13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BG MORSELS
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814565·GENUMEDI SAND SIZE V
Gyrus ACMI
FDA UDI
Gyrus ACMI, LLC·00821925041684·MODEL 2420 Somnoplasty (5/Pk)
MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KIMGUARD ONE-STEP STERILIZATION WRAP
FDA 510(k)
FDA Class 2
·General Hospital
TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC
FDA Adverse Event
Injury
·COOK INC·Product code LJS·December 3, 2015
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 29, 2025
GALAXY INTRAVASCULAR ULTRASOUND SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code IYO·May 29, 2013
ALLEGRETTO WAVE
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·September 29, 2014
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·June 17, 2011
INSTINCT ENDOSCOPIC HEMOCLIP
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code PKL·July 19, 2021
INSTINCT ENDOSCOPIC HEMOCLIP
FDA Adverse Event
Injury
·WILSON-COOK MEDICAL INC·Product code PKL·September 12, 2022
Depuy SIGMA RP TC3 insert; polyethylene tibial insert, Sz 5, 12.5 mm; Ref 96-2362.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005