SPECTRA MEDICAL DEVICES]	Disposable Epidural Anesthesia Tray	2008-06-09
PMN K854816 | BSP SPECTRA MEDICAL DEVICES, INC. [SPECTRA MEDICAL DEVICES]	Spectra Epidural Needles	2008-06-09
PMN K854816 | BSP SPECTRA MEDICAL DEVICES, INC. [SPECTRA MEDICAL DEVICES]	Epidural Anesthesia Needle	2008-06-09
PMN K032196 | GXI SPECTRA MEDICAL DEVICES, INC. [SPECTRA MEDICAL DEVICES]	SPECTRA Disposable Radio Frequency (RF) Needle	2008-06-09
PMN K032196 | GXI SPECTRA MEDICAL DEVICES, INC. [SPECTRA MEDICAL DEVICES]	NBD Disposable RF Cannula	2008-06-09
PMN K032196 | GXD SPECTRA MEDICAL DEVICES, INC. [SPECTRA MEDICAL DEVICES]	SPECTRA Disposable Radio Frequency (RF) Needle	2008-06-09
PMN K032196 | GXD SPECTRA MEDICAL DEVICES, INC. [SPECTRA MEDICAL DEVICES]	NBD Disposable RF Cannula	2008-06-09
MDM SPECTRA MEDICAL DEVICES, INC. [SPECTRA MEDICAL DEVICES]	Instrument,Manual,Surgical, General	2008-05-13

Similar & Related FDA Registered Companies

• Spectra Medical Devices, LLC
• Delta Synthetic Co., Ltd.
• Huons Co., Ltd.
• Spectra Medical Deviecs, LLC
• Smiths Medical ASD, Inc.
• Hospira, Inc.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092818668	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	SPONGE	92 CTN
2020092818670	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	CANNULA AND STYLET COMPONENTS	1 PKG
2020092818669	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	FOAM POUCH	100 CTN
2020092273467	Pusan,South Korea -> New York, New York	SPONGE	67 CTN
2020092273468	Pusan,South Korea -> New York, New York	FOAM POUCH	100 CTN
2020092231414	Nhava Sheva,India -> New York/Newark Area, Newark, New Jersey	TROCARS, TUNNELERS	42 PKG
2020092119782	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	SPONGE	96 CTN
2020091761235	Nhava Sheva,India -> New York/Newark Area, Newark, New Jersey	TROCARS, TUNNELERS	42 PKG