Data / Medical devices / United States / Signa Medical, Inc.
Signa Medical, Inc.: FDA-registered device maker in Long Beach, NY, United States, 76 510(k) clearances
Signa Medical, Inc. is registered with the FDA (registration 3010419931) in Long Beach, NY, United States. It lists 72 device types. The FDA files 76 510(k) clearances under its listings, the newest dated December 16, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010419931
- Address
- 100 West Broadway Suite 7Y, Long Beach, NY, United States, 11561
- Owner or operator
- Signa Medical, Inc. (10045410)
- Roles
- Repackager or relabeler, Reprocessor, Specification developer
- First device listed
- April 2, 2024
- Registered through
- 2026
- Brand names listed
- 3M GUARD, INSTRUMENT, 3M STERI-STRIP ADHESIVE, ANOSCOPE, APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED, AUDIOSCOPE,POCKET FIBER OTOSCOPE; 777 Wall Transformer Set (including Otoscopes, Ophthalmoscope) and accessories, BD BLOOD COLLECTION,NEEDLE,TUBING, BD Vacutainer EDTA Tubes; BD Vacutainer Plus Plastic; BD Whole Blood Tube K2EDTA, BD Vacutainer Plastic Citrate Tube; Buffered Sodium Citrate Tube and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 16, 2025 | K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) | DXQ | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| October 15, 2024 | K242097 | DenMat Bulk Fill Composite | EBF | Substantially Equivalent | Den-Mat Holdings, LLC | accessdata.fda.gov |
| August 8, 2024 | K240229 | Masimo W1 | DPS | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| July 17, 2023 | K213953 | BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 24, 2023 | K220212 | BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 10, 2023 | K222478 | BD Vacutainer® Luer-Lok Access Device, BD Vacutainer® Blood Transfer Device | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| January 20, 2023 | K222462 | Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10) | KNW | Substantially Equivalent | Itp Innovative Tomography Products GmbH | accessdata.fda.gov |
| December 16, 2022 | K223243 | BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel Lancets | FMK | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| February 17, 2022 | K220137 | Lunderquist Extra Stiff Wire Guide | DQX | Substantially Equivalent | William Cook Europe Aps | accessdata.fda.gov |
| January 25, 2021 | K203453 | BD Hypodermic Syringe | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| July 30, 2020 | K201186 | KY Grosz Jelly | NUC | Substantially Equivalent | Rb Health (Us), LLC | accessdata.fda.gov |
| March 20, 2020 | K193327 | Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve | FYA | Substantially Equivalent | Cardinal Health200, LLC | accessdata.fda.gov |
| December 27, 2019 | K191059 | Masimo Rad-97 and Accessories | MWI | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| March 1, 2019 | K181730 | BD Vacutainer Eclipse UltraFill Blood Collection Needle | FMI | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| May 1, 2018 | K173035 | Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets | FGE | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| February 27, 2018 | K172044 | Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S | FGE | Substantially Equivalent | Cook Ireland, Ltd. | accessdata.fda.gov |
| December 7, 2017 | K171513 | Lunderquist Extra Stiff Wire Guide | DQX | Substantially Equivalent | William Cook Europe Aps | accessdata.fda.gov |
| November 17, 2017 | K173068 | Performer Introducer | DYB | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| March 31, 2017 | K170622 | Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component | OQY | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| December 19, 2016 | K162081 | BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| October 31, 2016 | K160450 | Pleurx Pleural Catheter System | DWM | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| June 28, 2013 | K122917 | CODA BALLOON CATHETER | DQY | Substantially Equivalent | Cook, Inc. | accessdata.fda.gov |
| January 10, 2013 | K122687 | BLOOD CULTURE HOLDER | JKA | Substantially Equivalent | Greiner Bio-One North America, Inc. | accessdata.fda.gov |
| March 23, 2012 | K120743 | SPECULUM, VAGINAL, NONMETAL | HIB | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| October 18, 2011 | K112893 | CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| June 8, 2011 | K110272 | STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| May 5, 2011 | K111185 | RELYX LUTING PLUS AUTOMIX | EMA | Substantially Equivalent | 3M Espe Dental Products | accessdata.fda.gov |
| October 21, 2010 | K101896 | MASIMO LNCS/M-LNCS OXIMETRY SENSORS | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| August 25, 2009 | K091292 | BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771 | JKA | Substantially Equivalent | Becton, Dickinson and Company (BD) | accessdata.fda.gov |
| November 20, 2007 | K072521 | COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH | FFS | Substantially Equivalent | Cook Urological, Inc. | accessdata.fda.gov |
| September 10, 2007 | K071565 | BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT | KGO | Substantially Equivalent | Molnlycke Health Care Us, LLC | accessdata.fda.gov |
| August 3, 2007 | K063835 | ALLEVYN AG DRESSING | FRO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 27, 2006 | K062438 | BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 | KNA | Substantially Equivalent | Cook Ob/Gyn | accessdata.fda.gov |
| May 31, 2006 | K061199 | ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES | JEQ | Substantially Equivalent | Braun GmbH | accessdata.fda.gov |
| April 24, 2006 | K060684 | ADPER PROMPT, ADPER PROMPT L-POP | KLE | Substantially Equivalent | 3M Espe AG Dental Products | accessdata.fda.gov |
| August 5, 2005 | K052090 | SPLASH! IMPRESSION MATERIAL DEVICE | ELW | Substantially Equivalent | Discus Dental, Inc. | accessdata.fda.gov |
| May 14, 2004 | K041071 | BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381 | JKA | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| November 13, 2003 | K032444 | NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY | LZC | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| May 9, 2003 | K030776 | MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL | ELW | Substantially Equivalent | Discus Dental, Inc. | accessdata.fda.gov |
| May 8, 2003 | K030573 | BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341 | JKA | Substantially Equivalent | Bd Vacutainer Systems Preanalyical Solutions | accessdata.fda.gov |
| November 25, 2002 | K023075 | BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE | JKA | Substantially Equivalent | Bd Vacutainer Systems Preanalyical Solutions | accessdata.fda.gov |
| September 17, 2002 | K022163 | WELCH ALLYN SPOT VITAL SIGN MONITOR WITH MP506 | DQA | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| July 19, 2002 | K021475 | BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET | FMI | Substantially Equivalent | Bd | accessdata.fda.gov |
| February 1, 2002 | K013971 | BD VACUTAINER SAFETY COAGULATION TUBE | JKA | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| December 21, 2001 | K013800 | INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| August 17, 2001 | K012455 | WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM | DXQ | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| August 14, 2000 | K000421 | BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE | KGO | Substantially Equivalent | Ssl Americas, Inc. (Regent Medical) | accessdata.fda.gov |
| August 9, 1999 | K991961 | 3M LVR SYSTEM | EBF | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| May 28, 1999 | K991088 | VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE | JKA | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| May 19, 1999 | K991120 | VACUTAINER BRAND CTAD TUBE (MULTIPLE) | JKA | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| October 28, 1998 | K982541 | VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608 | FMI | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| June 17, 1998 | K981013 | VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE | JKA | Substantially Equivalent for Some Indications | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| March 3, 1998 | K980414 | VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SET | JKA | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| November 12, 1997 | K973036 | 3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRES | MGP | Substantially Equivalent for Some Indications | 3M Healthcare | accessdata.fda.gov |
| July 14, 1997 | K963565 | MRI NEEDLES | FCG | Substantially Equivalent | Cook, Inc. | accessdata.fda.gov |
| April 9, 1997 | K970796 | 3M RED DOT 2560 & 2570 MONITORING ELECTRODES | DRX | Substantially Equivalent | 3M Healthcare | accessdata.fda.gov |
| February 10, 1997 | K965202 | VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET | JKA | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| May 14, 1996 | K960787 | TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS | LJH | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| March 28, 1996 | K960653 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED) | GAN | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| November 28, 1995 | K954592 | VACUTAINER BRAND PST PLASMA SEPARATION TUBE | JKA | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| October 7, 1995 | K951254 | SAFETYGLIDE NEEDLE | FMI | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| July 10, 1995 | K952578 | WELCH ALLY OTOSCOPE | ERA | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| January 18, 1995 | K945952 | VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBE | JKA | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| August 2, 1994 | K941272 | KLEENSPEC | HIB | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| January 28, 1993 | K925409 | ORAL-B DENTAL FLOSS WITH FLUORIDE | JES | Substantially Equivalent | Oral-B Laboratories | accessdata.fda.gov |
| November 3, 1992 | K921493 | LS100 HALOGEN EXAMINATION LIGHT, MODEL NO: 44100 | KZF | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| July 18, 1990 | K901555 | MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE | DRX | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| July 15, 1988 | K881918 | LIGHT-CURED ZIONOMER CEMENT | EMA | Substantially Equivalent | Den-Mat Corp. | accessdata.fda.gov |
| August 24, 1987 | K872510 | DEN-MAT TENURE | EBF | Substantially Equivalent | Den-Mat Corp. | accessdata.fda.gov |
| February 9, 1983 | K813265 | 3M STERI-STRIP ANTIMICROBIAL SKIN CLOS | KGX | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| July 31, 1981 | K812057 | VANCE CYSTOSCOPIC | FBK | Substantially Equivalent | Vance Products, Inc. | accessdata.fda.gov |
| June 26, 1981 | K811447 | SHILEY DISPOSABLE CANNULA TRACH. TUBE | BTO | Substantially Equivalent | Shiley, Inc. | accessdata.fda.gov |
| April 21, 1981 | K810310 | K-Y LUBRICATING JELLY | KMJ | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| February 19, 1981 | K810227 | MODEL #53110 DISPOSABLE ANOSCOPE | FER | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| May 28, 1980 | K801216 | DEN-MAT DENTIN BONDING AGENT | KLE | Substantially Equivalent | Den-Mat Corp. | accessdata.fda.gov |
| March 18, 1980 | K800485 | VINYL POLYSILOXANE IMPRESSION MATERIAL | ELW | Substantially Equivalent | 3M Company | accessdata.fda.gov |
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Updated December 16, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.