ClearanceBrief
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

DateFirm and productCodeLinked 510(k)
Oct 7, 2015Resource 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
FSYNone listed
Oct 7, 2015Resource 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
FSYNone listed
Oct 7, 2015Resource 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
FSYNone listed
Oct 7, 2015Resource 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
FSYNone listed
Oct 7, 2015Resource 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
FSYNone listed
Oct 7, 2015Resource 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
FSYNone listed
Oct 7, 2015Resource 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
FSYNone listed
Oct 7, 2015Resource 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
FSYNone listed
Oct 7, 2015Resource 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
FSYNone listed
Aug 7, 2015Trumpf 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
FSYK061317
Aug 7, 2015Trumpf 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
FSYK061317
Aug 7, 2015Trumpf 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
FSYK011693
Aug 7, 2015Trumpf 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
FSYK061317
Aug 7, 2015Trumpf 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
FSYK061317
Jul 20, 2015Covidien LLC
Hysto Pack, Non-sterile Part Number Description SA2059B MAJOR BASIN SA2220 HYSTO PACK SA2220A HYSTO PACK
Terminated
FSYNone listed
Jul 20, 2015Covidien 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
FSYNone listed
Jul 20, 2015Covidien LLC
NS-3600-B LITE GLOVE 1000/CASE -Bulk, Non-sterile Catalog Number: 571711
Terminated
FSYNone listed
Jul 20, 2015Covidien LLC
Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation Kit
Terminated
FSYNone listed
Jul 20, 2015Covidien 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
FSYNone listed
Jul 20, 2015Covidien LLC
Major Kit, Sterile-.Kits containing the Devon Light Glove Catalog Number:Description 573831B MAJOR KIT
Terminated
FSYNone listed
Jul 20, 2015Covidien 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
FSYNone listed
Jul 20, 2015Covidien 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
FSYNone listed
Jul 20, 2015Covidien 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
FSYNone listed
Jul 20, 2015Covidien 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
FSYNone listed
Jul 20, 2015Covidien 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
FSYNone listed
Jul 20, 2015Covidien 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
FSYNone listed
Jul 20, 2015Covidien 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
FSYNone listed
Jul 20, 2015Covidien 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
FSYNone listed
Jul 7, 2015Maquet 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
FSYK040735
K070442 +1
Jun 15, 2015Beaver-Visitec International Inc.
BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584676 Ophthalmic surgical kits
Terminated
FSYNone listed
Jun 15, 2015Beaver-Visitec International Inc.
BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584671 Ophthalmic surgical kits
Terminated
FSYNone listed
Jun 15, 2015Beaver-Visitec International Inc.
BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584649 Ophthalmic surgical kits
Terminated
FSYNone listed
Jun 15, 2015Beaver-Visitec International Inc.
BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584648 Ophthalmic surgical kits
Terminated
FSYNone listed
Jun 15, 2015Beaver-Visitec International Inc.
BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584569 Ophthalmic surgical kits
Terminated
FSYNone listed
Apr 29, 2015Centurion 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
FSYNone listed
Apr 22, 2015Windstone Medical Packaging, Inc.
Port Access Kit, Kit number PSS1505(C convenience custom kits used for general surgery in hospital operating room
Terminated
FSYNone listed
Apr 22, 2015Windstone 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
FSYNone listed
Apr 22, 2015Windstone Medical Packaging, Inc.
Laparoscopy Kit, Kit number PSS1038(A and PSS1038(B convenience custom kits used for general surgery in hospital operating room
Terminated
FSYNone listed
Apr 22, 2015Windstone Medical Packaging, Inc.
Dr. Fritsch Pack, Kit number AMS2696 convenience custom kits used for general surgery in hospital operating room
Terminated
FSYNone listed
Apr 22, 2015Windstone Medical Packaging, Inc.
Virginia Custom Pack, Kit number RMS1744 convenience custom kits used for general surgery in hospital operating room
Terminated
FSYNone listed
Apr 22, 2015Windstone Medical Packaging, Inc.
Vein Kit - No Introducer TVS4027-NI(A convenience custom kits used for general surgery in hospital operating room
Terminated
FSYNone listed
Apr 22, 2015Windstone Medical Packaging, Inc.
Vaginal Pack, Kit number AMS1722 convenience custom kits used for general surgery in hospital operating room
Terminated
FSYNone listed
Apr 22, 2015Windstone Medical Packaging, Inc.
Upper Torso Tray, Kit number PSS1554(B convenience custom kits used for general surgery in hospital operating room
Terminated
FSYNone listed
Apr 22, 2015Windstone Medical Packaging, Inc.
Upper Extremity Pack, Kit number AMS2536 and AMS2536(A convenience custom kits used for general surgery in hospital operating room
Terminated
FSYNone listed
Apr 22, 2015Windstone Medical Packaging, Inc.
Universal Pack, Kit number AMS2036 convenience custom kits used for general surgery in hospital operating room
Terminated
FSYNone listed
Apr 22, 2015Windstone Medical Packaging, Inc.
Transvaginal Pack, Kit number CMP1767 convenience custom kits used for general surgery in hospital operating room
Terminated
FSYNone listed
Apr 22, 2015Windstone Medical Packaging, Inc.
Total Knee Pack, Kit number AMS4010(A convenience custom kits used for general surgery in hospital operating room
Terminated
FSYNone listed
Apr 22, 2015Windstone 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
FSYNone listed
Apr 22, 2015Windstone Medical Packaging, Inc.
Total Hip Pack, Kit number PSS2956 convenience custom kits used for general surgery in hospital operating room
Terminated
FSYNone listed
Apr 22, 2015Windstone Medical Packaging, Inc.
Taymour GYN Pack, Kit number PSS2642 convenience custom kits used for general surgery in hospital operating room
Terminated
FSYNone listed

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