FDA.report

ARTHREX, INC.

Matched from indexed company URL: Arthrex Inc.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
12202461220246ARTHREX, INC.1N2026-01-011370 Creekside Blvd Naples FL US 34108
30025791363002579136Arthrex GmbH1N2026-01-01Erwin-Hielscher-Strasse 9 Munich Bavaria DE 81249
30069906003006990600Arthrex California Technology, Incorporated1N2026-01-01460 Ward Dr Santa Barbara CA US 93111
30071935053007193505ARTHREX GMBH1N2026-01-01Oskar-von-Miller Strasse 6 Odelzhausen Bavaria DE 85235
30094231123009423112Arthrex Logistic Center1Y2026-01-0114550 Plantation Road Fort Myers FL US 33912
30103316453010331645Arthrex, Inc.1N2026-01-016875 Arthrex Commerce Drive Ave Maria FL US 34142
30124703223012470322Arthrex Japan G.K. (Shinjuku)1N2026-01-01Shinjuku NS BLDG 28F 2-4-1 Nishi-Shinjuku Shinjuku-ku Tokyo JP 1630828
30140043493014004349Arthrex Singapore Pte Ltd.1N2026-01-0121 Biopolis Road Nucleos North Tower Unit 03-08 Singapore Central Singapore SG 138567
30142626933014262693Arthrex (Shanghai) Co., Ltd.1N2026-01-012205-2208 Garden Square 968 Beijing West Road Shanghai CN 200041
30152317893015231789Arthrex Manufacturing Inc.1N2026-01-01130 Arthrex Drive Pendleton SC US 29670
30168513793016851379Arthrex Distribution Hub EMEA B.V.1N2026-01-01Amperestraat 9 Venlo Limburg NL 5928 PE
30309269593030926959Arthrex Logistic Center Canada1N2026-01-01580 Sovereign Road London Ontario CA N5V 4K7
30312386463031238646Arthrex Medical Device (Shanghai) Co. Ltd.1N2026-01-01Room C212, 2/F, West Sub-Building (Building C), Block 3, No. 88, Shanghai CN 200131
20289191000142681ARTHREX CALIFORNIA, INC.1N2020-04-25168 Brea Canyon Road Walnut CA US 91789

GUDID Contact Samples

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

Source GUDIDProductPhoneEmail
00888867529823Arthrex® - FibuLock® PRO Guidewire, 2.0 x 200mm 2PK+1(800)934-4404complaints@arthrex.com
00888867531666Arthrex® - FibuLock® PRO Reamer, Long Cann 3.2 STRL+1(800)934-4404complaints@arthrex.com
00888867532212Arthrex® - 3.8x65mm Headless FibuLock® Scrw, SS, STR+1(800)934-4404complaints@arthrex.com
00888867532281Arthrex® - FibuLock® PRO Buttress Plate, 2H, STER+1(800)934-4404complaints@arthrex.com
00888867532380Arthrex® - FibuLock® PRO Buttress Plate, 3H, STER+1(800)934-4404complaints@arthrex.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
14761213657564K991971ARTHREX CHONDRAL DART, MODEL AR-4005B-18HTY2000-08-04
1593661213657564K991971ARTHREX CHONDRAL DART, MODEL AR-4005B-18HTY2000-08-04
2333621213657564K991971ARTHREX CHONDRAL DART, MODEL AR-4005B-18HTY2000-08-04
14761172069684K990987BIO-ABSORBABLE CORKSCREW, MODEL AR-1920BMAI2000-01-13
1593661172069684K990987BIO-ABSORBABLE CORKSCREW, MODEL AR-1920BMAI2000-01-13
2333621172069684K990987BIO-ABSORBABLE CORKSCREW, MODEL AR-1920BMAI2000-01-13
14761496666919K983843BIO-BUTTON 6.5MM, BIO-BUTTON 8MM, MODEL #'S AR-2236B & AR-2238BMAI1999-03-12
2913621496666919K983843BIO-BUTTON 6.5MM, BIO-BUTTON 8MM, MODEL #'S AR-2236B & AR-2238BMAI1999-03-12
2963131496666919K983843BIO-BUTTON 6.5MM, BIO-BUTTON 8MM, MODEL #'S AR-2236B & AR-2238BMAI1999-03-12
14761526523718K983577ARTHREX MENISCAL DART SYSTEMMAI1999-08-13
1593661526523718K983577ARTHREX MENISCAL DART SYSTEMMAI1999-08-13
2333621526523718K983577ARTHREX MENISCAL DART SYSTEMMAI1999-08-13
14761415905884K982743DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER, MODEL #'S SB 313 PB, SB 313 PBHGEI1998-09-14
2913621415905884K982743DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER, MODEL #'S SB 313 PB, SB 313 PBHGEI1998-09-14
2963131415905884K982743DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER, MODEL #'S SB 313 PB, SB 313 PBHGEI1998-09-14
14761329191466K981187ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001HWC1998-07-01
1593661329191466K981187ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001HWC1998-07-01
2333621329191466K981187ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001HWC1998-07-01
14761803359182K9748475.0MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22255, 3.5MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22235MBI1998-08-06
1593661803359182K9748475.0MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22255, 3.5MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22235MBI1998-08-06
2333621803359182K9748475.0MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22255, 3.5MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22235MBI1998-08-06
14761312915195K973812ARTHREX PUDDU OSTEOTOMY SYSTEMHRS1998-06-10
2333621312915195K973812ARTHREX PUDDU OSTEOTOMY SYSTEMHRS1998-06-10
2913621312915195K973812ARTHREX PUDDU OSTEOTOMY SYSTEMHRS1998-06-10
14761196806715K971723FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM)MBI1997-07-30
2333621196806715K971723FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM)MBI1997-07-30
2913621196806715K971723FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM)MBI1997-07-30
2963131196806715K971723FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM)MBI1997-07-30
14761232689819K971358BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MMMAI1997-07-09
1593661232689819K971358BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MMMAI1997-07-09
2333621232689819K971358BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MMMAI1997-07-09
14761201265194K961228KARL STORZ MAGNIFYING ARTHROSOCPESHRX1996-10-10
1388121201265194K961228KARL STORZ MAGNIFYING ARTHROSOCPESHRX1996-10-10
1772941201265194K961228KARL STORZ MAGNIFYING ARTHROSOCPESHRX1996-10-10
2913621201265194K961228KARL STORZ MAGNIFYING ARTHROSOCPESHRX1996-10-10
14761753137371K960516FASTAK SUTURE ANCHORMBI1996-04-18
1593661753137371K960516FASTAK SUTURE ANCHORMBI1996-04-18
2333621753137371K960516FASTAK SUTURE ANCHORMBI1996-04-18
14761645285625K945426ARTHREX CANCELLOUS SCREW AND WASHERHWC1995-04-14
1593661645285625K945426ARTHREX CANCELLOUS SCREW AND WASHERHWC1995-04-14
2333621645285625K945426ARTHREX CANCELLOUS SCREW AND WASHERHWC1995-04-14
14761440578319K945303ARTHREX BIOABSORBABLE INTERFERENCE SCREWHWC1996-01-25
1593661440578319K945303ARTHREX BIOABSORBABLE INTERFERENCE SCREWHWC1996-01-25
2333621440578319K945303ARTHREX BIOABSORBABLE INTERFERENCE SCREWHWC1996-01-25
14761370672514K943492ARTHREX STAPLESJDR1995-02-01
1388121370672514K943492ARTHREX STAPLESJDR1995-02-01
1771801370672514K943492ARTHREX STAPLESJDR1995-02-01
1772941370672514K943492ARTHREX STAPLESJDR1995-02-01
2913621370672514K943492ARTHREX STAPLESJDR1995-02-01
2962711370672514K943492ARTHREX STAPLESJDR1995-02-01
2963131370672514K943492ARTHREX STAPLESJDR1995-02-01
14761508377083K943154KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHSHRX1994-12-06
1388121508377083K943154KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHSHRX1994-12-06
1772941508377083K943154KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHSHRX1994-12-06
2913621508377083K943154KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHSHRX1994-12-06
14761943372863K941541HSV LAPAROSCOPY SETGCJ1994-05-16
1772941943372863K941541HSV LAPAROSCOPY SETGCJ1994-05-16
2913621943372863K941541HSV LAPAROSCOPY SETGCJ1994-05-16
2962711943372863K941541HSV LAPAROSCOPY SETGCJ1994-05-16
2963131943372863K941541HSV LAPAROSCOPY SETGCJ1994-05-16
3255051943372863K941541HSV LAPAROSCOPY SETGCJ1994-05-16
3275371943372863K941541HSV LAPAROSCOPY SETGCJ1994-05-16
14761044046155K934327ARTHREX SUTURE ANCHOR SCREW SYSTEMMBI1995-09-15
1593661044046155K934327ARTHREX SUTURE ANCHOR SCREW SYSTEMMBI1995-09-15
2333621044046155K934327ARTHREX SUTURE ANCHOR SCREW SYSTEMMBI1995-09-15
14761635148370K932699ARTHREX AR-8200 SHAVER SYSTEMHWE1994-01-25
1772941635148370K932699ARTHREX AR-8200 SHAVER SYSTEMHWE1994-01-25
2913621635148370K932699ARTHREX AR-8200 SHAVER SYSTEMHWE1994-01-25
2962711635148370K932699ARTHREX AR-8200 SHAVER SYSTEMHWE1994-01-25
2963131635148370K932699ARTHREX AR-8200 SHAVER SYSTEMHWE1994-01-25
3275371635148370K932699ARTHREX AR-8200 SHAVER SYSTEMHWE1994-01-25
2963131173826867K921119ARTHREX ARTHROSCOPEHRX1994-04-15
14761173826867K921119ARTHREX ARTHROSCOPEHRX1994-04-15
1772941173826867K921119ARTHREX ARTHROSCOPEHRX1994-04-15
14761512532981K915721MODEL AR-6300 INFUSION PUMPHRX1992-03-19
1772941512532981K915721MODEL AR-6300 INFUSION PUMPHRX1992-03-19
2913621512532981K915721MODEL AR-6300 INFUSION PUMPHRX1992-03-19
2963131512532981K915721MODEL AR-6300 INFUSION PUMPHRX1992-03-19
2963131666311898K915424ARTHREX CANNULATED INTERFERENCE SCREWHWC1993-02-09
14761666311898K915424ARTHREX CANNULATED INTERFERENCE SCREWHWC1993-02-09
2913621666311898K915424ARTHREX CANNULATED INTERFERENCE SCREWHWC1993-02-09
14761235537325K901035FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLEFST1990-04-23
2963131235537325K901035FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLEFST1990-04-23
3255051235537325K901035FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLEFST1990-04-23
3275371235537325K901035FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLEFST1990-04-23
3275371625322811K882958SONY VIDEO PRINTERS, UP SERIESKQM1988-08-04
14761686459874K792558CONTAINER SYSTEMFLE1979-12-27
1772941686459874K792558CONTAINER SYSTEMFLE1979-12-27
2913621686459874K792558CONTAINER SYSTEMFLE1979-12-27
14761475185656K260561Arthrex FiberTak Suture AnchorMBI2026-03-20
14761266309140K260405FiberTape ButtonMBI2026-03-09
14762018240914K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonHRS2026-03-03
14761364170554K254229Arthrex Nano FiberTak Suture AnchorMBI2026-03-02
14761099428066K254215Arthrex Beaming SystemHWC2026-05-08
14761573817328K253931
14761974207204K253895Arthrex SwiveLock Suture Anchor, 3.5 x 10 mmMBI2025-12-30
14761735370218K253727Syndesmosis TightRope PROHTN2025-12-22
14761737554326K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemHRS2026-01-21
14761047719926K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesHRS2026-01-12
14761963558779K252314Arthrex SutureTak Suture AnchorMBI2025-10-29
1662791963558779K252314Arthrex SutureTak Suture AnchorMBI2025-10-29
14762043741607K252196Arthrex FibuLock Nail SystemHSB2026-03-05
14761015326767K252016Arthrex Humeral NailsHSB2026-03-20
14762058591559K251994Arthrex Synergy Vision Imaging SystemGCJ2025-10-16
1662792058591559K251994Arthrex Synergy Vision Imaging SystemGCJ2025-10-16
14761970689577K251809Arthrex FiberTak Suture AnchorMBI2025-07-18
14761375106784K251690Arthrex SpeedFLEX™ ImplantOWY2025-09-30
14761485789776K251453Arthrex iBalance Partial Knee SystemHSX2025-07-01
14761637067192K251145Arthrex PushLock Suture AnchorsMBI2025-07-10
14761786842472K250920Arthrex Spine Compression FT ScrewMRW2025-05-22
14761107746871K250728Arthrex Synergy Vision Endoscopic Imaging SystemGCJ2025-05-05
14761919878028K250596Arthrex FiberTak Suture AnchorMBI2025-03-28
14761088536452K250526Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture AnchorMAI2025-03-14
14761875494070K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)KTT2025-08-08
14761160847897K250424Arthrex TightRope Soft Button, RTMBI2025-03-11
14761113423798K243995Arthrex Humeral Plating System and Cerclage ButtonHRS2025-03-26

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
MBI1792026-03-20
HRS1752026-03-03
HWC1602026-05-08
MAI1582025-03-14
KWS772023-09-26
GAT682022-10-27
HTN662025-12-22
GCJ582025-10-16
HTY482020-06-29
HSB452026-03-20
HRX422025-05-16
PHX382023-04-10
GEI282018-02-23
JDR192025-01-31
JWH192015-11-12
FMF192015-07-07
HSD182024-02-12
LLZ142020-04-30
MQV142011-01-10
KTT132025-08-08
HSX122025-07-01
FRO92018-12-10
MBH92017-11-07
QHE82024-10-02
KWD82007-01-03
PKC72020-11-20
HWE71994-01-25
JDQ62025-02-20
QHQ62019-07-26
KRR62016-04-12
HIF52016-03-04
KNW42021-11-19
DXJ42018-02-22
MNU42001-06-19
FST41990-04-23
KTW32017-06-22
PLF32015-08-12
GAS32010-07-30
FRG32006-02-15
LZB32005-11-29

PMN

200 records. Showing 1-40. Next

GUDID

200 records. Showing 1-40. Next