15 results
·
22ms
·
Sources: EU EUDAMED, US FDA
TSO3 OZONE STERILIZER, MODEL 125L
FDA 510(k)
FDA Class 2
·General Hospital
RTE SNAPCONE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FHW·July 11, 2023
FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES PROGRESSIVES (NELFILCON A) ONE-DAY SOFT CONTACT
FDA 510(k)
FDA Class 2
·Ophthalmic
STRYKER TRAUMA PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CADD
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·March 23, 2022
REAR TIP EXTENDER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code N/A·December 30, 2025
RTE SNAPCONE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FHW·February 17, 2021
CADD MEDICATION CASSETTE
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·July 14, 2022
CADD
FDA Adverse Event
Malfunction
·NULL·Product code FPA·August 17, 2021
CADD MEDICATION CASSETTES
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·June 6, 2022
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·May 2, 2013
DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SANTIAGO·Product code KPO·September 15, 2014
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 19, 2011
PROXIMATE*HCS HEMORR CIR STAPL (EXACT CODE UNKNOWN
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 30, 2019
STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
FDA Recall
Terminated
·Steris Corporation Hopkins Facility·Product code MED·December 7, 2011