FDA.reportPublic FDA data

MEDART ApS

Matched from indexed company URL: MEDA LTD.

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
30057989633005798963MEDAIRE, INC.1Y2026-01-0123610 N 20th Dr Ste 10 PHOENIX AZ US 85085
30065400523006540052MEDA CO., LTD.1N2026-01-01F2C, F3D, F4C, F5, F6C, Building C2, Xinmao Science Skill Park Huayuan Industry Development Area Tianjin CN 300384
30066399163006639916Medacta USA, Inc.1Y2026-01-016386 Global Drive, Suite 101 Memphis TN US 38141
30072194013007219401MEDAGENT, INC.1Y2026-01-01264 Lafayette Road, Suite 7 Portsmouth NH US 03801
30081105333008110533MEDACTA INTERNATIONAL SA1N2026-01-01Via Alla Rossa 6 Rancate Ticino CH 6862
30095407493009540749Medartis Inc.1Y2026-01-011195 Polk Drive Warsaw IN US 46582
30105153773010515377MEDACURE INC1Y2026-01-011274 - 49th Street Suite # 28 Brooklyn NY US 11219
30120504233012050423MEDAS, INC.1N2026-01-0120855 NE 16TH Avenue C21 Miami FL US 33179
30141188213014118821MEDAXIS AG1N2026-01-01Bahnhofstrasse 9 Baar Zug CH 6340
30151901763015190176MEDALLIANCE, LLC1N2026-01-014 Jenner Suite 190 Irvine CA US 92618
30297790463029779046Medasense Biometrics Inc.1Y2026-01-012436 Emrick Boulevard Bethlehem PA US 18020
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
30131534053013153405MEDADENT LIMITED1N2020-04-2513 Hawley Crescent Work Life London United Kingdom GB NW1 8NP
30134049723013404972MEDAMONITOR, LLC1N2020-04-252040 15th Ave W Seattle WA US 98119

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
1986471162288759K974131ALERTEBF1997-12-17
2024091557798459K973477BIOSENSORS EMBOLECTOMY CATHETERDXE1998-09-04
1986471255302350K973199AMSINO SUCTION CATHETERBSY1997-09-10
1986471664224381K970715SYSTEM B HEAT SOURCEEAT1997-04-07
1916901793527062K964402VERSATRAC (TM) LUMBAR RETRACTOR SYSTEMGZT1997-01-23
1986471601181557K961166FLOWTRON EXCEL PUMPJOW1996-10-11
1986471226329008K952662COMP=FLOWEBF1995-08-28
1986472052860216K950461WELCH ALLYN OPHTHALMOSCOPEHLI1995-04-04
1986471556546409K945200FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCESKOO1994-11-30
1986471891314422K940493HAND ANEROID SPHYGMOMANOMETERDXQ1994-07-01
1986471454854018K933872VISI-SPEAR EYE SPONGEHOZ1993-12-27
1986471086390026K912485COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILICELW1991-07-25
1986471774019517K911160MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305GEI1991-05-02
1986471176372923K884218AUDIOSCOPE 3 MODEL 23300 ACCESSORIESEWO1989-03-10
1986471480612454K881471KIMGUARD (REGULAR & HEAVY DUTY) STERILE WRAPFRG1988-08-10
1986471064875834K861516WELCH ALLYN TYMPANOMETERETY1986-06-10
1986471182226884K861005GLASIONOMER BASE CEMENTEMA1986-04-25
1986471284290998K842115SPUNGARD & SURG. DRAPES-GOWNS & PACKSKKX1984-06-11
1986471619695294K840229CONTROL COVER GOWNFYC1984-03-19
1986471034515922K810227MODEL #53110 DISPOSABLE ANOSCOPEFER1981-02-19
1916901712692956K792558CONTAINER SYSTEMFLE1979-12-27
1986471008818807K790610SIGMOIDOSCOPE TIPLESSFAM1979-04-23
1986471022919878K782079ELECTRODE SYSTEM, QUIK-PREPDRX1979-02-01
1986471437792224K781682SURGICAL GOWNS & DRAPESFYA1978-12-20
1986471813215502K771189HOT TEMP CAUTERYHQP1977-07-11
1916902021608984K261016
547231096607092K260934TITAN Nail; APTUS K-Wire SystemHWC2026-04-17
1916901840136140K254202MectaLIF 3D Metal AnteriorOVD2026-05-05
1916901506951870K253940M.U.S.T. Pedicle Screw System - ExtensionNKB2026-04-28
547231860272886K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5HRS2026-03-16
3093711860272886K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5HRS2026-03-16
1916901741856408K253328GMK 3D Metal Tibial Tray ExtensionMBH2026-02-26
1916901666747391K252847NextAR Hip PlatformSBF2026-01-09
1916901793311281K252225PowerKnot High Strength SuturesGAT2025-09-12
1916901515472498K251933SnugFit ASA ExtensionMBI2025-07-01
1916901194423170K251737NextAR(TM) Shoulder PlatformSBF2025-09-04
1916901850359741K251618MOTO Partial Knee System ExtensionHSX2025-07-24
1916902012348631K251166Mfinity Femoral SystemMEH2025-06-13
1916901363324227K251043Mpact 3D Metal Implants Extension – DMLS TechnologyLPH2026-01-28
1916901114681460K251016MectaLIF 3D MetalMAX2025-07-17
3381991471655220K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)GEX2025-06-12
1916901143132866K250644MSS - Monobloc stemPHX2026-02-03
1916901330051494K250477NextAR(TM) SpineSBF2025-07-31
1916901560483065K250450Coated hip implantsLZO2025-09-19
1916901984373453K250338MSS - Humeral reverse liners extensionPHX2025-10-31
1916901142561737K243697MySpine WebPlannerLLZ2025-04-23
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
1916901014241615K242603MyPAO SA guidesPBF2025-11-19
1916901556226418K242232Mpact 3D Metal Augments IILPH2025-04-23
1916902059652684K241767Versacem Acetabular Shell and Double Mobility HC LinersLZO2025-03-06
2024091987099392K241581Hemodialysis CatheterMSD2025-05-16
1916901233312966K241461Mpact Constrained LinerKWZ2025-07-31
1916901591546218K241292MyShoulder Planner (5.3SSWPL)KWS2025-01-30
1916901561120376K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemPML2024-06-12
547231354065185K240613APTUS Elbow Dorsal Olecranon PlatesHRS2024-06-20
3093711354065185K240613APTUS Elbow Dorsal Olecranon PlatesHRS2024-06-20
547231997780283K234062APTUS Hand Scaphoid PlatesHRS2024-03-21
1916901535956576K234048M.U.S.T. Pedicle Screw System - ExtensionNKB2024-02-13
3381991759449455K233416Cryojet Plus (SHE-ACP001-1)GEX2024-02-06
1916901820643043K233172NextAR™ Spine PlatformSBF2024-04-24
1916901858514797K232733Mbrace CableJDQ2024-05-03
1916901816346930K232513X-Twist Biocomposite Suture AnchorMAI2023-09-18
3093711368569290K232324StealthFix Intraosseous Fixation SystemJDR2023-08-30
1916901676802230K232280NextAR™ TSA PlatformSBF2023-10-29
547231356334431K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionHWC2023-11-03
547231879027036K232144Sterile Products of the APTUS SystemHRS2023-08-18
1916901810011714K232123MectaLIF Anterior Lag ExtensionOVD2023-10-18
547231615120149K232105APTUS Foot System 2.8-3.5HRS2024-04-19
1916901184518815K231911Glenoid Reconstruction System – Full Wedge BaseplatePHX2023-11-09
1916901619903565K231515MySpine Cervical GuidesQSD2023-12-07
1916901967788922K231483MySpine Unilateral GuidesPQC2023-07-21
1916901686793769K231037MyKnee UNI-STJWH2023-06-09
547231656496776K230971APTUS® 3.5 TriLock Straight PlatesHRS2023-06-02
1916901692988058K230891SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair ImplantMBI2023-12-28
1916901976485643K230544SnugFit All-Suture Anchor extensionMBI2023-04-17
1916901294897064K230394EUROSCREW NG; EUROSCREW TCP NGMAI2023-05-12
3381991706986935K230024HI-EMT MAGSHAPENGX2023-09-06
1916901802496929K230011Mpact ExtensionLPH2023-09-20
547231890044055K223853Medartis APTUS® Ulna PlatesHRS2023-03-30
1916902054510783K223795FairFix QT Adjustable ButtonMBI2023-01-17
1916901745330689K223769NextAR™ Spine PlatformSBF2023-07-21
1916901035742154K223582MectaLock TI Triple Loaded Suture AnchorMBI2023-02-24
1916901790377907K223548GMK Sphere & GMK SpheriKA CementlessMBH2023-01-20
1916901108271619K222169FairFix Adjustable Button SystemMBI2022-08-16
1916901046097886K221850GMK 3D Metal Tibial TrayMBH2022-08-23
1916901982153315K221725Advanced MyHip PlannerLLZ2023-01-20
1916901703639869K221545MectaLIF Anterior ExtensionOVD2022-10-24
1916901640959506K221502Parcus Synd-EZ SSMBI2022-07-26
1916901112715039K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMBI2022-06-08
1916901297225332K221135X-Twist PEEK Suture AnchorMBI2022-05-19
1916902005688164K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesQSR2022-05-24
1916901059604261K220706MyPAO GuidesPBF2023-05-30
1916901496805995K220705MyKnee R Pin PositionersJWH2022-05-04
1916901062448587K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionNKG2022-04-26
1916901409869415K220405Amis K LongLZO2022-04-12
3093711707440951K220181StealthFix Intraosseous Fixation SystemJDR2022-03-22
1916902005861314K213751NextAR™ TKA Platform My Knee PPSSBF2022-03-10
1916901904836041K213459Glenoid Reconstruction SystemPHX2022-11-23
1916901346794744K213071MOTOTM Partial Knee & MOTO PFJ Systems ExtensionHSX2021-11-16
795331774669056K213070MD-320W Ultrasound BiomicroscopeIYO2021-11-18
3093711401906119K212979CalcShift™ Displacement Calcaneal Osteotomy SystemHRS2022-05-20
1916901446942908K212831MectaLIF ExtensionMAX2021-10-29
1916901190736494K212739ActiFlipMBI2021-10-06
1916901151770760K212327M-Vizion MonoblocLZO2022-05-24
1916901401514551K211891DM Converter - TiN coatedLZO2022-07-22
1916901593555485K211664GMK Sphere RevisionJWH2021-07-29
1916901577180324K211435PAO Cortical ScrewHWC2021-08-06
2024092053313042K211393Selethru(TM) NC PTCA Balloon Dilatation CatheterLOX2021-07-02

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS582026-03-16
MBI502025-07-01
LZO482025-09-19
JWH322023-06-09
GEX202025-06-12
HWC192026-04-17
PHX192026-02-03
NKB142026-04-28
LPH122026-01-28
SBF112026-01-09
MAX112025-07-17
NKG102022-04-26
OVD82026-05-05
KGO82014-06-04
JDR72023-08-30
HSX62025-07-24
IYO62021-11-18
LLZ52025-04-23
MAI52023-09-18
PQC52023-07-21
KRO52021-03-02
OUR52021-01-13
DYB42018-03-02
ODP42017-09-18
MEG42016-08-19
LZA42012-03-09
EBF42009-10-30
JEY42007-09-11
FRG42006-02-15
MBH32026-02-26
GAT32025-09-12
MEH32025-06-13
KWS32025-01-30
OVE32020-11-06
KIF32016-07-27
FOZ32015-06-18
EZL32014-12-15
ELW32012-05-22
KKX32010-11-09
JDI32008-12-29

NDC#

PMN#

200 records. Showing 1-40. Next

Applications#

GUDID#

80 records. Showing 1-40. Next