82 results · 7ms · Sources: EU EUDAMED, US FDA

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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

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

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

ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product Code: 345SVVO1

FDA Enforcement
Class II ·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020

Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve,Auxiliary Water Jet Connector Diversatek Healthcare 102 E.Keefe Ave. Milwaukee,WI 53212 USA Product Code: 1203-72

FDA Enforcement
Class II ·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020

STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229

FDA Enforcement
Class II ·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020

STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10232

FDA Enforcement
Class II ·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020

Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GAR3846

FDA Enforcement
Class II ·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020

Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004

FDA Enforcement
Class II ·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020

Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biopsy Valve Manufactured for: Diversatek Healthcare 102 E.Keefe Ave. Milwaukee, WI 53212 USA Product Code: 1203-71

FDA Enforcement
Class II ·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020

STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy-valve/auxiliary water connector) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.1

FDA Enforcement
Class II ·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020

ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Water Connector Product Code: 345SVVO4

FDA Enforcement
Class II ·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020

STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.2

FDA Enforcement
Class II ·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020