FDA.reportPublic FDA data

TRIMEDYNE, INC.

Matched from indexed company URL: Trimed, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
14199511419951TRIMEDYNE, INC.1N2026-01-01519 N. Smith Avenue, Suite 105 Corona CA US 92878
20310093001236812TRIMED, INC.1Y2026-01-0127533 Avenue Hopkins Santa Clarita CA US 91355
30309893013030989301TRIMEDIKA LTD1N2026-01-01Whiterock Business Park 739 Springfield Road Belfast Mid Ulster GB BT12 7FP

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
00842188129773Tools - AFS - HEX3.2C Screw Caddy+1(661)255-7406info@trimedortho.com
00842188131127Tools - WS3 - WS3 Long Plate Caddy+1(661)255-7406info@trimedortho.com
00842188131134Tools - WS3 - WS3 Long Plate Caddy Lid+1(661)255-7406info@trimedortho.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
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
690771954138272K973172RESPOSABLE BARE FIBERSGEX1998-02-03
690772032236119K962632OMNIPULSE/OMNIPULSE-MAXGEX1997-01-16
690771798168435K951562OMNIPULSE-MAX HOLMIUM LASERGEX1995-07-21
172171026857996K951303SFCHWC1995-06-27
172171880661607K951302SMALL FRAGMENT PLATES AND SCREWSJDS1995-05-05
690771187395761K941419DISPOSABLE SPINAL INTRODUCER SHEATHGEX1994-06-21
690771508188526K934865OMNIPULSE MODEL 1210-VHP HO:YAG LASER SYSTEMGEX1994-05-12
690771154369056K925124TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASE SYSTGEX1994-03-01
690771099889029K923191SWITCHABLE TIP SYSTEMGEX1993-03-31
690771741221959K922496TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTGEX1994-03-01
690771344188091K915117MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEMGEX1992-04-02
690771620049885K914952MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEMGEX1991-12-20
690771023843925K911457TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTGEX1991-09-05
690772037273832K903154CONTACT FIBERS,SURGICAL PROBES & NON-CONTACT FIBERGEX1990-11-23
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
172171989185837K230805TriMed Clavicle Fixation SystemHRS2023-09-01
172171798740733K230749TriMed Threaded Intramedullary Nail SystemHWC2023-04-17
172171901351148K222637TriMed Wrist Fixation System 3HRS2022-12-21
172171746185600K220650TriMed Ripcord DeviceHTN2022-06-01
172171163726828K211783TriMed Threaded Intramedullary Nail SystemHWC2021-08-06
172171595998234K192696TriMed ASET Foot Plating SystemHRS2020-01-05
172171842542997K190166TriMed Nitinol Staple SystemJDR2019-07-01
172171874569612K161746ARIX Hand SystemHRS2016-09-21
172172003608205K151735TriMed Humeral Supracondylar Fixation SystemHRS2016-01-29
172171793390635K140453OSTEOTEC SILICONE FINGER IMPLANTKYJ2015-04-17
172171347393790K132876ARIX HAND LOCKING SYSTEMHRS2013-12-18
172172008704996K131566ARIX HAND SYSTEMHRS2013-11-04
172171681803863K112794EOS SMALL BONE FIXATION SYSTEMHRS2012-05-10
172171906615400K112509TRIMED CLAVICLE FIXATION SYSTEMHRS2011-11-04
172171151357374K111266EASYLOCK OSTEOSYSTEMHRS2011-10-06
172171156579073K102785TRIMED RADIOCARPAL FUSION SYSTEMHRS2011-08-19
172171133385964K101375TRIMED X-FIXNDK2010-09-15
172171765397469K093676OMNITECH LARGE, TRIMED COMPRESSION SCREWHWC2010-03-17
172171186312784K091156TRIMED STERILE PRODUCTHRS2009-07-15
172171096523208K081348TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEADMBI2008-10-17
172171869887847K071876CROSS.BONEMQV2007-12-17
172171746994090K060041TRIMED BONE PLATESHRS2006-02-07
690771708704828K053457VAPORMAX IIGEX2005-12-21
172171282427363K050681OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATESHRS2005-07-27
172171309171429K043263TRIMED OSTEOTOMY PLATEHRS2005-01-14
690771752191465K043012OMNIPULSE MINI, MODEL 2120GEX2004-11-17
690771481641641K041660TRIMEDYNE HOLMIUM LASER SYSTEMSGEX2004-09-08
172171263141312K040112TRIMED BEARING PLATE; TRIMED VOLAR BEARING PLATEHRS2004-03-12
172171698861255K030877TRIMED RADIAL BULLETHRS2004-02-05
690771520605047K022655TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATHGEX2002-11-07
690771765028451K013974RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-AGEX2002-09-23
172171015747637K010545TBWNDL2001-06-06
690771035978327K002308OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-AGEX2000-12-20
690771829747997K001676OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-AGEX2000-11-02
172171034228649
172171035687494
172171154608143
172171168318852
172171177725914
690771180918219
172171327958166
172171438293180
172171544025843
172171584176355
3284561675933311
172171744164550
172171822752643
172171903085454
172171906042874
172171960213930
172172004930105
172172017661664
172172031710785
172172052241463

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS292026-01-15
GEX212005-12-21
HWC72026-05-14
HTN22025-07-11
JDR12019-07-01
KYJ12015-04-17
NDK12010-09-15
MBI12008-10-17
MQV12007-12-17
NDL12001-06-06
JDS11995-05-05

PMA#

43 records. Showing 1-40. Next

PMN#

87 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next