16 results
·
25ms
·
Sources: EU EUDAMED, US FDA
CARETEX SURGEON'S HOODS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Cortina [MAX] Lumbar Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054
FDA 510(k)
FDA Unclassified
·Unknown
FREESTYLE FREEDOM
FDA Adverse Event
Injury
·Product code NBW·October 22, 2010
ATLAS PLUS HF CRT-D
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CRMD·Product code NIK·January 13, 2014
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·December 19, 2012
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·June 5, 2019
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·August 10, 2017
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·October 23, 2017
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·August 3, 2017
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·June 5, 2018
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·July 5, 2019
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·March 12, 2020
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·June 5, 2019
a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. Component. of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025
SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024