22 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PLUS CANCELLOUS BONE SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040011362·Zirlux 16+ 0M2 95X12
Surestream
FDA UDI
ORIDION MEDICAL 1987 LTD.·10884521552272·SURESTREAM
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033315781·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033315774·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033315767·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033315699·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033315750·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033315811·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033315798·
INSET
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 22, 2025
CUP: MPACT ACETABULAR SHELL Ø52 MULTI-HOLE
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·April 26, 2023
Q-LUX PLASMA 100 LIGHT CURE UNIT
FDA 510(k)
FDA Class 2
·Dental
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, PURPLE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
CM ALVIM IMPLANT 4.3X10
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·May 9, 2018
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·March 19, 2013
LIMA HIP
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code JDI·March 1, 2011
ACCU-CHEK COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 10, 2008
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
CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 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