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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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510(K)
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dual port wizard low profile replacement gastrostomy device; dual port wizard feeding/decompression tube, model 00220w C.R. Bard, Inc. k013144 10/19/2001
bard eska jonas silicone-silver penile prosthesis C.R. Bard, Inc. k864040 10/24/1986
bard (r) lubricious - coated ureteral stent suture C.R. Bard, Inc. k903345 04/30/1991
siemens-elma pulse generator #718 Burditt & Calkins-Siemens-Elema k830344 05/27/1983
ultra r-11 cruiser Brookefield Hunter, Inc. k915609 02/11/1992
brightway brand latex examination glove-(powder free, sterile) containing 50 ugm or less of water extractable protein pe Brightway Holdings Sdn. Bhd. k032940 11/20/2003
brainlab elements image fusion, contouring (4.5);image fusion (4.5);fibertracking (2.0);bold mri mapping (1.0);image fusion angio (1.0) Brainlab AG k223106 07/14/2023
spyscope ds access and delivery catheter, spyscope ds ii access and delivery catheter, spyglass ds digital controller Boston Scientific Corporation k183636 01/22/2019
wallflex colonic soft stent system with anchor lock delivery system, wallflex duodenal soft stent system with anchor lock delivery system Boston Scientific Corporation k200257 04/17/2020
healy/montgomery stent system (hms system(tm)) Boston Medical Products, Inc. k912290 08/26/1991

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