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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 31 Results
510(K) Number: K842648
 
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Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit. 2 08/26/2016 DeRoyal Industries Inc
DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O, 2 08/26/2016 DeRoyal Industries Inc
DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN. 3 02/23/2017 DeRoyal Industries Inc
DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) Incision and ... 2 12/06/2017 DeRoyal Industries Inc
DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Contai... 2 01/12/2018 DeRoyal Industries Inc
Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, ST... 2 02/16/2018 DeRoyal Industries Inc
DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack 2 07/16/2019 DeRoyal Industries Inc
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Ophthalmolo... 2 02/19/2020 Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Thyroid... 2 02/19/2020 Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Laparos... 2 02/19/2020 Deroyal Industries, Inc. Lafollette
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