53 results
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46ms
·
Sources: EU EUDAMED, US FDA
Stat-A-Dyne Ankle
FDA UDI
LANTZ MEDICAL, INC.·B770AN0·Orthosis providing flexion and extension of ankle
Stat-A-Dyne WHFO
FDA UDI
LANTZ MEDICAL, INC.·B770WH0·Orthosis providing flexion and extension of wri...
Stat-A-Dyne Wrist
FDA UDI
LANTZ MEDICAL, INC.·B770WR0·Orthosis providing flexion and extension of wrist
Stat-A-Dyne Elbow
FDA UDI
LANTZ MEDICAL, INC.·B770EL0·Orthosis providing flexion and extension of elbow
Vector 1
FDA UDI
LANTZ MEDICAL, INC.·B770VEC0·Exerciser to increase flexion and the extension...
Stat-A-Dyne ESP
FDA UDI
LANTZ MEDICAL, INC.·B770ES0·Orthosis providing flexion, extension, pronatio...
Stat-A-Dyne Pro/Sup
FDA UDI
LANTZ MEDICAL, INC.·B770PS0·Orthosis providing dynamic and/or static pronat...
Stat-A-Dyne Knee
FDA UDI
LANTZ MEDICAL, INC.·B770KN0·Orthosis providing flexion and extension of knee
Stat-A-Dyne Shoulder
FDA UDI
LANTZ MEDICAL, INC.·B770SH0·Orthosis providing flexion and extension of sho...
LANTIS software with MedOnc Module; MedOnc module is an option of the LANTIS radiotherapy treatment planning software distributed as a component of the firm''s linear accelerator used to deliver radiation therapy to cancer patients. The MedOnc module is distributed by Siemens Medical Solutions USA Oncology Division, 4040 Nelson Avenue, Concord, CA 94520 with their linear accelerators software package called LANTIS. The MedOnc module option is distributed with all LANTIS software copies, but the module must be turned on by an electronic key that is purchased by individual hospitals. Siemens Medical Solutions USA purchases the LANTIS software (code) from IMPAC Medical Systems, Inc., 100 West Evelyn Avenue, Mountain View, CA 94041 (REG#2950347, FEI: 1000123805). IMPAC distributes the same software under the name SEQUENCER.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·January 6, 2005
Siemens LANTIS 6.1 Oncology Information System with MEDOne Module, Linear Medical Accelerators; Product Numbers: 4503178, 5835991, 5851055; Product is manufactured by IMPAC Medical, Inc., Sunnyvale, CA. Medical charged-particle radiation therapy system.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·March 6, 2009
LANTIS oncology Information System, an accessory to the Linear Accelerator, as part of the COHERENCE RT Therapist, but also cleared under the ONCOR Avante-Garde and Expression, as well as the syngo RT Therapist system, as part of the ARTISTE And PRIMUS system. Manufactured by IMPAC Medical Inc., Sunnyvale, CA, device distributed by Siemens Medical Solutions Oncology Care System, Concord, CA Electronic record management system as part of a linear accelerator system used to keep track of notes and database for oncology electronic medical records.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·August 21, 2009
Siemens ARTISTE syngo RT Therapist, Therapist Assist, Therapist Express Basic, and Therapist Express Assist Systems, manufactured by Siemens Medical Solutions, Concord, CA
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·September 10, 2009
ST-AIA PACK LH II; Part Number: 025296 Assay, Reproductive Hormone
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code CEP·March 5, 2018
ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code LTJ·March 5, 2018
ST-AIA PACK 27.29; Part Number: 025202 Assay, Tumor Marker
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code MOI·March 5, 2018
ST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive Hormone
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code CHP·March 5, 2018
ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney Marker
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code NDY·March 5, 2018
ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code NIG·March 5, 2018
ST-AIA PACK Prog II; Part Number: 025239 Assay, Reproductive Hormone
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code JLS·March 5, 2018