285 results
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15ms
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Sources: EU EUDAMED, US FDA
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Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ; 2) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH1; 3) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH2; 4) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH3; 5) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH4; 6) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMH5; 7) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMH6; 8) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMHA; 9) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMHB; 10) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMHC; 11) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMHD; 12) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMHE; 13) ENT PACK , Catalog Number: SEN55ENSH2; 14) ENT PACK , Catalog Number: SEN55ENSHA; 15) ENT PACK , Catalog Number: SEN55ENSHB; 16) EYE PACK , Catalog Number: SEY51EYKIK; 17) PLASTIC EYE PACK , Catalog Number: SEYOCPEHH1; 18) PLASTIC EYE PACK , Catalog Number: SEYOCPEHH2; 19) PLASTIC EYE PACK , Catalog Number: SEYOCPEHHB; 20) PLASTIC EYE PACK , Catalog Number: SEYOCPEHHC;;
FDA Enforcement
Class II
·Ongoing·Cardinal Health 200, LLC·January 22, 2025
Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·October 30, 2024
CLEAR EYES CONTCT LENS DRPS LBRCTNG .5FO, SKU 900531
FDA Enforcement
Class II
·Ongoing·Family Dollar Stores, Llc.·August 24, 2022
Eye Pack - contains Devon Light Glove Used during surgery
FDA Enforcement
Class II
·Completed·Stradis Healthcare, LLC.·July 15, 2015
Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. Merge Eye Care PACS is a software solution using databases for patient demographics, server and other systems of intercommunication with hospital systems via HL7 and DICOM to provide to clinicians a single image viewing and management solution of images imported from various contributing devices throughout the clinical environment. Merge Eye Care PACS provides the ability to review data from any network-connected computer, and is protected by appropriate security login which permits only authorized user access. Symphony uses 256 bit or greater encryption via secure socket layer (SSL) to assure a network environment which is secure.
FDA Enforcement
Class II
·Terminated·Merge Healthcare, Inc.·July 26, 2017
Medline convenience kits: BASIC EYE DYNJ905154I TUBAL LIGATION CDS CDS760053K
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·June 24, 2026
regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 30, 2022
regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kit
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 30, 2022
Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLC
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·March 26, 2025
Halyard EYE PLASTIC TRAY - Medical convenience kits Model Number: SAMM054-19
FDA Enforcement
Class II
·Ongoing·AVID Medical, Inc.·November 20, 2024
STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431
FDA Enforcement
Class II
·Ongoing·Stradis Medical, LLC dba Stradis Healthcare·December 21, 2022
regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kit
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 30, 2022
regard VITRECTOMY PK, EY00938C, Item Number 800733003; EYE surgery convenience kit
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 30, 2022
regard VITRECTOMY PACK, EY00266H, Item Number 800028008; eye surgery convenience kit
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 30, 2022
PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
FDA Enforcement
Class II
·Terminated·Topcon Medical Laser Systems, Inc·July 31, 2013
BAUSCH + LOMB EYE PACK, REF LYN003EYSPA. Convenience kit used in surgical procedures.
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·November 9, 2022
BAUSCH + LOMB EYE MUSCLE, REF VAL036EMESB. Convenience kit used in surgical procedures.
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·November 9, 2022
MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F.
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·November 26, 2025
Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·June 3, 2026
Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010
FDA Enforcement
Class I
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·March 6, 2024