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U.S. Department of Health and Human Services

Medical Device Recalls

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21 to 30 of 33 Results
510(K) Number: K842648
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Product Description
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DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl al... 2 04/06/2022 DeRoyal Industries Inc
DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and iso... 2 04/06/2022 DeRoyal Industries Inc
DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06 1 06/10/2021 DeRoyal Industries Inc
Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Cus... 2 02/19/2021 DeRoyal Industries Inc
CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-... 2 02/19/2021 DeRoyal Industries Inc
Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom sur... 2 02/19/2021 DeRoyal Industries Inc
DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack 2 07/16/2019 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 Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Contai... 2 01/12/2018 DeRoyal Industries Inc
DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) Incision and ... 2 12/06/2017 DeRoyal Industries Inc
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