FDA.reportPublic FDA data

TRI

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
TRICHROME LLC5Y2026-01-011519 Decatur Street Unit 208 Ridgewood NY US 11385
10367811000111918TRI-TECH FORENSICS, INC.1Y2026-01-013811 International Blvd NE Suite 100 Leland NC US 28451
11230101000123297TRINITY STERILE, INC.1Y2026-01-01201 Kiley Dr SALISBURY MD US 21801
11248323000204844TRIAID, INC.1N2026-01-01637 NORTH CENTRE ST. CUMBERLAND MD US 21502
13183541318354Trinity Biotech USA1Y2026-01-012823 Girts Rd Jamestown NY US 14701
14199511419951TRIMEDYNE, INC.1N2026-01-01519 N. Smith Avenue, Suite 105 Corona CA US 92878
14239293001451660TRICOR SYSTEMS1N2026-01-011650 TODD FARM DR. ELGIN IL US 60123
15308813002297841TRI-TECH MEDICAL, INC.1Y2026-01-0135401 AVON COMMERCE PARKWAY AVON OH US 44011
17175481717548TRI W-G, INC.1N2026-01-01215 12th Ave NE VALLEY CITY ND US 58072
19312511931251Trinity Biotech (Primus Corporation dba Trinity Biotech)1N2026-01-014231 E 75th Ter KANSAS CITY MO US 64132
20310093001236812TRIMED, INC.1Y2026-01-0127533 Avenue Hopkins Santa Clarita CA US 91355
20811592081159TRI HAWK International Corp.1Y2026-01-01150 Highland Rd MASSENA NY US 13662
20874811000253567TRIDENT LAB INC.1Y2026-01-0112000 AVIATION BLVD. HAWTHORNE CA US 90250
80309625615Tricia Cregger1N2026-01-01235 ascot parkway Cuyahoga Falls OH US 44223
80436291000273801Tricia Cregger1N2026-01-01235 Ascot Parkway Cuyahoga Falls OH US 44223
96144433002096276TRISA AG1N2026-01-01KANTONSSTRASSE 31 TRIENGEN Luzern CH 6234
96815763002546385TRINITY BIOTECH, PLC1N2026-01-01IDA BUSINESS PARK BRAY Wicklow IE --
10001136571000113657Trividia Health, Inc.1Y2026-01-012400 NW 55TH CT Fort Lauderdale FL US 33309
10004913901000491390TRIANGLE MANUFACTURING CO., INC.1N2026-01-0125 Park Way UPPER SADDLE RIVER NJ US 07458
20000108462000010846Trina Tew1N2026-01-01101 Cedar Holw Unit B Wimberley TX US 78676
30030859673003085967TRIS OTTICA SPA1N2026-01-01Via della Centa 24 Segusino Treviso IT 31040
30035964423003596442TRIGON AMERICA LLC1N2026-01-014000 Sussex Ave Aurora IL US 60504
30040508543004050854Tricol Biomedical, INC.1N2026-01-01720 SW Washington St Ste 200 PORTLAND OR US 97205
30047154353004715435TRI-STATE DENTAL SUPPLIES1Y2026-01-0124 Abeel Rd Monroe NJ US 08831
30054233733005423373TRI-FI KNITTING, LLC1N2026-01-012353 Lower East Valley Road Dunlap TN US 37327

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
163621319373783K994045PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2LCP1999-12-21
163641061687513K993839ENA PROFILE ELISA TEST SYSTEMLLL2000-01-12
1544011651629078K993017PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGEFMF2000-02-25
163641404533199K992665MACRA LP(A) ENZYME IMMUNOASSAY KITDFC1999-11-26
690771812998041K992574OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500AGEX1999-10-29
690771621595699K992230OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HPGEX1999-07-12
163641758545764K991074BARTELS LEGIONELLA URINARY ANTIGEN ELISA TESTMJH1999-12-21
2253211985417993K983679STATIM 5000 CASSETTE AUTOCLAVEFLE1999-01-04
163641813184734K980912VCA IGG ELISA TEST SYSTEMLSE1998-07-22
597271438032657K980711HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATINGLPH1998-11-12
163641650035661K980598EBNA-1 IGM ELISA TEST SYSTEMLLM1998-05-01
163641719548581K980596VCA IGM ELISA TEST SYSTEMLSE1998-07-22
129061799309347K974382ACKERMANN SURGICAL INSTRUMENTSGCJ1998-04-21
597271944408601K973412NATURAL-KNEE II CONSTRAINED KNEE SYSTEMJWH1997-12-08
690771954138272K973172RESPOSABLE BARE FIBERSGEX1998-02-03
163641767723023K973123EA-D IGG ELISA TEST SYSTEMLSE1998-03-26
163641437676988K972041EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5)LBS1997-07-22
163641520592648K971157MACRALP(A) ENZYME IMMUNOASSAY KITJHO1998-04-15
1010321919199524K971111TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPERJKA1997-06-16
690772032236119K962632OMNIPULSE/OMNIPULSE-MAXGEX1997-01-16
2253211020081986K962179STAT IM 5000 CASSETTE AUTOCLAVEFLE1997-01-13
163641191595535K961765MPO ELISA TEST SYSTEMMOB1996-08-19
163641567913304K961764PR-3 ELISA TEST SYSTEMMOB1996-08-19
163621046009633K955283PRIMUS VARIANT SYSTEM PVS99GKA1996-03-01
163641565093667K954723ENZYME IMMUNOASSAY ANA SCREENING TEST KITLKJ1995-12-15
597272018633879K953490TRILOGY ACETABULAR SHELL & LINERS 36MMLPH1995-10-20
1010321564409486K952246TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KITJXA1995-06-20
690771798168435K951562OMNIPULSE-MAX HOLMIUM LASERGEX1995-07-21
163641101304571K951549EBNA IGG EIA TEST SYSTEMLLM1996-04-29
172171026857996K951303SFCHWC1995-06-27
172171880661607K951302SMALL FRAGMENT PLATES AND SCREWSJDS1995-05-05
2253211832894401K944036STERIMASTER AUTOCLAVEFLE1996-10-02
690771187395761K941419DISPOSABLE SPINAL INTRODUCER SHEATHGEX1994-06-21
163641996011327K941358THYROGLOBULIN EIA TEST KITJNL1994-05-11
163641607396835K941085LIPASE-PS ASSAY PROCEDURE NO. 805CHI1994-05-17
163641843540579K940253HISTONE EIA TEST KITLJM1994-05-02
163641588336284K940251MITOCHONDRIA EIA TEST KITDBM1994-05-03
163641347267266K935987FLEXTRANSJSM1994-08-15
163641907716506K935419LA EIA TEST KITLLL1994-05-05
163641634947024K935418SCL-70 EIA TEST KITLLL1994-05-05
163641690777979K935417JO-1 EIA TEST KITLLL1994-05-05
163642024286789K935416RO EIA TEST KITLJM1994-05-02
163641034897800K935415RNP EIA TEST KITLJM1994-05-02
163641848306192K935414SM EIA TEST KITLJM1994-05-02
163641024704078K935413ENA EIA TEST KITLLL1994-06-02
690771508188526K934865OMNIPULSE MODEL 1210-VHP HO:YAG LASER SYSTEMGEX1994-05-12
597271273466644K934765TRILOGY ACETABULAR SYSTEMLPH1994-04-29
520751589839524K933934GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-AJBF1995-06-29
163641453896116K930477ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATORJIS1993-06-07
690771154369056K925124TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASE SYSTGEX1994-03-01
163641488381151K924056ENCORE RHEUMATOID FACTOR EIADHR1992-09-25
163641953073434K923537ENCORE DS-DNALRM1992-12-23
129061175451088K923361I.V. START KIT, STERILE, DISPOSABLELRS1993-06-28
690771099889029K923191SWITCHABLE TIP SYSTEMGEX1993-03-31
690771741221959K922496TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTGEX1994-03-01
1010321993174548K922343TRI-TECH INC. CUSTOM SEXUAL ASSAULT KITJKA1994-02-17
1010321945299335K922342TRI-TECH INC. CUSTOM BLOOD ALCOHOLJKA1993-08-27
163641726528399K921573RUBELLA IGMLFX1992-08-27
129061207240094K921394DRESSING CHANGE TRAY, STERILE, DISPOSABLEKKX1992-08-13
129061358124618K921394DRESSING CHANGE TRAY, STERILE, DISPOSABLEKKX1992-08-13
129061889582574K921204DELUXE WOUND CLOSURE TRAY, STERILE, DISPOSABLEKKX1992-08-13
163641790736294K921011PHARMACIA CMV IGM ELISALFZ1992-07-27
163641812222700K920702TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNOLGD1992-07-08
129061597972915K920517MINOR LACERATION TRAY W/ INSTRUMENT, STERILE, DISPKKX1992-05-11
690771344188091K915117MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEMGEX1992-04-02
2253211426032926K915054STATIM CASSETT AUTOCLAVE, MODIFICATIONFLE1992-08-04
690771620049885K914952MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEMGEX1991-12-20
163641555432934K914022SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUSLFY1992-01-27
690771023843925K911457TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTGEX1991-09-05
2253211567530682K910241STATIM CASSETTE AUTOCLAVEFLE1991-05-03
163641037402823K904524CAPTIA(R) SYPHILIS M, MODIFICATIONLIP1990-12-26
690772037273832K903154CONTACT FIBERS,SURGICAL PROBES & NON-CONTACT FIBERGEX1990-11-23
1010321062061259K900983TRI-TECH URINE SPECIMEN KITFMH1990-09-17
163642053819643K897006PHARMACIA MUMPS IGG ELISALJY1990-07-26
163641042921214K896295CAPTIA(R) CMV-MLFZ1990-03-06
163641295614624K894293MARDX LYME DISEASE EIA (IGM) TEST SYSTEMLSR1989-08-21
163641309408099K894224MARDX LYME DISEASE EIA (IGG) TEST SYSTEMLSR1989-08-21
163642051664294K892206MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEMLSR1989-08-15
163621990134754K891235PRIMUS MODEL CLC 330LCP1989-06-16
163641764736214K883670SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VIGNP1989-04-28
520751663790335K883525OXALATE REAGENTLPW1988-10-25
163641949027254K883427VIRGO(R) VZV-IGG ELISAGQX1989-03-10
163641550975434K883282VIRGO HSV-1 IGG ELISAGQO1989-03-10
163641716731531K883281VIRGO HSV-2 IGG ELISAGQO1989-03-10
163641826870887K883102VIRGO (R) CMV-IGG ELISAGQI1989-02-08
163641198832984K873925VIRGO(TM) MEASLES IGG ELISALJB1988-02-24
520751852466546K873342BILE ACIDS CONTROLSJJX1987-10-20
163641663864366K873088VIRGO(TM) RUBELLA IGG ELISALFX1987-09-09
520751763197355K872451BILE ACIDS CALIBRATORJIT1987-08-21
520751453096161K872296BILE ACIDS REAGENTKWW1987-08-26
597271740975630K872019BI-ARTICULAR II HIP DEVICEKWY1987-07-21
163641468761291K871905TOXOPLASMA GONDII IGG ELISALGD1987-07-30
163641061723574K860453ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040JJX1986-02-19
520751895816954K854245SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UVKQN1986-01-22
520751499334450K842366OXALATE URINE CONTROLS NORMAL & ELEVATJJW1984-09-12
163641151471284K834136PBS W/MG+2 & CA+2KIT1984-03-22
163641759903186K834125CHLAMYDIAL TRANSPORT MEDIUMJSM1984-02-13
163641858069849K834122CHLAMYDIAE ISOLATION MEDIUM W/CYCLOHEXKIT1984-02-13
163641439920134K834116DEAE-DEXTRAN IN PBSKIT1984-04-20
163641160780246K834115CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUTJSK1984-03-23
163641800507792K834113TISSUE CULTURE REFEEDING MEDIUMKIT1984-03-23
597271948533224K833991BIPOLAR HIP DEVICEKWY1984-01-30
163641999065592K802568HEMOGLOBIN CONTROLKHG1980-11-12
520751201924772K790211DEHYDROGENOSE, GLUCOSE PHOSPHATEJBL1979-03-15
172171380454103K261241TriMed Compression ScrewsHWC2026-05-14
172171734867780K254002TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S)HRS2026-01-15
172171363695929K252061Distal Xtremities SystemHRS2025-08-20
172172026580540K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)HRS2025-07-10
172171666451370K251134RipCordHTN2025-07-11
172171729745307K250948TriMed Fusion Cup SystemHRS2025-04-08
172171763863390K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw)HRS2025-05-22
172171334328870K250929TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm)HRS2025-06-26
172171241788974K243999TriMed Ankle Fixation SystemHRS2025-03-19
172171405789583K243987TriMed Elbow and Forearm SystemHRS2025-03-19
172171803241674K243943TriMed® Compression ScrewsHWC2025-04-10
172171656777644K243569TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wrist Fixation System (Hook Plates); TriMed Wrist Fixation System (Pin Plates); TriMed Wrist Fixation System (Peg Plates); TriMed Wrist Fixation System (Shear Plates); TriMed Wrist Fixation System (Wireform plates and Washer); TriMed Wrist Fixation System (Wireforms); TriMed Wrist Fixation System (Torx Cortical Screws); TriMed Wrist Fixation System (Torx Threaded Pegs);HRS2025-01-15
172171710642644K243050TriMed Posterior Malleolus Fixation SystemHRS2024-11-26
172171824809033K241942TriMed Bridge PlatesHRS2024-09-17
172171335004695K234040TriMed Threaded Intramedullary Nail SystemHWC2024-01-18
172171007304850K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate), TriMed ASET Foot Plating System (H-Plate), TriMed ASET Foot Plating System (Talonavicular Plate), TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate), TriMed ASET Foot Plating System (Evans Osteotomy Plate), TriMed ASET Foot Plating System (Medial Column Fusion Plate), TriMed ASET Foot Plating System (Straight Plate), TriMed ASET Foot Plating System (T-HRS2024-04-17

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS302026-01-15
GEX212005-12-21
NBW132023-12-01
QSY122015-11-10
FLE112021-07-01
HWC72026-05-14
JWH62019-09-05
LLL52000-01-12
NHA42022-10-26
LCP42011-11-22
JOM42011-06-13
LSR42003-11-26
LPH42002-09-05
LJM41994-05-02
KKX41992-08-13
KIT41984-04-20
FMI32018-06-27
JJX32004-08-19
LIP32002-01-24
LSE31998-07-22
JKA31997-06-16
HTN22025-07-11
GKA22023-08-04
QRL22022-10-18
DXC22017-08-29
OLR22006-07-07
MJH22003-11-26
JIS22000-06-01
LLM21998-05-01
MOB21996-08-19
JSM21994-08-15
LFX21992-08-27
LFZ21992-07-27
LGD21992-07-08
GQO21989-03-10
KWY21987-07-21
FMK12022-05-19
LHQ12021-09-13
EKX12021-05-10
JDR12019-07-01

NDC#

Oxygen

Tri State Medical Supply

Oxygen

200 records. Showing 1-40. Next

PMA#

72 records. Showing 1-40. Next

PMN#

AgeJet

2022-07-07

Triworks Group SRL

200 records. Showing 1-40. Next

Applications#