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) |
|---|---|---|---|
| Oct 7, 2015 | Resource Optimization & Innovation Llc regard Item Number: 800414, Sterile, OR0483 - Total Joint 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: 800413, Sterile, CV0482 - Vascular 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: 800411, Sterile, NU0480 - 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 conta Terminated |
FSY | None listed |
| Oct 7, 2015 | Resource Optimization & Innovation Llc regard Item Number: 800410, Sterile, CV0479 - 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 tray Terminated |
FSY | None listed |
| Oct 7, 2015 | Resource Optimization & Innovation Llc regard Item Number: 800409, Sterile, GS0478 - 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 tray Terminated |
FSY | None listed |
| Oct 7, 2015 | Resource Optimization & Innovation Llc regard Item Number: 800408, Sterile, LD0477 - 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 tray c Terminated |
FSY | None listed |
| Oct 7, 2015 | Resource Optimization & Innovation Llc regard Item Number: 800407, Sterile, OR0476 - 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 cont Terminated |
FSY | None listed |
| Oct 7, 2015 | Resource Optimization & Innovation Llc regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Custom procedure tray contai Terminated |
FSY | None listed |
| Oct 7, 2015 | Resource Optimization & Innovation Llc regard Item Number: 800091, Sterile, LD0692 - 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 cont Terminated |
FSY | None listed |
| Aug 7, 2015 | Trumpf Medical Systems, Inc. Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia HD, User Manual #1513140.
The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's bod Terminated |
FSY | K061317 |
| Aug 7, 2015 | Trumpf Medical Systems, Inc. Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia SD, User Manual #1400191.
The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's bod Terminated |
FSY | K061317 |
| Aug 7, 2015 | Trumpf Medical Systems, Inc. Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual #1441784.
The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patie Terminated |
FSY | K011693 |
| Aug 7, 2015 | Trumpf Medical Systems, Inc. Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Manual #1528403.
The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patien Terminated |
FSY | K061317 |
| Aug 7, 2015 | Trumpf Medical Systems, Inc. Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932.
The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body w Terminated |
FSY | K061317 |
| Jul 20, 2015 | Covidien LLC Hysto Pack, Non-sterile
Part Number Description
SA2059B MAJOR BASIN
SA2220 HYSTO PACK
SA2220A HYSTO PACK Terminated |
FSY | None listed |
| Jul 20, 2015 | Covidien LLC Non Sterile Subassembly:
Catalog Number/Description:
SA1008 NONSTERILE SUBASSEMBLY
SA1578 NO-STERILE SUBASSEMBLY
SA2000 NON STERILE SUBASSEMBLY
SA2001 NON STERILE SUBASSEMBLY
SA2002 NON STERILE SUBAS Terminated |
FSY | None listed |
| Jul 20, 2015 | Covidien LLC NS-3600-B LITE GLOVE 1000/CASE -Bulk, Non-sterile
Catalog Number: 571711 Terminated |
FSY | None listed |
| Jul 20, 2015 | Covidien LLC Augmentation Kit , Sterile-.Kits containing the Devon Light Glove
Catalog Number/Description
573732 7620-CWA Augmentation Kit Terminated |
FSY | None listed |
| Jul 20, 2015 | Covidien LLC Single Basin Kits, Sterile-.Kits containing the Devon Light Glove
Catalog Number/Description:
573509 7696-GSL-VL SINGLE BASIN KIT
573558 7665-CPB SINGLE BASIN KIT
573561 7696-KSC SINGLE BASIN KIT
311 Terminated |
FSY | None listed |
| Jul 20, 2015 | Covidien LLC Major Kit, Sterile-.Kits containing the Devon Light Glove
Catalog Number:Description
573831B MAJOR KIT Terminated |
FSY | None listed |
| Jul 20, 2015 | Covidien LLC Double Basin Kit ,Sterile-Kits containing the Devon Light Glove
Catalog Numbers/Description:
31145504 7708 Double Basin Kit
50007898 7898-T8 Double Basin Kit
50007899 7899-T8 Double Basin Kit Terminated |
FSY | None listed |
| Jul 20, 2015 | Covidien LLC Surgical Kit Sterile-Kits containing the Devon Light Glove
Catalog Numbers/Description:
573326 7497-HLS Surgical Kit
573328 7437-NRF SURGICAL ASC KIT
573343 7499-88 SURGICAL KIT with Light Gloves
5733 Terminated |
FSY | None listed |
| Jul 20, 2015 | Covidien LLC ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove
Catalog Numbers/Decription:
573328 7437-NRF SURGICAL ASC KIT
50000511 7516-UNI Universal ASC Kit
50000512 7557-UNI Universal ASC Kit
50 Terminated |
FSY | None listed |
| Jul 20, 2015 | Covidien LLC Surgical Set Up kit, Sterile-Kits containing the Devon Light Glove
Catalog Numbers/Description:
31144895 7614-T4 Single Basin Set Up Kit
31144960 7693-T4 Single Basin Set Up Kit
31144978 7766 Double B Terminated |
FSY | None listed |
| Jul 20, 2015 | Covidien LLC Minor Surgical Kits, Sterile-Kits containing the Devon Light Glove
Catalog Numbers/Description:
573208 7519-DHCG MINOR KIT
573210 7581-CSD Minor KIT
573741 7667-HMI Minor Kit
31144507 7519 Minor Surgi Terminated |
FSY | None listed |
| Jul 20, 2015 | Covidien LLC Mini-Kits, Sterile-Kits containing the Devon Light Glove
Catalog Numbers/Description
31141479 K-1842-S OR Mini Kit
31141487 K-1560-S3 OR Mini Kit
31141495 K-1530-S3 OR Mini Kit
31141537 K-1940-S OR M Terminated |
FSY | None listed |
| Jul 20, 2015 | Covidien LLC Delivery/C-Section, Sterile-Kits containing the Devon Light Glove
Catalog Numbers/Description:
56479 7335-SMC C-Section Kit
31404851 7382-OTO2 Delivery Kit
52000076E 7339-ES C-SECTION DELUXE P Terminated |
FSY | None listed |
| Jul 20, 2015 | Covidien LLC Covidien Devon Light Gloves, Sterile-Single Units
A disposable, sterile, single-use cover for compatible surgical light handles.
Catalog/Number/Description
31140208 3611 LIGHT GLOVE
31140216 3613 L Terminated |
FSY | None listed |
| Jul 7, 2015 | Maquet Cardiovascular Us Sales, Llc The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling surgical light systems Terminated |
FSY | K040735 K070442 +1 |
| Jun 15, 2015 | Beaver-Visitec International Inc. BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove
Part Number: 584676
Ophthalmic surgical kits Terminated |
FSY | None listed |
| Jun 15, 2015 | Beaver-Visitec International Inc. BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove
Part Number: 584671
Ophthalmic surgical kits Terminated |
FSY | None listed |
| Jun 15, 2015 | Beaver-Visitec International Inc. BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove
Part Number: 584649
Ophthalmic surgical kits Terminated |
FSY | None listed |
| Jun 15, 2015 | Beaver-Visitec International Inc. BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove
Part Number: 584648
Ophthalmic surgical kits Terminated |
FSY | None listed |
| Jun 15, 2015 | Beaver-Visitec International Inc. BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove
Part Number: 584569
Ophthalmic surgical kits Terminated |
FSY | None listed |
| Apr 29, 2015 | Centurion Medical Products Corporation Convenience Kits from Centurion that
contain a Medtronic/Covidien Light Glove
ED SUTURE KIT
VAGINAL DELIVERY TRAY
ENDOSCOPY TRAY
MINOR BASIN SET
LAPAROSCOPIC BASIN TRAY Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Port Access Kit, Kit number PSS1505(C
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Mohs Closer Pack, kit number PSS1827(A, PSS1827(B, and PSS1827(C
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Laparoscopy Kit, Kit number PSS1038(A and PSS1038(B
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Dr. Fritsch Pack, Kit number AMS2696
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Virginia Custom Pack, Kit number RMS1744
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Vein Kit - No Introducer TVS4027-NI(A
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Vaginal Pack, Kit number AMS1722
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Upper Torso Tray, Kit number PSS1554(B
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Upper Extremity Pack, Kit number AMS2536 and AMS2536(A
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Universal Pack, Kit number AMS2036
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Transvaginal Pack, Kit number CMP1767
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Total Knee Pack, Kit number AMS4010(A
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Total Joint Pack, Kit number 006358-5 and 006358-6
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Total Hip Pack, Kit number PSS2956
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
| Apr 22, 2015 | Windstone Medical Packaging, Inc. Taymour GYN Pack, Kit number PSS2642
convenience custom kits used for general surgery in hospital operating room Terminated |
FSY | None listed |
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