BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SIGNA MEDICAL, INC.

    Reg #: 3010419931 · FEI: 3010419931 · Expires 2026
    View on FDA
    Products
    72
    Proprietary Names
    76
    Establishment Types
    3
    Classifications
    72

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    Registration Details

    Registration Name
    SIGNA MEDICAL, INC.
    Registration Number
    3010419931
    FEI Number
    3010419931
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    100 West Broadway, Suite 7Y
    City
    Long Beach
    State
    NY
    ZIP
    11561
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160450

    Owner / Operator

    Firm Name
    Signa Medical, Inc.
    Operator Number
    10045410
    Address
    5765 GREEN POINTE DR NORTH, Suite 2
    City
    Groveport
    State
    OH
    Postal Code
    43125
    Country
    US
    Correspondent
    Erin Lohr

    Products

    Device Name Product Code
    Apparatus, Suction, Patient Care DWM
    Biopsy Needle FCG
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Agent, Tooth Bonding, Resin KLE
    Syringe, Piston FMF
    Blood Pressure Cuff DXQ
    Tube, Tracheostomy (W/Wo Connector) BTO
    Syringe, Irrigating (Non Dental) KYZ
    Guard, Instrument LXZ
    Kit, Nephroscope FGA
    Laparoscope, General & Plastic Surgery GCJ
    Ureteroscope And Accessories, Flexible/Rigid FGB
    Image, Illumination, Fiberoptic, For Endoscope FFS
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Needle, Hypodermic, Single Lumen FMI
    Stethoscope Head BZS
    Oximeter DQA
    Electrocardiograph DPS
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    Strip, Polishing Agent EHM
    Intrauterine Tamponade Balloon OQY
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Tape And Bandage, Adhesive KGX
    Set, Administration, Intravascular FPA
    Catheter, Percutaneous DQY
    System, Irrigation, Urological LJH
    Arthroscope HRX
    Instrument, Biopsy KNW
    Material, Impression ELW
    Surgeon'S Gloves KGO
    Material, Tooth Shade, Resin EBF
    Medical Glove, Specialty LZC
    Floss, Dental JES
    Anoscope And Accessories FER
    Electrode, Electrocardiograph DRX
    Dressing, Wound, Hydrophilic NAC
    Stand, Instrument, Ac-Powered, Ophthalmic HMF
    Introducer, Catheter DYB
    Dressing, Wound, Drug FRO
    Otoscope ERA
    Dressing, Wound And Burn, Occlusive MGP
    Wire, Guide, Catheter DQX
    Lubricant, Patient KMJ
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Catheter, Nephrostomy, General & Plastic Surgery GBO
    Catheter, Nephrostomy LJE
    Lubricant, Personal NUC
    Audiometer EWO
    Toothbrush, Powered JEQ
    Device, Fixation, Tracheal Tube CBH
    Cannula, Injection FGY
    Instrument, Manual, Specialized Obstetric-Gynecologic KNA
    Dressing, Compression MHW
    Cannula, Nasal, Oxygen CAT
    Gown, Surgical FYA
    Accessory, Surgical Apparel LYU
    Device, Medical Examination, Ac Powered KZF
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    Speculum, Vaginal, Nonmetal HIB
    Suture, Absorbable, Synthetic GAN
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Dressing, Wound, Occlusive NAD
    Cement, Dental EMA
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Monitor, Breathing Frequency BZQ
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide JKS
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Continuous Measurement Thermometer FLL
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK

    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 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 BD Vacutainer Plastic Citrate Tube; Buffered Sodium Citrate Tube DenMat Bulk Fill; Evanesce Bulk Fill Masimo RD SET, OXIMETER SURGEON GLOVE Dental Floss ANOSCOPE ELECTRODE WOUND DRESSING, HYDROPHILIC 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 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. 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 BECTON DICKINSON Guiding Catheter; Oasis; Pushing Catheter VAGINAL SPECULUM SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID MATERIAL, IMPRESSION BD BLOOD COLLECTION,NEEDLE,TUBING FLOSS, DENTAL Splash Max; Splash! BD Vacutainer® Push Button Blood Collection Set; BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holde MATERIAL, TOOTH SHADE, RESIN SPECULUM, VAGINAL DenMat Tenure; Tenure MPB Molnlycke, Medline Canada, Viscot, Becton dickinson Canada CEMENT, DENTAL ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY Bio-Cap; Block-Out Try-In; Duo PCH; Duo:PCH Cement; Geristore; GoldLink 2; Holistore; Infinity; Infinity SE; Lumineers SENSOR, OXIMETER

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Reprocess Single-Use Device