FDA.reportPublic FDA data

MEDART ApS

Matched from indexed company URL: MEDART CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80215433005616124MEDART ApS1N2026-01-01INDUSTRIHOLMEN 15A HVIDOVRE Hovedstaden DK DK-2650
30032367023003236702MEDARTIS AG1N2026-01-01HOCHBERGERSTRASSE 60E BASEL Basel-Stadt CH CH-4057
30095407493009540749Medartis Inc.1Y2026-01-011195 Polk Drive Warsaw IN US 46582
30381891883038189188MEDART TECHNOLOGY EUROPE1N2026-01-01324 Route des Vernes 74370 Annecy , France Annecy Savoie FR 74370
30052158243005215824MEDARTIS, INC.1Y2020-04-25224 Valley Creek Boulevard Suite 100 Exton PA US 19341

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3093712021617865P240020TOUCH® CMC 1 ProsthesisSFA2025-07-10
547231558350663K993862MODUS SAGITTAL SPLIT PLATEJEY1999-12-29
99171570392955K993815UNI-LASER 430GEX2000-05-11
547231465779966K992682MODUS 2.5 MANDIBULAR RECONSTRUCTION SETJEY1999-11-24
547231950801564K992106MODUS SYSTEM SELF-DRILLING SCREWSHWC1999-09-17
99171936759475K991297UNI-LASER 450P CO2 LASER SYSTEM & ACCESSORIESGEX1999-07-12
99171563878771K984339MEDART 455 SCANNER SYSTEMGEX1999-02-18
547231096607092K260934TITAN Nail; APTUS K-Wire SystemHWC2026-04-17
547231860272886K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5HRS2026-03-16
3093711860272886K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5HRS2026-03-16
3381991471655220K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)GEX2025-06-12
547231056386253K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonHRS2025-03-07
3093711056386253K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonHRS2025-03-07
3381991656632459K242941CO2 Laser Therapy Systems (SHE-LSP003-1)GEX2025-01-27
547231354065185K240613APTUS Elbow Dorsal Olecranon PlatesHRS2024-06-20
3093711354065185K240613APTUS Elbow Dorsal Olecranon PlatesHRS2024-06-20
547231997780283K234062APTUS Hand Scaphoid PlatesHRS2024-03-21
3381991759449455K233416Cryojet Plus (SHE-ACP001-1)GEX2024-02-06
3093711368569290K232324StealthFix Intraosseous Fixation SystemJDR2023-08-30
547231356334431K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionHWC2023-11-03
547231879027036K232144Sterile Products of the APTUS SystemHRS2023-08-18
547231615120149K232105APTUS Foot System 2.8-3.5HRS2024-04-19
547231656496776K230971APTUS® 3.5 TriLock Straight PlatesHRS2023-06-02
3381991706986935K230024HI-EMT MAGSHAPENGX2023-09-06
547231890044055K223853Medartis APTUS® Ulna PlatesHRS2023-03-30
3093711707440951K220181StealthFix Intraosseous Fixation SystemJDR2022-03-22
3093711401906119K212979CalcShift™ Displacement Calcaneal Osteotomy SystemHRS2022-05-20
547231458595976K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire SystemHWC2020-11-06
3093711458595976K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire SystemHWC2020-11-06
3093711979805023K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw RangeHRS2020-03-23
547231832202542K193639APTUS® Foot 2.8-3.5 SystemHRS2020-03-26
3093711832202542K193639APTUS® Foot 2.8-3.5 SystemHRS2020-03-26
547231688000254K193633APTUS® Ankle Trauma System 2.8/3.5HRS2020-03-26
3093711688000254K193633APTUS® Ankle Trauma System 2.8/3.5HRS2020-03-26
547231426760320K193554APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 SystemHRS2020-02-16
3093711426760320K193554APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 SystemHRS2020-02-16
547231596752490K192984APTUS Clavicle SystemHRS2020-01-24
3093711596752490K192984APTUS Clavicle SystemHRS2020-01-24
547231109629818K192297APTUS Wrist Arthrodesis PlatesHRS2019-11-08
3093711109629818K192297APTUS Wrist Arthrodesis PlatesHRS2019-11-08
3381991093016705K191970Diode Laser Hair Removal SystemGEX2020-04-06
547231624454465K191848APTUS Wrist Spanning Plates 2.5HRS2019-09-30
547231019149188K191636APTUS Foot SystemJDR2019-08-16
3093711019149188K191636APTUS Foot SystemJDR2019-08-16
547231221730796K181425APTUS® Proximal Humerus SystemHRS2018-08-05
3093711221730796K181425APTUS® Proximal Humerus SystemHRS2018-08-05
547231013714097K181009APTUS CMC-I Fusion Plate SystemHRS2018-08-24
3093711013714097K181009APTUS CMC-I Fusion Plate SystemHRS2018-08-24
3093711418771336K180348Field Orthopaedics Micro Screw SystemHWC2018-07-17
547231679043833K172170APTUS(R) Wrist 2.5 SystemHRS2017-09-08
3093711679043833K172170APTUS(R) Wrist 2.5 SystemHRS2017-09-08
3093711741901141K163440Stealth Staple SystemJDR2017-02-01
547231346804098K161861APTUS® Coronoid 2.0HRS2017-02-09
3093711346804098K161861APTUS® Coronoid 2.0HRS2017-02-09
3093711356584336K153622First Ray Internal Bone Staple SystemJDR2016-04-08
547231212797734K142906APTUS Wrist 2.5 SystemHRS2015-06-09
3093711212797734K142906APTUS Wrist 2.5 SystemHRS2015-06-09
547231815159858K142581APTUS Foot SystemHRS2015-04-09
3093711815159858K142581APTUS Foot SystemHRS2015-04-09
547231401084520K141232APTUS ULNA SHORTENING 2.5HRS2014-06-23
3093711401084520K141232APTUS ULNA SHORTENING 2.5HRS2014-06-23
547231331793015K133460APTUS CANNULATED COMPRESSION SCREWSHWC2013-12-18
3093711331793015K133460APTUS CANNULATED COMPRESSION SCREWSHWC2013-12-18
99171977069868K120573MEDART 620GEX2012-06-13
547231349144403K120108APTUS PROXIMAL HUMERUS SYSTEMHRS2012-04-27
3093711349144403K120108APTUS PROXIMAL HUMERUS SYSTEMHRS2012-04-27
547231362155664K112560APTUS(R) DISTAL HUMERUS SYSTEMHRS2011-12-15
3093711362155664K112560APTUS(R) DISTAL HUMERUS SYSTEMHRS2011-12-15
547231339916583K112169APTUS WRIST ARTHRODESIS PLATESHRS2012-01-06
3093711339916583K112169APTUS WRIST ARTHRODESIS PLATESHRS2012-01-06
547231543886548K110908APTUS FOOT 3.5 SYSTEMHRS2011-06-28
3093711543886548K110908APTUS FOOT 3.5 SYSTEMHRS2011-06-28
547231061568802K110658APTUS CANNULATED COMPRESSION SCREWSHWC2011-06-02
3093711061568802K110658APTUS CANNULATED COMPRESSION SCREWSHWC2011-06-02
99171337064863K110243MEDART DIODE LASER SYSTEM & ACCESSORIESGEX2011-06-28
547231047027992K103332APTUS ULNA PLATESHRS2011-01-24
3093711047027992K103332APTUS ULNA PLATESHRS2011-01-24
547231691934260K102537APTUS 1.5 TRILOCKHRS2010-12-10
3093711691934260K102537APTUS 1.5 TRILOCKHRS2010-12-10
547231542835718K092038APTUS K-WIRE SYSTEMHTY2009-09-23
3093711542835718K092038APTUS K-WIRE SYSTEMHTY2009-09-23
547231701869446K091479APTUS FOOT SYSTEMHRS2009-07-13
3093711701869446K091479APTUS FOOT SYSTEMHRS2009-07-13
547231885872706K090983APTUS 2.0/2.3 FOUR CORNER FUSION PLATEHRS2009-07-01
3093711885872706K090983APTUS 2.0/2.3 FOUR CORNER FUSION PLATEHRS2009-07-01
547231219861555K090053APTUS 2.0 RADIAL HEAD SYSTEMHRS2009-04-23
3093711219861555K090053APTUS 2.0 RADIAL HEAD SYSTEMHRS2009-04-23
99171978097481K083123MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIESGEX2009-11-24
99171409078299K072023ELLIPSE JUVIA, MODEL 9EJU7465GEX2007-09-12
547231312374119K071612MODUS TRILOCK 2.0/2.3/2.5JEY2007-09-11
547231083597711K052061MODUS IMF SCREWS 2.0DZE2005-10-21
547232029622556K051946MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEMMQN2005-08-22
547231568068573K051567APTUS TITANIUM OSTEOSYNTHESIS SYSTEMHRS2005-08-23
3093711568068573K051567APTUS TITANIUM OSTEOSYNTHESIS SYSTEMHRS2005-08-23
547231019063960K050934MODUS TITANIUM OSTEOSYNTHESIS SYSTEMJEY2005-05-05
99171255150674K000503MEDART 520 COOLING SYSTEMGEX2000-05-15
3093711031951465
3093711086672818
3093711100362001
3093711117611488
3093711133894504
547231246715792
3093711246715792
3093711301898362
3093711302976132
3093711314003268
3093711321133318
3093711327422197
3093711329115803
3093711339417164
3093711356845916
3093711359481101

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS582026-03-16
GEX202025-06-12
HWC102026-04-17
JDR62023-08-30
JEY42007-09-11
HTY22009-09-23
NGX12023-09-06
DZE12005-10-21
MQN12005-08-22

PMN#

52 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next