46 results
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6ms
·
Sources: EU EUDAMED, US FDA
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
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
BRONCHOVIDEOSCOPE OLYMPUS BF-H1100
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025