48 results
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7ms
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Sources: EU EUDAMED, US FDA
Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·July 26, 2023
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40
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
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
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
Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilators.
FDA Enforcement
Class I
·Ongoing·GE Healthcare, LLC·June 15, 2022
Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)
FDA Enforcement
Class I
·Ongoing·GE Healthcare, LLC·June 15, 2022
TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023
TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023
TruSignal Ear Sensor, REF TS-E-D; Oximeter
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023
TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023
TruSignal Wrap Sensor, REF TS-W-D; Oximeter
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023
TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms)
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023
TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023
TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023
TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023
GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: 6600-0047-851, 6600-0033-850, 6600-0081-850, 6600-0961-500, 6600-0083-850
FDA Enforcement
Class I
·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024
GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M1166814
FDA Enforcement
Class I
·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024