13 results
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13ms
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Sources: EU EUDAMED, US FDA
Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·January 22, 2014
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01531S, for use on the cranium
FDA Enforcement
Class II
·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018
AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01541S, for use on the cranium
FDA Enforcement
Class II
·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018
TopCare Clifford THE BIG RED DOG power toothbrush for kids!
FDA Enforcement
Class II
·Terminated·Ranir Corporation·January 29, 2014
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).
FDA Enforcement
Class II
·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018
AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium
FDA Enforcement
Class II
·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, for use on the cranium
FDA Enforcement
Class II
·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
FDA Enforcement
Class II
·Terminated·QiG Group LLC·March 30, 2016
Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
FDA Enforcement
Class II
·Terminated·QiG Group LLC·March 30, 2016
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)
FDA Enforcement
Class II
·Terminated·QiG Group LLC·March 30, 2016
Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated cartons. Product Usage: The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP)
FDA Enforcement
Class II
·Terminated·Blackrock Microsystems, LLC·September 14, 2016
Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747. Product Usage: The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP)
FDA Enforcement
Class II
·Terminated·Blackrock Microsystems, LLC·September 14, 2016
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).
FDA Enforcement
Class II
·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018