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

Company	510(k)s	Recalls
Windstone Medical Packaging, Inc.	0	292
Resource Optimization & Innovation Llc	0	77
Stryker Communications	2	18
Covidien LLC	0	14
Trumpf Medical Systems, Inc.	1	11
Getinge Usa Sales Inc	0	10
Berchtold Holding GmbH	9	0
STERIS Corporation	1	7
DKK Dai-Ichi Shomei Co., Ltd.	0	6
GETINGE US SALES LLC	0	6

Date	Firm and product	Code	Linked 510(k)
Apr 22, 2015	Windstone Medical Packaging, Inc. Laparotomy Tray, Kit number PSS1538 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Laparotomy Pack, Kit number 006047-2, 006268-8, 006268-9, AMS4418, PSS2154, PSS2190, and PSS2190(A. convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Laparotomy Kit, Kit number PSS1036(A and PSS1036(B convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Laparoscopy Pack, Kit number AMS2537 and AMS2537(A convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Laparoscopic Pack, Kit number AMS2499 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Lap/Pelviscopy Pack, Kit number AMS4151, PSS3256, PSS3256(A convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Lap/Hyst Pack, Kit number AMS2539 and AMS2539(A convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Lap Gallbladder Pack, Kit number AMS3707 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Lap Band Pack, Kit number AMS1785(A convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Laminectomy Pack, Kit number AMS2763, AMS2763(A, PSS1844, PSS1844(B convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Knee Scope Pack, Kit number AMS2498 and AMS2498(A convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Knee Pack, Kit number AMS4211 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Knee Arthroscopy Pack AMS2610, AMS2610(A, AMS3236, PSS2188(A, and PSS2208(A convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Hystero Pack, Kit number PSS3535 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. HSG Pack, Kit number PSS3287 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Hernia Pack, Kit number AMS1519 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Head Pack, Item number PSS1934(B convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Head and Neck Pack, kit numbers AMS1373(A, AMS1869, AMS2534, and AMS2534(A. convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Hand Tray PSS2365(A, PSS2365(B, PSS2365(C, PSS2365(D PSS2365(E, convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A, PSS2153(B, PSS2187(B, PSS2351, and PSS3073. convenience custom kits used for general surge Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Hall SAP, Kit number SRK1031(A convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. GYN-Laparoscopy Tray AMS1196(A convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. GYN Pack, Kit number PSS2643 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. GYN Lap Pack, Kit number PSS2194(B convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. GLBSC Minor Pack, Kit number PSS2644 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. General Surgery Pack, Kit number PSS1380(A convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. General Plastics Pack, Kit number 008617-1 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. General Plastic Pack, Kit number PSS2432, PSS2432(A, PSS2717, PSS2717(A, and PSS2717(B. convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. General Pack II, Kit number CMP1812(B convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. General Pack I, Kit number CMP1811(B convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. General Pack, Kit numbers: AMS2334, AMS2334(A, AMS2967, AMS2967(A, AMS3239, AMS3709, and AMS3709(A. convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. General Male Pack, Kit number AMS1580 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Foot Pack, Kit number AMS3637 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Facial Tray, Kit number PSS1558(A convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Facial Plastic Pack, Kit numbers AMS2533, AMS2533(A, and AMS3327 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Face Pack, Kit number AMS3641 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Eye Tray, Kit number PSS1834 and PSS1939 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Eye Plastic Tray, Kit number PSS1931(A convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Extremity Tray, Kit number AMS1200(B and AMS1200(C convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Extremity Pack-N Brunswick, kit number PSS1866(A convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A PSS1381(B, PSS1798(A, PSS1842(A, and PSS2706 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. ENT Tray, Kit number AMS1195(A convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. ENT Pack, Kit number AMS2727, AMS3237(A, and AMS4214. convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Endoscopy Pack, Kit number PSS1646 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Dr. Newman Surgical Procedure Pack, kit numbers PSS1689 PSS1689(A convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Dr. Landi EVLT Pack, Kit numbers AMS1483(A, AMS1483(B, and AMS1483(C convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Dr. Harrimans Kit, Kit number PSS3600 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Dr. Fetters Hand Pack, Kit number AMS3690 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Dr. Casey Pack, kit number AMS4313 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Dr Mullins Kit, kit number PSS1861(A convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed

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