62 results
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7ms
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Sources: EU EUDAMED, US FDA
microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.
FDA Enforcement
Class I
·Ongoing·FHC, Inc.·November 20, 2024
TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use. Packed on lead per outer white shelf box.
FDA Enforcement
Class I
·Terminated·Oscor, Inc.·November 14, 2018
Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
FDA Enforcement
Class I
·Ongoing·SD Biosensor, Inc.·May 31, 2023
STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.
FDA Enforcement
Class I
·Ongoing·SD Biosensor, Inc.·March 23, 2022
Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·February 25, 2026
Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·February 25, 2026
Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·February 25, 2026
Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare.
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·December 3, 2025
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025