FDA.reportPublic FDA data

DJO GLOBAL SWITZERLAND SARL

Matched from indexed company URL: DJO, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30036789583003678958DJO GLOBAL SWITZERLAND SARL1N2026-01-01ZI Larges Pieces A Chemin du Devent Ecublens Vaud CH CH-1024
30076154363007615436DJO Tunisie1N2026-01-01Zone Industrielle Poudriere 1 Rue 13 Aout, SFAX TN 3000
30077405913007740591DJO Global / Germany1N2026-01-01ORMED GmbH Boetzinger Strasse 90 Freiburg Baden-Wurttemberg DE 79111
30124469702020737DJO, LLC1N2026-01-013151 Scott St Vista CA US 92081
30146943773014694377DJO, LLC1N2026-01-013300 Eagle Parkway Fort Worth TX US 76177
30172642443017264244DJO, LLC1Y2026-01-015919 Sea Otter Place Suite 200 Carlsbad CA US 92010
20207372020737DJO, LLC1Y2020-04-251430 Decision St VISTA CA US 92081

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
156131477441075P910066ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATORLOF1994-03-04
2040251477441075P910066ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATORLOF1994-03-04
2770101477441075P910066ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATORLOF1994-03-04
2040251679515520P210016ManaFuseLOF2025-01-17
2770101679515520P210016ManaFuseLOF2025-01-17
2040251396776772P080028STORZ MEDICAL DUOLITH SD1 SHOCK WAVE THERAPYNBN2016-01-08
156131657358823K992454VENAFLOW SYSTEM, MODEL 30AJOW2000-01-13
2040251657358823K992454VENAFLOW SYSTEM, MODEL 30AJOW2000-01-13
2770101657358823K992454VENAFLOW SYSTEM, MODEL 30AJOW2000-01-13
156131743275515K983484DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODEEGJ1998-12-28
2770101743275515K983484DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODEEGJ1998-12-28
156131368846529K983206SMALL VAGINAL/RECTAL ELECTRODEKPI1998-11-03
2770101368846529K983206SMALL VAGINAL/RECTAL ELECTRODEKPI1998-11-03
156131810674408K982828FORTE, MODELS CPS 400 STIM, CPS 200 STIMIPF1998-11-06
2770101810674408K982828FORTE, MODELS CPS 400 STIM, CPS 200 STIMIPF1998-11-06
156131219969974K982668PHORESOR II,MODEL PM900EGJ1999-03-02
2770101219969974K982668PHORESOR II,MODEL PM900EGJ1999-03-02
156131850452682K982410SMP-PLUS,SX-PLUS,SX MODEL # 49XX SERIES 9 VOLT TENS DEVICEGZJ1998-11-06
2770101850452682K982410SMP-PLUS,SX-PLUS,SX MODEL # 49XX SERIES 9 VOLT TENS DEVICEGZJ1998-11-06
156131660438038K974855PHORESOR II, MODEL PM900KTB1998-03-27
2770101660438038K974855PHORESOR II, MODEL PM900KTB1998-03-27
156131120461298K973024INTELECT LEGEND ULTRASOUNDIMI1997-11-10
2770101120461298K973024INTELECT LEGEND ULTRASOUNDIMI1997-11-10
156131148167878K972054INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODEKPI1997-08-14
2770101148167878K972054INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODEKPI1997-08-14
156131399065420K971542ORTHO DX NEUROMUSCULAR STIMULATORIPF1997-08-14
2770101399065420K971542ORTHO DX NEUROMUSCULAR STIMULATORIPF1997-08-14
156131617137642K970426VALUETRODEGXY1997-05-09
2770101617137642K970426VALUETRODEGXY1997-05-09
156131145579875K970307MINNOVA PELVIC FLOOR STIMULATION SYSTEMKPI1997-04-22
2770101145579875K970307MINNOVA PELVIC FLOOR STIMULATION SYSTEMKPI1997-04-22
156131501440770K964238AIRCAST VENA FLOW STERILE DISPOSABLE CUFFSJOW1997-09-08
2770101501440770K964238AIRCAST VENA FLOW STERILE DISPOSABLE CUFFSJOW1997-09-08
156131804617560K96377324457-010 SECURE ALL PELVIC HOLDER/24458-010 SECURE ALL BODY BELTFMQ1996-11-21
2770101804617560K96377324457-010 SECURE ALL PELVIC HOLDER/24458-010 SECURE ALL BODY BELTFMQ1996-11-21
156131193182373K963564PERSONAL LIMB HOLDER (24444-200,300,24444-KIT)FMQ1996-11-22
2770101193182373K963564PERSONAL LIMB HOLDER (24444-200,300,24444-KIT)FMQ1996-11-22
156131900396350K963563ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145)FMQ1996-11-21
2770101900396350K963563ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145)FMQ1996-11-21
156131895747133K963561ULTRA CARE VEST STYLE BODY HOLDER, SMALL (24455-010,020,030,040,24456-010,020,030,040)FMQ1996-11-21
2770101895747133K963561ULTRA CARE VEST STYLE BODY HOLDER, SMALL (24455-010,020,030,040,24456-010,020,030,040)FMQ1996-11-21
156131655492109K963559WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010)FMQ1996-11-22
2770101655492109K963559WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010)FMQ1996-11-22
156131795101761K963557SYSTEM 2 ZIPPERED BODY HOLDER, SMALL/MEDIUM 24453-010,24453-020,24453-030FMQ1996-11-21
2770101795101761K963557SYSTEM 2 ZIPPERED BODY HOLDER, SMALL/MEDIUM 24453-010,24453-020,24453-030FMQ1996-11-21
156131805991656K963556SECURE-ALL 1-PIECE BODY HOLDER, SMALL/MEDIUM (24451-010,020,24452-010,020,030)FMQ1996-11-21
2770101805991656K963556SECURE-ALL 1-PIECE BODY HOLDER, SMALL/MEDIUM (24451-010,020,24452-010,020,030)FMQ1996-11-21
156131370368452K96355424448-010 SECURE-ALL FINGER CONTROL MITTFMQ1996-11-21
2770101370368452K96355424448-010 SECURE-ALL FINGER CONTROL MITTFMQ1996-11-21
156131218296318K963552QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350)FMQ1996-11-22
2770101218296318K963552QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350)FMQ1996-11-22
156131471288124K963492PROTECTIVE RESTRAINTFMQ1996-11-12
2770101471288124K963492PROTECTIVE RESTRAINTFMQ1996-11-12
156131421314926K963490PROTECTIVE RESTRAINT - BELTSFMQ1996-11-12
2770101421314926K963490PROTECTIVE RESTRAINT - BELTSFMQ1996-11-12
156131053358755K963489WHEEL CHAIR ACCESSORYFMQ1996-11-12
2770101053358755K963489WHEEL CHAIR ACCESSORYFMQ1996-11-12
156131166287935K954126TRANSQ ELECTRODE PHORESOR IIKTB1996-01-19
2770101166287935K954126TRANSQ ELECTRODE PHORESOR IIKTB1996-01-19
156131549833520K943898SAUNDERS ELECTRONIC INCLINOMETERKQX1994-11-28
2770101549833520K943898SAUNDERS ELECTRONIC INCLINOMETERKQX1994-11-28
156131636745644K941389EMPI TAPE PATCHESKGX1994-08-23
2770101636745644K941389EMPI TAPE PATCHESKGX1994-08-23
156131300874668K934335PHORESOR II AUTO, MODEL PM800 MODIFICATIONEGJ1994-07-26
2770101300874668K934335PHORESOR II AUTO, MODEL PM800 MODIFICATIONEGJ1994-07-26
156131171402349K932900AIRCAST VENAFLOW SYSTEMJOW1993-10-25
2770101171402349K932900AIRCAST VENAFLOW SYSTEMJOW1993-10-25
156131524263335K932621RH-801/GS MODEL TRANSQ(R)1EGJ1994-07-26
2770101524263335K932621RH-801/GS MODEL TRANSQ(R)1EGJ1994-07-26
156131357972726K932620RH-806/GS MODEL TRANSQ(R)2EGJ1994-07-26
2770101357972726K932620RH-806/GS MODEL TRANSQ(R)2EGJ1994-07-26
156131517505046K925806RH-801, MODEL TRANSQEGJ1994-07-14
2770101517505046K925806RH-801, MODEL TRANSQEGJ1994-07-14
156131579896850K925800RH-806, MODEL TRANSQEGJ1994-07-14
2770101579896850K925800RH-806, MODEL TRANSQEGJ1994-07-14
156131537688399K925643RX FIT MEDICAL STOCKINGSDWL1993-12-06
2770101537688399K925643RX FIT MEDICAL STOCKINGSDWL1993-12-06
156131408260179K921608PRESSSION, SEQUENTIALJOW1992-12-30
2770101408260179K921608PRESSSION, SEQUENTIALJOW1992-12-30
156131254067579K915444DUPEL IONTOPHORESIS DEVICEEGJ1994-07-15
2770101254067579K915444DUPEL IONTOPHORESIS DEVICEEGJ1994-07-15
156131571303048K915333ELECTRODE USING PROMEON RG-60 SERIES GELGXY1992-01-14
2770101571303048K915333ELECTRODE USING PROMEON RG-60 SERIES GELGXY1992-01-14
156131697367079K914621IONTOPHORESIS DEVICE, MODIFICATIONEGJ1991-12-20
2770101697367079K914621IONTOPHORESIS DEVICE, MODIFICATIONEGJ1991-12-20
156131962465042K914264TRANSQ 2EGJ1991-12-20
2770101962465042K914264TRANSQ 2EGJ1991-12-20
156131668725278K912015TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3EGJ1991-11-15
2770101668725278K912015TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3EGJ1991-11-15
156131117597300K902195TBD TENS REUSABLE ELECTRODEGXY1990-06-08
2770101117597300K902195TBD TENS REUSABLE ELECTRODEGXY1990-06-08
156131366113545K896817MODEL T11 FLUIDOTHERAPY UNITLSB1991-01-18
2770101366113545K896817MODEL T11 FLUIDOTHERAPY UNITLSB1991-01-18
156131320886037K896444IONTOPHORESIS DEVICE - ELECTRODE RH 800EGJ1990-05-10
2770101320886037K896444IONTOPHORESIS DEVICE - ELECTRODE RH 800EGJ1990-05-10
156131905664034K874469TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS)GXY1988-01-28
2770101905664034K874469TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS)GXY1988-01-28
156131859902315K873368TECNOL COMPRESSION KNEE DRESSINGLLK1987-12-11
2770101859902315K873368TECNOL COMPRESSION KNEE DRESSINGLLK1987-12-11
156131736041381K852267ELECTRICAL NERVE STIMULATION(TENS) ELECTRODESGXY1985-06-18
2770101736041381K852267ELECTRICAL NERVE STIMULATION(TENS) ELECTRODESGXY1985-06-18
156131714718155K840346NEUROMUSCLAR IIIPF1984-02-10
2770101714718155K840346NEUROMUSCLAR IIIPF1984-02-10
156131651534213K801272TECNOL QUICK RELEASE LIMB HOLDERFMQ1980-06-17
2770101651534213K801272TECNOL QUICK RELEASE LIMB HOLDERFMQ1980-06-17
156131904152536K790699TECNOL BODY HOLDERFMQ1979-06-01
2770101904152536K790699TECNOL BODY HOLDERFMQ1979-06-01
2251501230526788K202839Overlapped Compression TherapyJOW2021-01-21
2770101230526788K202839Overlapped Compression TherapyJOW2021-01-21
2770101938481998K201653Compex Sport Elite 3.0NGX2020-11-27
2770101828950974K200561StimPlus Patch, StimPlus Patch, StimPlus PatchNUH2020-07-01
2770101700205497K180865ZMI Self-Adhesive ElectrodesGXY2018-06-28
2770101003156025K173067LightForce LTS Model 1000, 1500, 2500, and 4000GEX2018-02-22
156131172537972K170918Compex Sport EliteNGX2017-06-20
1774061172537972K170918Compex Sport EliteNGX2017-06-20
2770101172537972K170918Compex Sport EliteNGX2017-06-20
156131267372505K170903Compex Wireless USANGX2017-06-19
2770101267372505K170903Compex Wireless USANGX2017-06-19
2040251128543612K162517Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13NUH2017-04-14
2770101636960237K160138Adhesive ElectrodesGXY2016-08-11

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EGJ322007-11-16
FMQ281996-11-22
IPF272016-04-14
JOW252021-01-21
NGX142020-11-27
GXY142018-06-28
KTB122003-12-22
GZJ102016-06-03
NUH62020-07-01
ITH62006-02-24
KPI61998-11-03
IMG42004-04-12
IMI42003-12-03
LSB42001-07-06
ILY32004-09-08
LOF31994-03-04
IMJ22009-03-18
KQX21994-11-28
KGX21994-08-23
DWL21993-12-06
LLK21987-12-11
GEX12018-02-22
NBN12016-01-08

PMA#

Scandinavian Total Ankle Replacement (STAR Ankle)

2022-09-29

DJO Global9800 Metric Boulevardaustin, TX 78758 PMA NumberP050050 Supplement NumberS025 Date Received09/02/2022 Decision Date09/29/2022 Product Code NTG  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufactu...

Scandinavian Total Ankle Replacement (STAR Ankle)

2022-03-11

DJO Global9800 Metric Boulevardaustin, TX 78758 PMA NumberP050050 Supplement NumberS022 Date Received02/01/2022 Decision Date03/11/2022 Product Code NTG  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufactu...

PMN#

GUDID#

200 records. Showing 1-40. Next