FDA.reportPublic FDA data

Tenco

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12500451250045Tender Corporation1Y2026-01-01944 INDUSTRIAL PARK RD Littleton NH US 03561
21835202183520Tenacious Holdings Inc1Y2026-01-011021 Bandana Boulevard Suite 220 Saint Paul MN US 55108
30084037013008403701TENACORE LLC1Y2026-01-013115 Airway Ave Costa Mesa CA US 92626
30093525103009352510Ten Chu1N2026-01-012243 S Throop St Chicago IL US 60608
30097507041000135560TENEX HEALTH1N2026-01-0126902 Vista Terrace Lake Forest CA US 92630
30154251073015425107TENON MEDICAL, INC.1N2026-01-01104 Cooper Court Los Gatos CA US 95032
30167152983016715298TENGFEI TECHNOLOGY CO.,LTD.1N2026-01-01149 Tongqiu Road Zhangpu Town Kunshan Jiangsu CN 215321
30175204313017520431TENOVI CO1Y2026-01-011 Cate Street STE 100 Portsmouth NH US 03801
30177268243017726824Tensentric, LLC1N2026-01-01474 South Taylor Ave Suite C Louisville CO US 80027
30177289703017728970TENNESSEE FOAM, LLC1N2026-01-01910 Callahan Dr. Ste 108 Knoxville TN US 37912
30212860873021286087TENSOR SURGICAL, INC.1N2026-01-016345 S Pecos Rd Ste 212 Las Vegas NV US 89120
30256061763025606176TENTECH INC.1N2026-01-01#802 Ace Techno Tower 5th, 20, Digital-ro 31-gil, Guro-gu Seoul KR 08380
30256639263025663926TendoNova Corporation1N2026-01-0175 5th St Nw Ste 2160 Atlanta GA US 30308
30272693553027269355TEN ACES MED LLC1N2026-01-01224 Beauteau Street Lake Zurich IL US 60047
30388050693038805069TENS FOR LABOR1Y2026-01-012220 Nicholasville Rd Ste 110 Pmb 115 Lexington KY US 40503
00TENGFEI TECHNOLOGY CO.,LTD5N2020-04-25No.111 Tongqiu Road,Zhangpu Town Kunshan City Jiangsu CN 215300
00TENGZHOU HUABAO SANITARY PRODUCTS COMPANY5N2020-04-25809 Tengfei Road Tengzhou Shandong CN 277500
00TENGDI ZHILI (SHENZHEN) TRADING CO., LTD5N2020-04-25Room 501-C2, Building R2-B, High-tech Industrial Village No. 020, High-tech South Seven Road, Yuehai Stre Shenzhen Guangdong CN 518000
30044674003004467400TENACORE HOLDINGS, INC.1N2020-04-251525 E Edinger Ave SANTA ANA CA US 92705
30088804393008880439TENSPRODUCTS, INC.1Y2020-04-2517 TEN MILE DR Granby CO US 80446
30091398023009139802TENORTHO SRL UNIPERSONALE1N2020-04-25Via Locatelli 82 Biassono Lombardia IT 20853
30100414613010041461Tensor Surgical Inc.1N2020-04-254704 Hixson Pike STE 202 Hixson TN US 37343
30100791393010079139TENVISION LLC1Y2020-04-251121 Gregory Dr Gallatin TN US 37066
30152602113015260211TENSYN MEDICAL, INC.1N2020-04-25830 Challenger Street Suite 360 Brea CA US 92821
30154371713015437171TENSION SQUARE, LLC1N2020-04-253300 Beneva Rd Suite 225 Sarasota FL US 34232

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
234971128567526K993383HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.BDSI2000-02-03
234971944775429K992503SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIESBZR1999-08-10
234971931824917K982839CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300MEA1998-11-02
1271162021848732K973978MICRO II MICROCURRENT TENSGZJ1998-07-29
234971800745732K962380OLYMPUS BF TYPE 200 VIDEO BRONCHSCOPES(BF-200/BF-P200/BF-IT200)EOQ1996-08-09
234971307468873K954351SERIES 50XMHGM1996-03-08
234971226560605K950461WELCH ALLYN OPHTHALMOSCOPEHLI1995-04-04
1251281704352494K931084TEMPITEMA1993-05-27
234971930248551K925982BMD AIR/OXYGEN BLENDERBZR1993-10-07
234971282704211K903771HP MODEL M1008B, NONINVASIVE BLOOD PRESSURE MODULEDXN1991-02-19
234971848047915K903104CAPNOMAC ULTIMA (TM) ANESTHESIA MONITORCBQ1991-01-23
1271161116739462K900997K-STERILE TENS ELECTRODESGXY1990-03-13
234971588171636K900618HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140KNG1990-04-25
234971318134784K883038P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDERBZR1988-11-16
234971273433918K844403MODEL FORCE 2 ELECTROSURGICAL GENERATORGEI1985-02-20
1271161641542167K780973SIGNAPADGYB1978-07-27
2811691666535800K251331Blood Pressure Monitor (B73, BE23T)DXN2025-10-27
2277542001732340K250647SImmetry+ SystemOUR2025-07-29
2811691169979371K241351Blood Pressure Monitor (TMB-2092-G)DXN2024-08-21
3128251101836654K23299210THERMAGEI2023-12-20
2811691928473999K223722MIO Blood Glucose Monitoring SystemNBW2023-06-28
3128251052180408K22079410PLONF2022-11-10
2811691983602071K220475Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T)QRL2022-07-06
3125951886915084K212049Oclet TDS 1000LFL2022-03-08
2811691596537351K203196Peak flow meterBZH2021-05-26
2811691542853191K202891Blood Pressure MonitorDXN2021-03-09
1516401177578282K181367Tenex Health TX System with the TXP MicroTipLFL2018-08-28
2277541821960110K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)OUR2018-06-13
2811691854927078K172795Infrared ThermometerFLL2018-03-14
234971918341665K171865F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer MonitoringHGM2017-08-24
2811691108902283K171480NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring SystemNBW2017-12-13
2811691351076660K170965Fingertip Pulse OximeterDQA2017-11-03
1516401262886314K153299Tenex Health TX SystemLFL2016-03-03
2277541212748724K151818SImmetry Sacroiliac Joint Fusion SystemOUR2015-08-05
2265411631178312K150359Tensyn PlugHTN2015-05-07
2811691580220513K140582FINGERTIP PULSE OXIMETERDQA2014-08-28
1271161734014134K132588ADHESIVE ELECTRODESGXY2013-11-22
2811691213975062K131457FETAL ULTRASONIC MONITOR AND ACCESSORIESKNG2014-01-24
2811691884643679K131395TRANSTEK BLOOD PRESSURE MONITORDXN2013-06-19
234971164307125K131364FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPEFBO2014-01-02
1516401667775868K123640TX1 TISSUE REMOVAL SYSTEMLFL2013-03-20
234972064143666K122439INTELLIVUE PATIENT MONITORMHX2012-08-29
234971926056816K112652SURESIGNS VS2+ -SURESIGNS VSIDXN2011-10-11
1251281788025365K112126GENUINE FIRST AID CPR MASKCBP2011-12-01
1251281235973332K110776DIGITAL THERMOMETER MT SERIESFLL2011-08-24
1271161533046180K110509EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908LIH2011-06-20
234971212352768K110266MAC 5500 HD, MAC 3500DPS2011-04-29
1251281158502596K100855POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)LYZ2010-04-22
234971959763567K093788INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTIONMHX2010-03-08
234971553029500K091834PASSPORT V MONITOR, MODEL 0998-00-6100MHX2009-07-15
1271161471933517K091248MAXEMS, MODELS 1000 AND 2000IPF2009-11-30
234971180584346K090556SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWAREMHX2009-04-30
234971828554837K090285SONICAID FM820 AND FM830 ENCOREHGM2009-07-15
234971728020872K090136STERIS CMAX XLT SURGICAL TABLEFQO2009-03-20
1271162047524936K083302LIFECARE ELECTRODESGXY2009-08-03
234971624144439K081983M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00MHX2008-08-22
234971099381955K081335TENACORE OXYGEN BLENDER, MODEL TB-2000BZR2008-11-14
1271161068386200K073438PROSTIM 1000/2000GZJ2008-02-07
1251281314527615K072474QUIKCLOT EXQSY2007-10-16
1251281452415971K072145MEDICAL GLOVE SERIESLYY2008-02-26
1271161614391566K071951COMFY SERIES: EV-804, EV-805 & EV-806GZJ2007-09-05
234971531379600K071800PHILIPS AVALON FETAL MONITORS FM20 AND FM30HGM2007-09-27
234971711478411K071530KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEMEOQ2007-08-24
234971433591013K071073SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULEMHX2007-05-11
1251281138678189K070149POWDER-FREE VINYL PATIENT EXAMINATION GLOVESLYZ2007-02-23
234971919685562K062137MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30HGM2006-08-24
234971221620812K061605NEMIO XG, SAA-580AIYN2006-06-22
234971262904011K053420TENACORE SP02 SENSORSDQA2006-11-15
1271161505388132K053214THERAKNIT GARMENT ELECTRODEGXY2005-12-20
234971645910406K053204INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013ACCK2006-02-03
234971708800236K053168BIPAP FOCUSMNS2006-01-04
234971280762210K052973IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107KFRN2007-01-25
1251281056611432K052458LIV MEDICA CPR FACE MASKCBP2006-07-07
234971841312779K050583MODEL 250 SERIES MATERNAL/FETAL MONITORHGM2005-06-21
234971270460153K043075TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORINGHGM2005-08-18
2882011687041268K043075TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORINGHGM2005-08-18
1271161384216190K042301PROTENS ELECTRODEGXY2004-09-03
234971402616243K041741M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIENMHX2004-07-21
234971272165616K040743MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEMBSZ2004-04-22
234971766177975K040458MODIFICATION TO DASH 3000/4000 PATIENT MONITORMHX2004-06-03
234971882028991K033988GOLDWAY UT4000A VITAL SIGNS MONITORMWI2004-02-25
1271161128805845K033544ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607IPF2003-12-10
234971929079621K031781DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIESMHX2003-06-25
1271162036289821K024013SUN-RAIN ULTRASONIC THERAPY, SU-100IMI2003-10-31
1271161734945298K020749DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENSGZJ2002-10-31
234971230296098K020531PHILIPS MULTI-PARAMETER MODULE, MODEL M3001A; PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.02, MODEL M1275BMHX2002-03-20
1271161787452624K013813MODIFICATION TO:APEX MEDICAL IF-4100GXY2001-12-14
1271161036237728K012463LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVALGXY2002-02-05
1271161488380296K003487STIMATE N601 TENSGZJ2001-01-24
234971833332711K002758AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76ADSI2001-02-22
234971461440988K001814DATEX-OHMEDA COMPACT AIRWAY MODULE M-CAIOVX AND M-COVX (VERSION 01) AND ACCESSORIESCCK2000-08-23
1251281019006534
2406671042579404
1251281047478193
2420371170457438
1251281178911949
1251281236898515
1251281239756590
1251281252868302
1251281281535400
1251281290385655
1251281294701024
1251281317478437
1251281377595186
1251281378114184
1251281388753347
1251281421489717
1251281437703841
2420371514057254
2507841525765420
1251281558597178
1251281586642769
1251281590873207

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MHX102012-08-29
HGM82017-08-24
GXY72013-11-22
DXN62025-10-27
GZJ52008-02-07
LFL42022-03-08
CBP42011-12-01
LYZ42010-04-22
BZR42008-11-14
OUR32025-07-29
FLL32018-03-14
DQA32017-11-03
GEI22023-12-20
NBW22023-06-28
KNG22014-01-24
IPF22009-11-30
LYY22008-02-26
EOQ22007-08-24
CCK22006-02-03
DSI22001-02-22
EMA21993-05-27
ONF12022-11-10
QRL12022-07-06
BZH12021-05-26
HTN12015-05-07
FBO12014-01-02
LIH12011-06-20
DPS12011-04-29
FQO12009-03-20
QSY12007-10-16
FRN12007-01-25
IYN12006-06-22
MNS12006-01-04
BSZ12004-04-22
MWI12004-02-25
IMI12003-10-31
MEA11998-11-02
HLI11995-04-04
CBQ11991-01-23
GYB11978-07-27

NDC#

Itch Eraser

Tender Corporation d/b/a Adventure Ready Brands

Diphenhydramine HCl

Itch Eraser Gel

Tender Corporation d/b/a Adventure Ready Brands

Diphenhydramine HCl

After Bite Kids

Tender Corporation d/b/a Adventure Ready Brands

Sodium Bicarbonate

After Burn

Tender Corporation d/b/a Adventure Ready Brands

2.5% Lidocaine HCl

After Bite Xtra

Tender Corporation d/b/a Adventure Ready Brands

Diphenhydramine HCl

Oxygen

Tennessee Medical Equipment, Inc.

Oxygen

Tenacious

Tenacious Holdings, Inc.

SPF 50 Sunscreen Lotion

Tenacious

Tenacious Holdings, Inc.

KREWD Clear SPF 50 Continuous Spray

PMN#

HOTPAD

1993-02-12

TEN COMFORT CORP.

Applications#

GUDID#

Elastic, Orthodontic - A non-sterile device intended to be used during orthodontic treatment to function as an archwire/bracket ligature on several adjacent teeth and/or to exert a continuous light force to close the spaces between the teeth. It is also known as a power chain and is in the form of a series of connected loops made of an elastomeric material (e.g., polyurethane, rubber). This is a single-patient device intended to be replaced regularly during orthodontic treatment (single-use).

Tenco

2017-12-07