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. Surgical Pack, Kit number PSS3540 and PSS3540(A convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Student Pack-NS, Kit number PSS2788 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Spine Pack, Kit number AMS3753 and AMS3783(A convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638, AMS3711, AMS4212, PSS1852(A, convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and PSS2209(B. convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Set-Up Pack, Kit number PSS1305(B and PSS1305(C convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Set Up Pack, Kit number PSS3574(A convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Robotic Pack, Kit number AMS4389 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Podiatry Pack, Kit number AMS1541, AMS2778, PSS2645, and PSS3422 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Podiatry Kit PSS1040(A, PSS1040(B, and PSS1040(C convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Plastic Pack , Kit number AMS1833(A convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Plastic Kit, Kit number CMP1084(B convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Plastic General Pack, Kit number AMS4215 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Peri Kit, Kit number PSS1037 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Peri GYN, Kit number PSS2193(A convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Percutaneous Entry Kit, Kit number TVS4022(C and TVS4022(D convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Pelviscopy/Laparoscopy Pack, Kit number PSS3342 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Pacemaker Kit, Kit number AMS4281 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Ortho Pack, Kit number PSS3466 and PSS3466(A convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Ortho Minor Pack, Kit number AMS3710 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Ortho Kit, Kit number PSS1039(A and PSS1039(B convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Open Procedure Pack II, Kit number RMS1740(A convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Ocular Plastic Pack, Kit number AMS3868 and AMS3868(A convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. OB/GYN Pack, Kit number AMS2038 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Newport Coast Basic Pack, Kit number 007484-1 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Nasal Pack, Kit number PSS2186 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Morris Lap Pack, Kit number PSS3199 and PSS3199(A convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Morris Hysto Pack, Kit number PSS3198 and PSS3198(A convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Mok Eye Pack, Kit number PSS2640 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Minor/General/Ortho Pack, Kit number PSS3258, PSS3258(A, and PSS3258(B convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Minor Tray AMS2685 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Minor Pack AMS1374(A, CMP1560, PSS3517, PSS3517(A, PSS3518, PSS3518(A, PSS3541, and PSS3541(A. convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Minor Ortho Pack, Kit number 002646-12 and 002646-13 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Minor Lithotomy Pack, Kit number 002650-7 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Minor Lap Pack, Kit number AMS2624 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Minor Arthroscopy Pack, Kit number 002649-14 and 002649-15 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Mammoplasty Pack, Kit number AMS2535 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Major Pack, Kit Number PSS3516 and PSS3516(A convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Major Ortho Pack, kit number 002647-12 and 002647-13 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Major Lithotomy Pack, kit number 002641-5 and 002641-6 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Major Laparotomy Pack - NS, kit number AMS4347 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Major Kit, Kit number PHC1307(A convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Major General Pack, Kit number 002645-11 and 002645-12 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Major Breast Pack, Kit number AMS3409 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Lumbar Laminectomy Pack, Kit number AMS2501 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Lower Extremity Pack, Kit number AMS1375(A, AMS2540, AMS2540(A, and AMS4669. convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Local Pack, Kit number AMS1544 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Lithotomy Pack, Kit number AMS2333 and AMS2333(A convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Liposuction Pack, Kit number AMS3323 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed
Apr 22, 2015	Windstone Medical Packaging, Inc. Lipo Pack, Kit number AMS4420 convenience custom kits used for general surgery in hospital operating room Terminated	FSY	None listed

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