12 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
Smith & Nephew, Inc.·03596010038890·FEMORAL CEMENT COMPRESSOR
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213032545·microSelectron Coupling Transfer Tube (14)
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 8, 2025
G7 AUTOMATED HPLC ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
AUDIT MICROCV PROCALCITONIN LINEARITY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GYNECARE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTO·May 2, 2018
TRAUMA STRETCHER
FDA Adverse Event
Malfunction
·HILLROM DE MEXICO S DE RL DE CV·Product code FPO·May 3, 2013
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDI·September 23, 2014
DELTA CER HEAD 12/14 36MM +1.5
FDA Adverse Event
Injury
·DEPUY IRELAND ¿ REG. # 9616671·Product code LZO·May 13, 2011
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025