ClearanceBrief
Company

Deroyal Surgical -Rose Hill

FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.

0510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
6recalls that name a 510(k)

Product codes

CodeDeviceRecords
KKXDrape, Surgical, Antimicrobial6
MNVStrip, Dialysate Ph Indicator1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Sep 29, 2004Deroyal Surgical -Rose Hill
Stockinette, Double Ply, Econo Weave, EZ Roll, 6 X 60'', 8 X 60'', Ref#9991-60, #9993-60
Terminated
KKXK030365
Sep 29, 2004Deroyal Surgical -Rose Hill
Stockinette, Double Ply, Econo Weave, 6 X 54'', 6 X 60'', 6 X 72'', 8 X 48'', 8 X 72'', Ref #9984-54, #9984-54, #9985-60, #9986-72, #9987-48, #9988-60, #9988-72
Terminated
KKXK030365
Sep 29, 2004Deroyal Surgical -Rose Hill
Stockinette, Double Ply, Standard Weave, 6 X 60'', 6 X 72'', 8 X 48'', 8 X 60'', 8 X 72'', 10 X 48''
Terminated
KKXK030365
Sep 29, 2004Deroyal Surgical -Rose Hill
Stockinette, Single Ply, Standard Weave, 8 X 72'' and 10 X 48'', Ref #9508-72, #9510-48, #9510-48, #9510-60
Terminated
KKXK030365
Sep 29, 2004Deroyal Surgical -Rose Hill
Stockinette, Single Ply Econo Weave, 8 X 72'', Ref #9999-72.
Terminated
KKXK030365
Sep 29, 2004Deroyal Surgical -Rose Hill
Impervious Stockinette, Large, 12'' X 48'' or 12'' X 54'', Ref #9806-54, #9816-54, and #9978-12; X-Large, 16'' X 48'', Ref #9978-16
Terminated
KKXK030365
Apr 3, 2003Deroyal Surgical -Rose Hill
DeRoyal''s SurgiMate (tm) Skin Stapler, Rotating Head, product #25-1001, packaged with 35 or more stainless steel staples in peel away pouch. Pouch is labeled in part, ***sterile, disposable, do not r
Terminated
MNVNone listed
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