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) |
|---|---|---|---|
| Feb 28, 2017 | Windstone Medical Packaging, Inc. D & C Pack, part number AMS4796(A Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. D & C Kit, part number CMP1466(A Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Custom Venous Kit, part number TVS4024(C Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Custom Pack - with Introducer Kit, part number TVS4011NI(L Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Custom Pack, part number AMS4776
Custom Pack, part number AMS4776(A
Custom Pack, part number AMS5643
Custom Pack, part number AMS5643(A
Custom Pack, part number AMS6012
Custom Pack, part number AMS638 Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Custom Breast Augmentation Pack, part number PSS2455(D Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. C-Tray Pack, part number PSS2707(A Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Chest Breast Drape, part number AMS5853 Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Catheter Pack, part number AMS4399(A Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Brow Pack, part number PSS1785(C Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Breast Recon Pack, part number AMS5698
Breast Recon Pack, part number AMS5698(A Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Breast Pack, part number AMS3238(A
Breast Pack, part number AMS4419(A
Breast Pack, part number AMS4419(B
Breast Pack, part number AMS5750
Breast Pack, part number AMS5750(A
Breast Pack, part number AM Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Breast Augmentation Pack, part number AMS1786(A
Breast Augmentation Pack, part number AMS2790(A
Breast Augmentation Pack, part number AMS3324(B
Breast Augmentation Pack, part number AMS4382
Breast Aug Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Bleph Pack, part number AMS3325(B Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Bayview Breast Pack, part number 009080-2 Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Bayview Abdominoplasty Pack, part number 009079-1 Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Basin Pack, part number AMS2497 Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Basic Tray, part number PSS1559(A Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Basic Setup Tray, part number AMS6414 Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Basic Setup Pack, part number AMS1787(A
Basic Setup Pack, part number AMS6519 Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Basic Pack (1185), part number AMS6560 Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Basic Pack, part number AMS1868(B
Basic Pack, part number AMS2608(A
Basic Pack, part number AMS3861
Basic Pack, part number AMS4309
Basic Pack, part number PSS1833
Basic Pack, part number PSS1833(A
Ba Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Basic Kit, part number CMP1109(A Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Basic Face Kit, part number PS517A(D Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Basic Extended Pack, part number AMS4421(A
Basic Extended Pack, part number AMS4421(B Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Augmentation Pack, part number AMS6370 Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Arthroscopy Pack, part number AMS6559 Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Arthroscopy Pack, part number AMS2938
Arthroscopy Pack, part number AMS3639
Arthroscopy Pack, part number AMS4765
Arthroscopy Pack, part number PSS1799
Arthroscopy Pack, part number PSS1845(A Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Anterior Cervical Fusion Pack, part number AMS2502(A
Anterior Cervical Fusion Pack, part number AMS2502(C Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Angio Pack, part number AMS6711 Terminated |
FSY | None listed |
| Feb 28, 2017 | Windstone Medical Packaging, Inc. Abdominoplasty Pack, Part numbers AMS3326(B, AMS4381, and AMS4381(B. Terminated |
FSY | None listed |
| Nov 2, 2015 | Trumpf Medical Systems, Inc. Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5 Completed |
FSY | K061317 K102758 |
| Oct 7, 2015 | Resource Optimization & Innovation Llc regard Item Number: 880327002, sterile, CV0758B - Open Heart A&B - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Custom procedure Terminated |
FSY | None listed |
| Oct 7, 2015 | Resource Optimization & Innovation Llc regard Item Number: 800569001, Sterile, CV0659A - Open Heart A&B - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Custom procedure Terminated |
FSY | None listed |
| Oct 7, 2015 | Resource Optimization & Innovation Llc regard Item Number 800568001, Sterile, OR0658A - Titanium Rib - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Custom procedure tra Terminated |
FSY | None listed |
| Oct 7, 2015 | Resource Optimization & Innovation Llc regard Item Number 800567001, Sterile, GY0656A - Robotic Hysterectomy - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Custom proc Terminated |
FSY | None listed |
| Oct 7, 2015 | Resource Optimization & Innovation Llc regard Item Number 800565001, Sterile, CV0654A - Pediatric Heart - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Custom procedure Terminated |
FSY | None listed |
| Oct 7, 2015 | Resource Optimization & Innovation Llc regard Item Number: 800560001, Sterile, GS0649A - Lap Chole - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Custom procedure tray c Terminated |
FSY | None listed |
| Oct 7, 2015 | Resource Optimization & Innovation Llc regard Item Number: 800554002, Sterile, GS0643B - Pediatric Basic - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Custom procedure Terminated |
FSY | None listed |
| Oct 7, 2015 | Resource Optimization & Innovation Llc regard Item Number: 800554001, Sterile, GS0643A - Pediatric Basic - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Custom procedure Terminated |
FSY | None listed |
| Oct 7, 2015 | Resource Optimization & Innovation Llc regard Item Number: 800528001, Sterile, GS0612A - Lap Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Custom procedure tra Terminated |
FSY | None listed |
| Oct 7, 2015 | Resource Optimization & Innovation Llc regard Item Number: 800524001, Sterile, LD0608A - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Custom procedure tray c Terminated |
FSY | None listed |
| Oct 7, 2015 | Resource Optimization & Innovation Llc regard Item Number: 800422001, Sterile, OR0491A - Arthroscopy Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Custom procedure t Terminated |
FSY | None listed |
| Oct 7, 2015 | Resource Optimization & Innovation Llc regard Item Number: 800413001, Sterile, CV0482A - Vascular Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Custom procedure tra Terminated |
FSY | None listed |
| Oct 7, 2015 | Resource Optimization & Innovation Llc regard Item Number: 800411002, Sterile, NU0480B - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Custom procedure tray c Terminated |
FSY | None listed |
| Oct 7, 2015 | Resource Optimization & Innovation Llc regard Item Number: 800411001, Sterile, NU0480A - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Custom procedure tray c Terminated |
FSY | None listed |
| Oct 7, 2015 | Resource Optimization & Innovation Llc regard Item Number: 800410001, Sterile, CV0479A - Open Heart Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Custom procedure t Terminated |
FSY | None listed |
| Oct 7, 2015 | Resource Optimization & Innovation Llc regard Item Number: 800408001, Sterile, LD0477A - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Custom procedure tr Terminated |
FSY | None listed |
| Oct 7, 2015 | Resource Optimization & Innovation Llc regard Item Number: 800407001, Sterile, OR0476A - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Custom procedure tray c Terminated |
FSY | None listed |
| Oct 7, 2015 | Resource Optimization & Innovation Llc regard Item Number: 800091001, Sterile, LD0692A - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Custom procedure tray c Terminated |
FSY | None listed |
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