5 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension, Model Number: FCA026-001, Manufactured by: Value Plastics dba Nordson MEDICAL, 805 West 71st Street, Loveland, CO 80538, packaged in Bags consisting of 100, 500 or 1,000 stopcocks.
FDA Enforcement
Class II
·Terminated·Value Plastics, Inc.·March 16, 2016
UROLOGY PACK- (10) GAUZE SPONGE 4" X 4" 16PLY (1) TUBE SUCTION CONNECT Y." X12' (1) SYRINGE 30cc WITHOUT NEEDLE ULOCK (1) BASIN RING (1) TUR Y SET, 2 LEAD, ST. (1) BAG SUTURE FLORAL (1) GOWN SURG. REINF. XL EXTRA LONG LEVEL IV (2) TOWEL CLAMP (1) DRAPE LITHOTOMY W/LEGGIN I POUCH UF 11 0" x 63" (2) SHEET DRAPE 41 " X 58" SMS (1) COVER TABLE REINF 50" X 90" (1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX (3) TOWELS ABSORBENT 15" X 20" (1) GOWN IMP. SMS EXTRA REINF. XL T/WRAP LEVEL IV (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) TIME OUT BEACON NON WOVEN ST. 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
Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·July 16, 2014
STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs. The STERRAD CYCLESURE 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·August 8, 2012
MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·August 10, 2016