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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 8 of 8 Results
ProductCode: NEW Applicant: ETHICON, INC. Decision Date To: 04/23/2024
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pds plus antibacterial (polydioxanone) sterile synthetic absorable surgical suture Ethicon, Inc. K212380 02/22/2022
stratafix spiral pds plus bidirectional knotless tissue control device Ethicon, Inc. K192144 03/25/2020
vicryl polyglactin 910 sterile synthetic absorbable surgical suture, pds ii polydioxanone sterile synthetic absorbable surgical suture, pds plus antibacterial polydioxanone sterile synthetic absorbable surgical suture Ethicon, Inc. K183183 06/27/2019
stratafix symmetric pds plus knotless tissue control devices, stratafix spiral pds plus knotless tissue control devices, stratafix spiral monocryl plus knotless tissue control devices, stratafix spiral monocryl knotless tissue control devices Ethicon, Inc. K182873 01/10/2019
stratafix spiral pds plus knotless tissue control device ETHICON, INC. K150670 07/02/2015
stratafix symmetric pds plus knotless tissue control devices ETHICON, INC. K141776 10/15/2014
pds(tm) barbed sutures ETHICON, INC. K113004 12/20/2011
pds plus antibacterial suture ETHICON, INC. K061037 07/14/2006
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