ClearanceBrief
Panels › General, Plastic Surgery › Product code FSY · Class 2

Light, Surgical, Ceiling Mounted

Regulation 878.4580

0510(k)s in 12 months (74 all time)
5recalls in 12 months (454 all time)
42recalls that name a 510(k)
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Top companies in FSY

Company510(k)sRecalls
Windstone Medical Packaging, Inc.0292
Resource Optimization & Innovation Llc077
Stryker Communications218
Covidien LLC014
Trumpf Medical Systems, Inc.111
Getinge Usa Sales Inc010
Berchtold Holding GmbH90
STERIS Corporation17
DKK Dai-Ichi Shomei Co., Ltd.06
GETINGE US SALES LLC06
DateFirm and productCodeLinked 510(k)
Nov 12, 2009MAQUET Inc.
XTEN LED DF cupola, P/N: 567815999. Intended to provide visible illumination for the surgical field or for the examination of the patient.
Terminated		 FSYK040735
Nov 12, 2009MAQUET Inc.
XTEN LED Video DF cupola, P/N: 567801999. Intended to provide visible illumination for the surgical field or for the examination of the patient.
Terminated		 FSYK040735
Nov 12, 2009MAQUET Inc.
XTEN DF cupola, P/N: 567800999. Intended to provide visible illumination for the surgical field or for the examination of the patient.
Terminated		 FSYK040735
Apr 1, 2009Trumpf Medical Systems, Inc.
ILED Surgical Light, Model numbers: ILED3, ILED5 and ILED5K
Terminated		 FSYK061317

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