Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010419931

FEI Number

3010419931

Entity Name

SIGNA MEDICAL, INC.

City/State/Country

Long Beach, NY, US

Establishment Address

100 West Broadway, Suite 7Y, Long Beach, NY 11561, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Signa Medical, Inc. (Owner Number: 10045410)

Owner / Operator Contact Address

5765 GREEN POINTE DR NORTH, Suite 2, Groveport, OH 43125, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K223243

PMA Number

N/A

All Registered Proprietary Names

SUCTION APPARATUS BIOPSY NEEDLE BD Vacutainer® Trace Element K2EDTA Tubes; BD Vacutainer® Trace Element Serum Tubes TOOTH BONDING AGENT SYRINGE PISTON, NEEDLE, HYPODERMIC BP CUFFS (FLEXIPORT) TRACHEOSTOMY TUBE NASAL ASPIRTATOR 3M GUARD, INSTRUMENT FLEXOR VISION URETEROSCOPE AND ACCESSORIES Needle, Hypodermic, Single Lumen Stethoscope, Acoustic MASIMO OXIMETER Denmat Ceri-Sander Intrauterine tamponade balloon APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED Medline Canada, Viscot, Becton dickinson Canada Tubes, Vials, Systems, Serum Separators, Blood Collection 3M STERI-STRIP ADHESIVE SET, ADMINISTRATION, INTRAVASCULAR CTAD Tube Catheter, Percutaneous, Introducer SYSTEM, IRRIGATION, UROLOGICAL BD Vacutainer® Luer-Lok Access Device, BD Vacutainer® Blood Transfer Device SYRINGE PISTON, NEEDLE, HYPODERMIC BondLink; Gloss 'N' Seal; LumiBrite Desensitizing Enhancer; Tenure Quik with Fluoride; Tenure S; Tenure Uni-Bond SEMI AUTOMATIC BIOPSY NEEDLE Chocolate Bite; Clear Bite; Mega Bite; Vanilla Bite Medline Canada, Viscot, Becton dickinson Canada BD Vacutainer Plastic Citrate Tube; Buffered Sodium Citrate Tube Medline Canada, Viscot, Becton dickinson Canada Tubes, Vials, Systems, Serum Separators, Blood Collection Medline Canada, Viscot, Becton dickinson Canada DenMat Bulk Fill; Evanesce Bulk Fill Masimo RD SET, OXIMETER SURGEON GLOVE Dental Floss ANOSCOPE ELECTRODE WOUND DRESSING, HYDROPHILIC Needle, Hypodermic, Single Lumen OPTHO/OTOSCOPE NON-POWERED INTRODUCER, CATHETER DRESSING, WOUND, DRUG Welch Allyn LED Otoscope; Welch Allyn LumiView Clear Single-Use Ear Specula; BP Cuff- Durashock Sphygmomanometers, Accessories BD Vacutainer Rapid Serum Tube Plus ELECTRODE DC Wire Guides; Lunderquist® Extra Stiff Wire Guide KY LUBRICATING JELLY CATHETER, NEPHROSTOMY BD Vacutainer SST Tubes LUBRICANT, PERSONAL AUDIOSCOPE,POCKET FIBER OTOSCOPE; 777 Wall Transformer Set (including Otoscopes, Ophthalmoscope) and accessories TOOTHBRUSH, POWERED ENDOTRACHEAL TUBE HOLDER DEVICE FIXATION CAREFUSION 2200, INC. Tubes, Vials, Systems, Serum Separators, Blood Collection POSTPARTUM BALLOON DRESSING, COMPRESSION NASAL CANNULA TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION BD Vacutainer EDTA Tubes; BD Vacutainer Plus Plastic; BD Whole Blood Tube K2EDTA tubes, vials, systems, serum separators, blood collection SURGICAL ACCESSORY MEDICAL SPECIALTY GLOVE HALOGEN EXAMINATION LIGHT Tubes, Vials, Systems, Serum Separators, Blood Collection BECTON DICKINSON

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DWM	Apparatus, Suction, Patient Care	Cardiovascular	Class 2	870.5050	2025-04-17
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2025-08-07
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-01-21
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2025-05-07
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-04-23
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2026-02-03
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2025-04-17
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2025-04-17
LXZ	Guard, Instrument	General, Plastic Surgery	Class 1	878.4800	2025-01-15
FGA	Kit, Nephroscope	Gastroenterology, Urology	Class 2	876.1500	2025-12-12
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-12-12
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-12-12
FFS	Image, Illumination, Fiberoptic, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2025-12-12
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2025-12-12
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-12-12
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2025-01-21
BZS	Stethoscope Head	Anesthesiology	Class 1	868.1930	2026-02-03
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2026-01-06
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2026-01-06
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2026-01-06
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2025-01-10
OQY	Intrauterine Tamponade Balloon	Obstetrics/Gynecology	Class 2	884.4530	2025-12-12
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2025-04-17
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2024-12-27
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-01-21
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2025-08-26
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-04-25
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-01-21
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-12-12
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2025-04-23
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2025-04-23
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-01-21
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-09-08
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2025-01-15
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2025-08-07
ELW	Material, Impression	Dental	Class 2	872.3660	2025-01-15
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2024-12-27
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-12-27
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-12-27
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-01-21
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2024-12-27
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-01-21
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-12-27
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2025-01-10
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2025-12-22
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2025-04-17
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2025-04-17
JES	Floss, Dental	Dental	Class 1	872.6390	2024-07-15
FER	Anoscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2025-04-17
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2025-04-17
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2025-04-17
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2025-01-21
HMF	Stand, Instrument, Ac-Powered, Ophthalmic	Ophthalmic	Class 1	886.1860	2026-03-02
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-08-07
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2025-08-26
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2026-02-03
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2026-03-02
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-01-21
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2025-04-17
MGP	Dressing, Wound And Burn, Occlusive	Unknown	Class U	N/A	2024-04-02
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-08-07
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2025-09-11
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2025-08-07
GBO	Catheter, Nephrostomy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2025-08-07
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2025-08-07
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-01-21
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2025-09-26
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2026-03-02
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2025-09-11
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2025-04-17
FGY	Cannula, Injection	General, Plastic Surgery	Class 1	878.4200	2024-12-26
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-01-21
KNA	Instrument, Manual, Specialized Obstetric-Gynecologic	Obstetrics/Gynecology	Class 2	884.4530	2025-11-10
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2025-01-21
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2025-04-17
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-04-25
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-01-21
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-01-21
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-04-17
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2025-04-17
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2025-04-17
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2026-02-03
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-01-21
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-01-21
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2024-12-27

Official Correspondent

Erin Lohr

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Signa Medical, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K160450	Care Fusion	Pleurx Pleural Catheter System	2016-10-31
K150891	Covidien, LLC( Formerly Beacon Endoscopic Corp.)	BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System	2015-05-01
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22
K020499	Jeneric/Pentron, Inc.	BOND-3 ADHESIVE	2002-04-22
K801093	Dentsply Intl.	PRISMA-BOND	1980-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2012	Olympus America Inc.	2	OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010419931. Last updated year: 2026. Please use registration number 3010419931 when referencing this establishment in official correspondence.