6 results
·
7ms
·
Sources: EU EUDAMED, US FDA
Laparoscopy Pack, Catalog number 900-028. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class I
·Terminated·Customed, Inc·December 10, 2014
98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
FDA Enforcement
Class I
·Terminated·ICU Medical, Inc.·October 1, 2014
Customed Laparoscopy convenience pack include multiple components: gowns, table covers, needle and blade counter, bag suture, suture, sponges/gauzes, containers, syringes 20cc & 30cc w/o needle, needle, drape, tubing, towel, dressing island, and blade surgical SS. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
HIP PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (2) GOWN XL SMS IMPERV. REINFORCED (1) MAYO STAND COVER REINFORCED (1) SUTURE BAG (1) DRAPE UTILITY WITH TAPE (1) STOCKINETTE IMPERV. 14" X 48" (1) U-DRAPE 54 X 72 WITH TAPE SPLIT HIP DRAPE 89" X 128" WITH POUCH TABLE COVER REINFORCED 50" X 90" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
HIP PACK I (2), CUSTOMED, code 900-2504 (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP (1) MAYO STAND COVER REINFORCED (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) STOCKINETTE IMPERVIOUS 12" X 48" (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) DRAPE HIP 89" X 128" REINFORCED WITH ADHESIVE (1) COVER TABLE REINFORCED 50" X 90" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of imminent death from biventricular failure. Freedom Drivers are intended for use in and out of the hospital.
FDA Enforcement
Class I
·Terminated·SynCardia Systems Inc.·September 23, 2015