167 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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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
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.
FDA Enforcement
Class II
·Ongoing·Augustine Temperature Management, LLC·December 25, 2024
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
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia
FDA Enforcement
Class II
·Ongoing·Augustine Temperature Management, LLC·February 26, 2025
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia
FDA Enforcement
Class II
·Ongoing·Augustine Temperature Management, LLC·February 26, 2025
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermia
FDA Enforcement
Class II
·Ongoing·Augustine Temperature Management, LLC·February 26, 2025
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.
FDA Enforcement
Class II
·Completed·Augustine Temperature Management, LLC·January 22, 2025
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
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.
FDA Enforcement
Class II
·Ongoing·Augustine Temperature Management, LLC·December 25, 2024
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
Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Model Number: 230000 ¿ If the recalled product is a software, include version number: firmware versions 5.0.5 or earlier
FDA Enforcement
Class II
·Ongoing·Breas Medical, Inc.·July 20, 2022
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; 3) WC77V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.
FDA Enforcement
Class II
·Completed·Augustine Temperature Management, LLC·January 22, 2025
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC71V; 2) WC71V-DEMO; 3) WC71V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.
FDA Enforcement
Class II
·Completed·Augustine Temperature Management, LLC·January 22, 2025
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.
FDA Enforcement
Class II
·Completed·Augustine Temperature Management, LLC·January 22, 2025