144 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
REGARD Newborn Tray
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 24, 2021
REGARD Vitrectomy Tray
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 24, 2021
REGARD Stereotactic Tray
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 24, 2021
REGARD Ear Tray
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 24, 2021
REGARD Ultrasound Tray
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 24, 2021
REGARD Basic Cataract tray
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 24, 2021
REGARD Core Biopsy Tray
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 24, 2021
Isolation Droplet Bundle Kit
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·July 8, 2020
Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.
FDA Recall
Terminated
·ROi CPS LLC·Product code MLS·October 12, 2020
Respirator Crash Cart Kit
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·July 8, 2020
Isolation Droplet Bundle Kit
FDA Recall
Terminated
·ROi CPS LLC·Product code OEA·May 19, 2020
Respirator Crash Cart Kit
FDA Recall
Terminated
·ROi CPS LLC·Product code OEV·May 19, 2020
Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number 830015012 b) regard GS00310C - Max Barrier Central Line Trpl Lumen 16cm, Sulfa-coated catheter, Item Number: 830027 c) regard GS00309B - Max Barrier Central Line Dual Lumen 16cm, Sulfa-coated catheter, Item Number: 830026 d) regard GS00307B - Max Barrier Central Line Trpl Lumen 20cm, Sulfa-coated catheter, Item Number: 830024 e) regard AN00211K - PICC PACK - WASHINGTON, Item Number, 880189011 f) regard GS00311B - Max Barrier Central Line Quad Lumen 20cm, Sulfa-coated catheter, Item Number: 830028 g) regard LD00866B-VAG DELIVERY MOTHER - LEBANON, Item Number 830084 h) regard LD00199NL-C SECTION MOTHER - JOPLIN, Item Number 830014 i) regard GS0348D - CVC TRIPLE LUMEN 20CM NON SULFA - , Item Number 830034 Product Usage: These custom procedural trays contain surgical instruments and accessories intended for use during a surgical procedure.
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·February 5, 2020
REGARD Vitrectomy Tray
FDA Recall
Terminated
·ROi CPS LLC·Product code OJK·August 10, 2021
REGARD Core Biopsy Tray
FDA Recall
Terminated
·ROi CPS LLC·Product code LRO·August 10, 2021
REGARD Ear Tray
FDA Recall
Terminated
·ROi CPS LLC·Product code OGR·August 10, 2021
REGARD Basic Cataract tray
FDA Recall
Terminated
·ROi CPS LLC·Product code OJK·August 10, 2021
REGARD Stereotactic Tray
FDA Recall
Terminated
·ROi CPS LLC·Product code OIP·August 10, 2021
REGARD Newborn Tray
FDA Recall
Terminated
·ROi CPS LLC·Product code MLS·August 10, 2021
REGARD Ultrasound Tray
FDA Recall
Terminated
·ROi CPS LLC·Product code OIP·August 10, 2021