12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS
FDA 510(k)
FDA Class 2
·Cardiovascular
VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7
FDA 510(k)
FDA Class 2
·Immunology
DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 28, 2025
BATTERY OSCILLATOR
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code MOQ·May 24, 2013
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·September 30, 2014
CAPSURE SP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011
ADULT INSPIRATORY HEATED BREATHING CIRCUITS
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·December 11, 2013
DELTA CER HEAD 12/14 36MM +12
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code LZO·February 27, 2025
VENTED AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·December 3, 2013
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009; c) 2110344-010; d) 2110344-011; e) 2110344-013; f) 2110344-019; g) 2110344-025; h) 2110344-029; i) 2110344-030; j) 2110344-032 ; Radiological image processing system
FDA Enforcement
Class II
·Ongoing·GE Healthcare·September 25, 2024