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)
Top companies in FSY
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 11, 2017 | Windstone Medical Packaging, Inc. Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A
Product packaged in a convenient manner for use in a general clinical procedure Terminated |
FSY | None listed |
| Apr 11, 2017 | Windstone Medical Packaging, Inc. Dicken Eye Pack, part number CPA-3202-2.
Product packaged in a convenient manner for use in a general clinical procedure Terminated |
FSY | None listed |
| Apr 11, 2017 | Windstone Medical Packaging, Inc. Custom Tray, part numbers PSS1111 and PSS1111(A.
Product packaged in a convenient manner for use in a general clinical procedure Terminated |
FSY | None listed |
| Apr 11, 2017 | Windstone Medical Packaging, Inc. Cataract Pack, part numbers 008886-1, AMS2806, PSS3442, PSS3442(A, WAL1155, and WAL1155(A.
Product packaged in a convenient manner for use in a general clinical procedure Terminated |
FSY | None listed |
| Apr 11, 2017 | Windstone Medical Packaging, Inc. Cataract Kit - Dr. Slingsby, part number CMP1017(B.
Product packaged in a convenient manner for use in a general clinical procedure Terminated |
FSY | None listed |
| Apr 11, 2017 | Windstone Medical Packaging, Inc. Cataract Kit, part numbers CAT1467AM and CAT1538(B.
Product packaged in a convenient manner for use in a general clinical procedure Terminated |
FSY | None listed |
| Mar 10, 2017 | Stryker Communications The Stryker Visum LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light. Affected part numbers are 0682001432 (EDS LIGHT SUSPEN Terminated |
FSY | K060802 |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Vein Tray, part number AMS6312 Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Vascular Pack, part number AMS4030
Vascular Pack, part number AMS4030(A Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Upper Torso Tray, part number PSS1554(B Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Upper Extremity Pack, part number AMS4670
Upper Extremity Pack, part number AMS4670(A Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Universal Pack, part number AMS2036 Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Transvaginal Pack, part number CMP1767 Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Total Knee Pack (15710), part number AMS6563 Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Total Joint Pack, part number 006358-6 Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Total Hip Pack, part number PSS2956 Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Surgical Pack, part number PSS3540(A Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Stem Pack, part number AMS5166 Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Spine Pack , part number AMS3753(A
Spine Pack, part number AMS3783(A
Spine Pack, part number AMS3783(B
Spine Pack, part number AMS6472 Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Shoulder Pack, part number AMS2936
Shoulder Pack, part number AMS3638
Shoulder Pack, part number AMS3711(B
Shoulder Pack, part numbere AMS4212
Shoulder Pack, part number AMS6460
Shoulder Pack, part nu Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Shoulder Arthroscopy Pack, part number AMS2496(A
Shoulder Arthroscopy Pack, part number AMS2496(B
Shoulder Arthroscopy Pack, part number AMS2496(C
Shoulder Arthroscopy Pack, part number AMS2609
Should Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Set-Up Pack, part number PSS1305(C Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Set Up Pack, part number PSS3574(A Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Robotic Pack, part number AMS4389 Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Reduction Mammoplasty Pack, part number AMS4380
Reduction Mammoplasty Pack, part number AMS4380(B Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Podiatry Pack, part number AMS2778
Podiatry Pack, part number AMS2778(A
Podiatry Pack, part number AMS3785(B
Podiatry Pack, part number AMS3785(C
Podiatry Pack, part number AMS4011(A
Podiatry Pack, pa Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Plastic Surgery Pack, part number AMS5685 Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Plastic Pack, part number PSS2462
Plastic Pack, part number PSS3319
Plastic Pack, part number PSS3319(A Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Plastic Kit, part number CMP1084(C Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Plastic General Pack, part number AMS4215 Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Peri GYN, part number PSS2193(A Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Percutaneous Entry Kit, part number TVS4022(D
Percutaneous Entry Kit , part number TVS4022(E
Percutaneous Entry Kit, part number TVS4022(F Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Pacemaker Kit, part number AMS4281
Pacemaker Kit, part number AMS4281(A
Pacemaker Kit, part number AMS4281(C
Pacemaker Kit, part number AMS4281(D Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Ortho Pack, part number PSS3466(A Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Ortho Minor Pack, part number AMS3710(A Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Orbitofacial Pack, part number AMS5850(A Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Opgrande Hand Pack, part number AMS4767 Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Open Procedure Pack II, part number RMS1740(A Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Open Procedure Pack, part number AMS4596
Open Procedure Pack, part number AMS4596(A
Open Procedure Pack, part number AMS4596(B Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Ocular Plastic Pack, part number AMS3868(A Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Newport Coast Basic Pack, part number 007484-1 Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Nasal Pack, part number PSS2186 Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Morris Lap Pack, part number PSS3199(A Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Morris Hysto Pack, part number PSS3198(A Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Minor/General/Ortho Pack, part number PSS3258(B Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Minor Tray, part number AMS2685 Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Minor Procedure Pack, part number AMS4799 Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Minor Pack, part number AMS3782(B
Minor Pack, part number AMS3782(C
Minor Pack, part number CMP1560
Minor Pack, part number PSS3518(B
Minor Pack, part number PSS3541(A Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Major Pack (1345), part number AMS6565 Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Major Laparotomy Pack - NS, part number AMS4347 Terminated |
FSY | None listed |
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