FDA.reportPublic FDA data

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FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10529671000113866TRANSITIONS OPTICAL, INC.1Y2026-01-019251 Belcher Rd N PINELLAS PARK FL US 33782
12191251219125Transene Company, Inc.1N2026-01-0110 Electronics Ave DANVERS MA US 01923
13190301319030TRANSONIC SYSTEMS, INC.1N2026-01-0134 Dutch Mill Rd ITHACA NY US 14850
16485573000205606TRANSLITE1N2026-01-01345 Commerce Green Blvd SUGAR LAND TX US 77478
29380712938071TRANSAMERICAN TECHNOLOGIES INTERNATIONAL1Y2026-01-01220 Porter Drive Suite 120 SAN RAMON CA US 94583
80108033002655329TRANSCOJECT GMBH1N2026-01-01RUEGENSTRASSE 8 NEUMUENSTER Schleswig-Holstein DE 24539
30031524633003152463TRANSMEDICS, INC.1N2026-01-01200 MINUTEMAN RD STE 302 Andover MA US 01810
30053463823005346382Transcendencias Comerciales S.L1N2026-01-01C/ Troya Ibilbidea 16, Nave 5A8/5B8 Ergobia-Astigarraga Guipuzcoa ES 20115
30086408013008640801TRANSDUCERWORKS1N2026-01-012821 Earlystown Road Centre Hall PA US 16828
30103093033008699663TRANSDERMAL CAP INC dba LaserCap Company1N2026-01-0126 Alpha Park Highland Heights OH US 44143
30104107103010410710TRANSPOWER CORPORATION LTD.1N2026-01-01Flat B, 11/F, Hung Mou Industrial Bldg 62 Hung To Rd Kwun Tong, Kowloon HK 00000
30112114163011211416trans radial solutions1N2026-01-011324 Hobbysville Rd Roebuck SC US 29376
30137674213013767421TRANSMEDIC HEALTHCARE SDN BHD1N2026-01-01B4-1-1, Solaris Dutamas, No 1, Jalan Dutamas 1 Kuala Lumpur Kuala Lumpur MY 50480
30154994453015499445TRANSCEND BIOLOGICS, LLC1Y2026-01-015916 Stone Creek Drive Suite 120 The Colony TX US 75056
30169484503016948450TRANSIT SCIENTIFIC, LLC1N2026-01-012757 S 300 W Suite E Salt Lake City UT US 84115
30208997893020899789Transmedic Philippines Inc.1N2026-01-019F Petron Mega Plaza, #358 Sen. Gil, Puyat Avenue, Brgy., Bel-Ai Makati City Manila PH 1209
30338419143033841914TRANSMED (CHINA) CO., LTD.1N2026-01-01Room 204, Building B01, Xingchuang Industrial Park, No.142 Huaka 210044, Nanjing, Jiangsu Province, P.R. China Nanjing Jiangsu CN 210044
30360401873036040187Transtimulation Research Inc1N2026-01-01898 N Fair Oaks Ave, Unit C Pasadena CA US 91103
30387724013038772401TRANSPARENT SUPPLY SOLUTIONS LTD.1Y2026-01-018 The Green, Ste A Dover DE US 19901
11225301122530TRANS-TYPE OF MARYLAND, INC.1N2020-04-253513 URBANA PIKE FREDERICK MD US 21704
17210971721097TRANSTRACHEAL SYSTEMS1N2020-04-2514 Inverness Dr E Ste H100 Centennial CO US 80112
97105213003304598TRANSITIONS OPTICAL PHILS INC.1N2020-04-25BLK. 4, LOT 1 STAR AVE., LIIP, MAMPLASAN BINAN Laguna PH 4024
30094945323009494532TRANSFER TECHNOLOGY Inc.1N2020-04-255702 Bolsa Ave. Suite 200 Huntington Beach CA US 92649
30113020583011302058TranS11N2020-04-253804 Park Avenue Suite C Wilmington NC US 28403
30114978473011497847TRANSASIA BIO-MEDICALS LIMITED1N2020-04-25SDF-VI, Unit 161/162 SEEPZ, Andheri East Mumbai Maharashtra IN 400096

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B17791852BDW0Accu-Beam - Re-usable fiberoptic handpiece for lasers.340mm, 20 degree bend, double wall.9255537828info@ttimedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1639671360137588P200031Organ Care System (OCS™) LiverQQK2021-09-28
1639671996159695P180051Organ Care System (OCS) Heart SystemQIK2021-09-03
1639671454657405P160013Organ Care System (OCS™) Lung SystemQBA2018-03-22
36761280035144K981080SCOOP 1BTO1998-06-17
310231157437406K980987BECTON DICKINSON SYRINGEFMF1998-06-11
310231501393747K980906TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-COMQS1998-10-06
693891924795886K970482TRANSCOM COLON HYDROTHERAPY MODEL HC-2000KPL1997-10-31
310231878148526K960817HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2)MQS1997-02-11
391201921770405K952006ACCU-BEAM FIBER OPTIC HANDPIECEGEX1995-05-31
391201557681541K945648ACCU-BEAM C02 LASER HANDPIECEGEX1995-02-24
391201681280536K934398ACCU-BEAM TISSUE DRILL & ASPIRATION/INJECTION NEEDLEGCJ1994-02-14
3045171970516273K932699ARTHREX AR-8200 SHAVER SYSTEMHWE1994-01-25
391201947351513K921208ACCU-BEAM TUBE SETGCJ1993-06-01
391201133812333K910978ACCU-BEAM LAPAROSCOPIC SYSTEMGEI1991-11-07
3045171045379034K901035FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLEFST1990-04-23
391201165139608K895656ACCU-BEAM WAVEGUIDEGEX1990-02-22
391201123973914K890922ACCU-BEAM YAG FIBERGEX1989-05-15
310231164953897K872048TRANSONIC FLOWMETERDPW1988-06-21
391201794780000K870046DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SETHHR1987-03-05
391201270445611K864378CO2 LASER MICROMANIPULATORHHR1987-03-05
36761069234094K854252TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETERBTO1986-02-03
3407501965013630K243133Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric AcidLZA2025-06-17
3318111116535061K241361Arthrex Synergy Vision Endoscopic Imaging SystemGCJ2024-07-25
3045171306830470K241361Arthrex Synergy Vision Endoscopic Imaging SystemGCJ2024-07-25
3318111451082347K241235Arthrex TightRope IIMBI2024-05-29
3318111650379855K232973Arthrex Knee FiberTak® Button Suture AnchorMBI2023-11-15
2698391010192069K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterPNO2024-06-17
2698391763848440K231821XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)KRA2023-11-29
1639671960535566K231362OCS Heart Leukocyte Depleting FilterDTM2023-10-31
3368291124594100K230526TEA DeviceQHH2023-09-14
3318111152632190K230433Arthrex Knotless FiberTak Suture AnchorMBI2023-03-10
1639672009623388K222535OCS Lung Donor Flush SetMSB2022-11-18
3318111123504085K222161Arthrex Knotless FiberTak Biceps Suture AnchorMBI2022-08-11
2698391061078315K221986XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP CatheterPNO2022-10-18
3318112046854903K221396Arthrex FiberTak Suture AnchorMBI2022-12-22
3318111369789922K220947Arthrex Knotless AC Repair DevicesHTN2022-06-06
3407501706119217K220215Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with Chemotherapy Drugs, and the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (Blue)LZA2022-03-26
3407501037193493K220118Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination GlovesLZA2022-05-12
2698391289775671K214107XO CROSS CORONARY Support CatheterDQY2022-04-11
3407501624687182K212613Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue)LZA2021-12-21
1639671423000631K211314OCS Lung SolutionMSB2021-07-29
3407501580249932K210745Heel Incision Safety LancetFMK2021-08-26
2698391112591611K210322XO Cross Support CatheterDQY2021-10-21
1865071696215576K203826LaserCap Family of Lasers 300, 224, 120 & 80OAP2021-03-29
3318111752824197K203268Arthrex FiberTak Suture AnchorMBI2020-11-27
3045171233485366K201134Arthrex NanoScope SystemGCJ2020-09-04
3318111779126440K201132Arthrex Compression ScrewsHRS2020-07-27
3318111300285514K200341Arthrex FiberTak Suture AnchorMBI2020-03-12
3407501741850950K193555Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl CitrateLZC2020-06-04
2698391621486845K193495XO Score Percutaneous Transluminal Angioplasty Scoring CatheterPNO2020-05-29
2698391749816076K193420XO Cross Support CatheterDQY2020-05-06
3045171446467799K183395Arthrex 2.5 mm Tenodesis ScrewHWC2019-04-17
3045171755420846K181769Arthrex FiberTak Suture AnchorMBI2018-09-21
3318111904735267K181769Arthrex FiberTak Suture AnchorMBI2018-09-21
3045171300344634K180662Arthrex FastThread Interference ScrewMAI2018-05-22
3045171599785264K180594Knotless SutureTak AnchorsMAI2018-06-22
3092791484276612K180461Navi e/Navi s/Navi X Diagnostic Ultrasound SystemIYN2018-05-09
3407501414762764K172763Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with HolderJKA2018-06-04
3318111314363460K172612FiberTak DXMBI2017-09-28
3318112044061633K171296SutureTapeGAT2017-05-26
3045171051016993K161581Arthrex Synergy RF SystemGEI2016-09-09
3325001618903378K161463SureClip(TM) Repositionable Hemostasis ClipPKL2017-01-06
3045171068923739K153218Arthrex Synergy UHD4 SystemGCJ2016-02-12
3318111942774396K151230Arthrex FiberTak AnchorsMBI2015-06-19
1865071342235068K150613LaserCap LC Pro and LC EliteOAP2015-07-22
3045171611714810K140855ARTHREX SUTURETAK SUTURE ANCHORSMAI2014-12-18
310231284211192K140740TRANSONIC TISSUE PERFUSION MONITORDPW2015-07-23
3045171947081739K140328CMC MINI TIGHTROPEHTN2014-03-10
310231049090392K134051TRANSONIC ELSA SYSTEMDXG2015-01-29
310231511792651K134035TRANSONIC HCM 103 SYSTEMDXG2014-09-17
3045171965636915K133275MINI TIGHTROPEHTN2014-01-30
3045171924709526K132043ARTHREX SPEEDCINCHGAT2013-07-31
693891685877423K131852HC-1 AND HC-1 CLASSICKPL2014-04-17
1764572012280589K130915XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACKJJE2014-05-15
3318111535738766K130458KNOTLESS FIBERTAK SUTURE ANCHORMBI2013-05-03
3045171947616420K130458KNOTLESS FIBERTAK SUTURE ANCHORMBI2013-05-03
3045171306020493K122374ARTHREX SUTURE (UHMWPE)GAT2012-09-25
310231693917400K113821TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEMDXG2012-09-07
3045171590763485K112990ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLEHTY2011-12-19
310231872093233K112657AUREFLO MONITORING SYSTEMDPW2011-12-21
3045171273558101K110123PCL TIGHTROPEHTY2011-04-28
1772061995252141K102334TRANS1 AXIALIF PLUSKWQ2011-03-14
3045171592830562K101823ARTHREX SWIVELOCK ANCHORSMAI2011-01-07
3045171942581900K101679ARTHREX PUSHLOCK ANCHORSMAI2010-10-22
3045171783743070K090107MINI TIGHTROPEHTN2009-08-06
3045171880427694K083707ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICEHRX2009-08-03
3045171963564600K082810ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK AND BIO-COMPOSITE CORKSCREWMAI2009-01-23
1371011667201880K081279PRO-TECH DELIVERY SYSTEM ELECTRODES, MODEL TT-2000GXY2009-01-23
3045171153165137K080560HENKE SASS WOLF OF AMERICA ARTHROSCOPEHRX2008-03-18
310231573592532K080116TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEMDXG2008-09-08
1772061787788378K073515TRANS1 FACET SCREWMRW2008-03-11
3045171508123721K073149MENISCAL CINCHGAT2008-02-11
3045171679964562K071756ENDOHUB- 1.0 ENDOSCOPIC VIDEO CAMERA SYSTEM WITH VIDEO CAPTUREGCJ2007-08-15
310231747790137K071459B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGESFMF2007-08-16
3045171034700792K071176MODIFICATION TO: ARTHREX INTERFERENCE SCREWMAI2007-08-03
3045171149359623K063479ARTHREX PUSHLOCKHWC2006-12-13
3045171370181712K062466ARTHREX INTERFERENCE SCREWMAI2006-11-29
3045171918074195K061863ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILYHWC2006-10-19
3045171256899556K052776TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBDHTN2005-12-13
3045171503699798K051726ARTHREX TENODESIS FAMILYHWC2005-09-27
3045171058774916K050749ARTHREX TAK FAMILYHWC2005-05-12
3045171077199587K043248TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DSHTN2005-02-16
310231961162787K033424ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002DPW2003-12-11
310231762292489K031923ULTRASITE VALVEFPA2003-08-11
3045171787081836K024291ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475HRX2003-03-20
310231046270178K021571TRANSONIC FLOW-QC SET MODEL ADT1010MQS2002-08-12
310231887358335K010253ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101DYG2002-03-19
3318111150963340K002469IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)EBW2001-02-07
3092791191317002BK110035
3045172004926459BK070069
300911052075717
300911087192599
300911112667670
1764571276509292
1772061369177532
300911403463247
300911427767293
310231483794776
300911566802433
1764571599945075

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MBI132024-05-29
MAI82018-06-22
GCJ72024-07-25
HTN62022-06-06
HWC52019-04-17
LZA42025-06-17
GAT42017-05-26
DPW42015-07-23
DXG42015-01-29
GEX41995-05-31
PNO32024-06-17
DQY32022-04-11
HRX32009-08-03
MQS32002-08-12
MSB22022-11-18
OAP22021-03-29
GEI22016-09-09
KPL22014-04-17
HTY22011-12-19
FMF22007-08-16
BTO21998-06-17
HHR21987-03-05
KRA12023-11-29
DTM12023-10-31
QHH12023-09-14
QQK 12021-09-28
QIK 12021-09-03
FMK12021-08-26
HRS12020-07-27
LZC12020-06-04
JKA12018-06-04
IYN12018-05-09
QBA12018-03-22
PKL12017-01-06
JJE12014-05-15
KWQ12011-03-14
GXY12009-01-23
MRW12008-03-11
FPA12003-08-11
DYG12002-03-19

NDC#

PMA#

Organ Care System (OCS®) Liver™

2022-09-19

TransMedics, Inc.200 Minuteman Roadsuite 302andover, MA 01810 PMA NumberP200031 Supplement NumberS001 Date Received04/08/2022 Decision Date09/19/2022 Product Code QQK  Advisory Committee Gastroenterology/Urology Clinical TrialsNCT02522871 Supplement Typenor...

Organ Care System™ (OCS) Lung System

2022-05-06

TransMedics, Inc200 Minuteman Roadsuite 302andover, MA 01810 PMA NumberP160013 Supplement NumberS009 Date Received02/07/2022 Decision Date05/06/2022 Product Codes PHO QBA  Advisory Committee Gastroenterology/Urology Supplement Typereal-time Process Suppleme...

OCS Heart System

2022-04-27

TransMedics, Inc.200 Minuteman Road, Suite 302andover, MA 01810 PMA NumberP180051 Supplement NumberS001 Date Received11/08/2021 Decision Date04/27/2022 Product Code QIK  Advisory Committee Cardiovascular Clinical TrialsNCT03831048 Supplement Typepanel Track...

PMN#

TEA Device

2023-09-14

Transtimulation Research, Inc.

179 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next