FDA.reportPublic FDA data

SIGNA MEDICAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30104199313010419931SIGNA MEDICAL, INC.1Y2026-01-01100 West Broadway Suite 7Y Long Beach NY US 11561

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1642371702796307K9919613M LVR SYSTEMEBF1999-08-09
1642371300666268K991120VACUTAINER BRAND CTAD TUBE (MULTIPLE)JKA1999-05-19
1642371313970863K991088VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLEJKA1999-05-28
1642371226029334K982541VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608FMI1998-10-28
1642371992345339K981013VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBEJKA1998-06-17
1642371996531922K980414VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SETJKA1998-03-03
1642371515816708K9730363M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRESMGP1997-11-12
1642371309415478K9707963M RED DOT 2560 & 2570 MONITORING ELECTRODESDRX1997-04-09
1642371877610718K965202VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SETJKA1997-02-10
1642371033439904K963565MRI NEEDLESFCG1997-07-14
1642371702868830K960787TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETSLJH1996-05-14
1642371372065421K960653MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)GAN1996-03-28
1642371654388612K954592VACUTAINER BRAND PST PLASMA SEPARATION TUBEJKA1995-11-28
1642371012412227K952578WELCH ALLY OTOSCOPEERA1995-07-10
1642372026378674K951254SAFETYGLIDE NEEDLEFMI1995-10-07
1642371262594690K945952VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBEJKA1995-01-18
1642371960255142K941272KLEENSPECHIB1994-08-02
1642371627429366K925409ORAL-B DENTAL FLOSS WITH FLUORIDEJES1993-01-28
1642371308223533K921493LS100 HALOGEN EXAMINATION LIGHT, MODEL NO: 44100KZF1992-11-03
1642371818558512K901555MODEL 1730 NEOTRODE WITH ATTACHED LEADWIREDRX1990-07-18
1642371257997101K881918LIGHT-CURED ZIONOMER CEMENTEMA1988-07-15
1642371436118274K872510DEN-MAT TENUREEBF1987-08-24
1642371603252758K8132653M STERI-STRIP ANTIMICROBIAL SKIN CLOSKGX1983-02-09
1642371168899815K812057VANCE CYSTOSCOPICFBK1981-07-31
1642371905365988K811447SHILEY DISPOSABLE CANNULA TRACH. TUBEBTO1981-06-26
1642371130963556K810310K-Y LUBRICATING JELLYKMJ1981-04-21
1642371823390329K810227MODEL #53110 DISPOSABLE ANOSCOPEFER1981-02-19
1642371054459684K801216DEN-MAT DENTIN BONDING AGENTKLE1980-05-28
1642371656899638K800485VINYL POLYSILOXANE IMPRESSION MATERIALELW1980-03-18
1642371188992559K251745Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)DXQ2025-12-16
1642371583708450K242097DenMat Bulk Fill CompositeEBF2024-10-15
1642371683393176K240229Masimo W1DPS2024-08-08
1642371056223724K223243BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel™ LancetsFMK2022-12-16
1642371296857117K222478BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer DeviceJKA2023-03-10
1642371627455058K222462Semi-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)KNW2023-01-20
1642371448941437K220212BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached HolderJKA2023-03-24
1642371698711174K220137Lunderquist Extra Stiff Wire GuideDQX2022-02-17
1642371485342096K213953BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum TubesJKA2023-07-17
1642371769528360K203453BD Hypodermic SyringeFMF2021-01-25
1642371696161879K201186KY Grosz JellyNUC2020-07-30
1642371432349779K193327Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage SleeveFYA2020-03-20
1642371931267387K191059Masimo Rad-97 and AccessoriesMWI2019-12-27
1642371827139112K181730BD Vacutainer Eclipse UltraFill Blood Collection NeedleFMI2019-03-01
1642371808329488K173068Performer IntroducerDYB2017-11-17
1642371131212274K173035Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and SetsFGE2018-05-01
1642371463995858K172044Cotton-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 SFGE2018-02-27
1642371856250451K171513Lunderquist Extra Stiff Wire GuideDQX2017-12-07
1642371183704571K170622Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation ComponentOQY2017-03-31
1642371744894669K162081BD 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 SyringeFMF2016-12-19
1642371441330973K160450Pleurx Pleural Catheter SystemDWM2016-10-31
1642371718626355K122917CODA BALLOON CATHETERDQY2013-06-28
1642371306297375K122687BLOOD CULTURE HOLDERJKA2013-01-10
1642371105713826K120743SPECULUM, VAGINAL, NONMETALHIB2012-03-23
1642371083857261K112893CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETSFPA2011-10-18
1642371080266156K111185RELYX LUTING PLUS AUTOMIXEMA2011-05-05
1642371101068197K110272STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGKGO2011-06-08
1642371567920737K101896MASIMO LNCS/M-LNCS OXIMETRY SENSORSDQA2010-10-21
1642371682974996K091292BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771JKA2009-08-25
1642371873744100K072521COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATHFFS2007-11-20
1642371634867502K071565BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENTKGO2007-09-10
1642371098527578K063835ALLEVYN AG DRESSINGFRO2007-08-03
1642371347738233K062438BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500KNA2006-10-27
1642371550228109K061199ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIESJEQ2006-05-31
1642371660326402K060684ADPER PROMPT, ADPER PROMPT L-POPKLE2006-04-24
1642371681550873K052090SPLASH! IMPRESSION MATERIAL DEVICEELW2005-08-05
1642371439327103K041071BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381JKA2004-05-14
1642371020707261K032444NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPYLZC2003-11-13
1642371286283383K030776MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIALELW2003-05-09
1642371909315240K030573BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341JKA2003-05-08
1642371609249726K023075BD VACUTAINER PLUS SST SERUM SEPARATOR TUBEJKA2002-11-25
1642371801758119K022163WELCH ALLYN SPOT VITAL SIGN MONITOR WITH MP506DQA2002-09-17
1642371494839134K021475BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SETFMI2002-07-19
1642371050919629K013971BD VACUTAINER SAFETY COAGULATION TUBEJKA2002-02-01
1642371681757821K013800INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETEFOZ2001-12-21
1642371727005019K012455WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEMDXQ2001-08-17
1642371370985237K000421BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVEKGO2000-08-14
1642371313634023BK050036
1642371041269090
1642371066713407
1642371128175042
1642371222649833
1642371005015540
1642371027493507
1642371061622438
1642371173707541
1642371306830884
1642371308351494
1642371322318099
1642371370133329
1642371457448872
1642371532724932
1642371717687854
1642371788754310
1642371925089412
1642371974689854

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JKA162023-07-17
FMI42019-03-01
EBF32024-10-15
KGO32011-06-08
ELW32005-08-05
DXQ22025-12-16
DQX22022-02-17
FMF22021-01-25
FGE22018-05-01
HIB22012-03-23
EMA22011-05-05
DQA22010-10-21
KLE22006-04-24
DRX21997-04-09
DPS12024-08-08
KNW12023-01-20
FMK12022-12-16
NUC12020-07-30
FYA12020-03-20
MWI12019-12-27
DYB12017-11-17
OQY12017-03-31
DWM12016-10-31
DQY12013-06-28
FPA12011-10-18
FFS12007-11-20
FRO12007-08-03
KNA12006-10-27
JEQ12006-05-31
LZC12003-11-13
FOZ12001-12-21
MGP11997-11-12
FCG11997-07-14
LJH11996-05-14
GAN11996-03-28
ERA11995-07-10
JES11993-01-28
KZF11992-11-03
KGX11983-02-09
FBK11981-07-31