35 results
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17ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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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
SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
FDA Enforcement
Class I
·Ongoing·Glycar SA Pty., Ltd.·December 3, 2025
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