23 results
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30ms
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Sources: EU EUDAMED, US FDA
BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT
FDA 510(k)
FDA Class 2
·Ophthalmic
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040011355·Zirlux 16+ 0M1 95X12
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033378830·
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033378816·
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033378823·
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033378847·
INSET II
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 2, 2026
INSET II
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 2, 2026
INSET II
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 2, 2026
INSET II
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 2, 2026
INSET II
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 2, 2026
FLEXI-SITE SP02 EAR SENSOR
FDA 510(k)
FDA Class 2
·Cardiovascular
MILLENNIA ACUPUNCTURE NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 17, 2025
INSYTE AUTOG BC BLU 22GA X 1.0IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·July 15, 2021
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·March 19, 2013
FOUNDATION HIP
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWL·March 1, 2011
ACCU-CHEK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 10, 2008
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 31, 2025
Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor with two Blood Parameter modules and one HSat Probe; 500AVHCT Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37¿C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·August 22, 2018