8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
SUCTION RETRACTOR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ACCESSORY TO LASER EQUIPMENT - SMOKE EVACUATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARIN
FDA 510(k)
FDA Class 2
·Hematology
STYLE 120 SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·January 21, 2025
ESSURE
FDA Adverse Event
Injury
·BAYER·Product code HHS·June 16, 2014
VIRTUOSO VR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code LWS·October 19, 2010
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 17, 2012
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015