33 results
·
7ms
·
Sources: EU EUDAMED, US FDA
Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT).
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·April 17, 2013
Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat transfer and liposuction.
FDA Enforcement
Class II
·Terminated·Shippert Medical Technologies·November 29, 2017
Tissu-Trans FILTRON 2000, Catalog 3-TT-FILTRON 2000, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
FDA Enforcement
Class II
·Completed·Shippert Medical Technologies·May 22, 2019
Tissu-Trans FILTRON 1000, Catalog 3-TT-FILTRON 1000, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
FDA Enforcement
Class II
·Completed·Shippert Medical Technologies·May 22, 2019
Tissu-Trans Filtron 1000, 3-TT-FILTRON 1000. Product Usage: Intended for fat transfer and liposuction.
FDA Enforcement
Class II
·Terminated·Shippert Medical Technologies·August 30, 2017
Tissu-Trans Filtron 100, 3-TT-FILTRON 100. Product Usage: Intended for fat transfer and liposuction.
FDA Enforcement
Class II
·Terminated·Shippert Medical Technologies·August 30, 2017
Tissu-Trans SFILL 360, 3-TT-SFILL 360. Product Usage: Intended for fat transfer and liposuction.
FDA Enforcement
Class II
·Terminated·Shippert Medical Technologies·August 30, 2017
Tissu-Trans Filtron 2000, 3-TT-FILTRON 2000. Product Usage: Intended for fat transfer and liposuction.
FDA Enforcement
Class II
·Terminated·Shippert Medical Technologies·August 30, 2017
Tissu-Trans Filtron 250, 3-TT-FILTRON 250. Product Usage: Intended for fat transfer and liposuction.
FDA Enforcement
Class II
·Terminated·Shippert Medical Technologies·August 30, 2017
Tissu-Trans MEGA 1500, 3-TT-MEGA 1500. Product Usage: Intended for fat transfer and liposuction.
FDA Enforcement
Class II
·Terminated·Shippert Medical Technologies·August 30, 2017
Tissu-Trans Filtron 500, 3-TT-FILTRON 500. Product Usage: Intended for fat transfer and liposuction.
FDA Enforcement
Class II
·Terminated·Shippert Medical Technologies·August 30, 2017
Tissu-Trans Syringe Fill 360, Catalog 3-TT-SFILL 360, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
FDA Enforcement
Class II
·Completed·Shippert Medical Technologies·May 22, 2019
Tissu-Trans MEGA 1500, Catalog 3-TT-MEGA 1500, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
FDA Enforcement
Class II
·Completed·Shippert Medical Technologies·May 22, 2019
Tissu-Trans FILTRON 250, Catalog 3-TT-FILTRON 250, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
FDA Enforcement
Class II
·Completed·Shippert Medical Technologies·May 22, 2019
Tissu-Trans FILTRON 100, Catalog 3-TT-FILTRON 100, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
FDA Enforcement
Class II
·Completed·Shippert Medical Technologies·May 22, 2019
Tissu-Trans FILTRON 500, Catalog 3-TT-FILTRON 500, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
FDA Enforcement
Class II
·Completed·Shippert Medical Technologies·May 22, 2019
Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
FDA Enforcement
Class II
·Ongoing·Btt Health Gmbh·September 25, 2024
OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
FDA Enforcement
Class II
·Ongoing·Oxoid Australia Pty Limited·April 8, 2026
Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta). The heads connect via a 12/14 taper to the stem trunnion, and articulates against the crosslinked UHMWPE liner within the Logical Acetabular Cups. Product Usage: Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: ¿ Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis ¿ Inflammatory joint disease including rheumatoid arthritis ¿ Correction of functional deformity including congenital hip dysplasia ¿ Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture ¿ Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement
FDA Enforcement
Class II
·Terminated·Signature Orthopedics Pty Limited·March 14, 2018
SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading.
FDA Enforcement
Class II
·Terminated·Southern Implants, (Pty.) Ltd.·April 25, 2018