6 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Vision Care, Inc.·April 4, 2018
Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
FDA Enforcement
Class II
·Ongoing·Lacrimedics Inc·March 9, 2022
CardioTek EP-TRACER Software V2.x.
FDA Enforcement
Class II
·Completed·CardioTek BV·June 29, 2022
Sterile Custom Packs to be used in surgical procedures.
FDA Enforcement
Class II
·Terminated·American Contract Systems·June 10, 2020
DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)00190446673552 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
FDA Enforcement
Class II
·Terminated·DJ Orthopedics de Mexico S.A. de C.V.·May 5, 2021
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015