15 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
Silicone Round Drain
FDA UDI
C. R. Bard, Inc.·00801741049439·Silicone Round Drain, Medium 1/8" (10 Fr., 3.2m...
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108694055·Step Drill Stop for L11.5mm Implant, Wide Long
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108697674·Titanium Base Abutment Round, Int. Hex. SP L4mm...
CONTROL MODULE ALGORITHM ENHANCEMENT FOR THE MODEL S500-ST AND MODEL S400
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 25, 2025
VENTRALEX
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·July 11, 2017
VENTRALIGHT ST
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·July 11, 2017
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Other
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·April 16, 2013
COBAS PHENYTOIN
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code DIP·April 27, 2011
AFFINITY 4
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code HDD·June 30, 2008
NEOPUFF INFANT RESUSCITATOR
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTL·August 5, 2012
RELIAVAC CLOSED WOUND SUCTION EVACUATOR
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON) -1018233·Product code GCY·August 16, 2019
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020