8 results · 8ms · Sources: EU EUDAMED, US FDA

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BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.

FDA Enforcement
Class II ·Terminated·Toshiba American Medical Systems Inc·April 3, 2013

BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

Alinity m System, Part No. 08N53-002

FDA Enforcement
Class II ·Terminated·Abbott Molecular, Inc.·January 12, 2022

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.

FDA Enforcement
Class II ·Terminated·Advanced Sterilization Products·April 10, 2013

Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

FDA Enforcement
Class II ·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020