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: 800036003, Sterile, LD0274C - C Section Pack - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure t
Terminated
FSYNone listed
Oct 7, 2015Resource Optimization & Innovation Llc
regard Item Number: 800036002, Sterile, LD0274B - C Section Pack - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure t
Terminated
FSYNone listed
Oct 7, 2015Resource Optimization & Innovation Llc
regard Item Number: 880331, Sterile, OR0762 - Total Knee - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray con
Terminated
FSYNone listed
Oct 7, 2015Resource Optimization & Innovation Llc
regard Item Number: 880330, Sterile, OR0761 - Total Hip - 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: 880328, Sterile, HT0759 - Pacemaker 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: 880327, Sterile, CV0758 - 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 tr
Terminated
FSYNone listed
Oct 7, 2015Resource Optimization & Innovation Llc
regard Item Number: 880326, Sterile, GS0757 - Major Basin - 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: 880323, Sterile, LD0754 - 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 con
Terminated
FSYNone listed
Oct 7, 2015Resource Optimization & Innovation Llc
regard Item Number: 880321, Sterile, GS0752 - Breast Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, St. Louis, MO. Custom procedure tray contain
Terminated
FSYNone listed
Oct 7, 2015Resource Optimization & Innovation Llc
regard Item Number: 800623, Sterile, NU0787 - Neuro - surgical kit containing light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgi
Terminated
FSYNone listed
Oct 7, 2015Resource Optimization & Innovation Llc
regard Item Number: 800617, Sterile, NU0768 - 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: 800615, Sterile, CV0741 - Peripheral Vascular - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure
Terminated
FSYNone listed
Oct 7, 2015Resource Optimization & Innovation Llc
regard Item Number: 800599, Sterile, GS0694 - Robotic Lap - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray co
Terminated
FSYNone listed
Oct 7, 2015Resource Optimization & Innovation Llc
regard Item Number: 800597, Sterile, GY0688 - LAVH - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains
Terminated
FSYNone listed
Oct 7, 2015Resource Optimization & Innovation Llc
regard Item Number: 800569, Sterile, CV0659 - 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 tr
Terminated
FSYNone listed
Oct 7, 2015Resource Optimization & Innovation Llc
regard Item Number: 800568, Sterile, OR0658 - Titanium Rib - 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: 800567, Sterile, GY0656 - Robotic Hysterectomy - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedur
Terminated
FSYNone listed
Oct 7, 2015Resource Optimization & Innovation Llc
regard Item Number: 800566, Sterile, NU0655 - VP Shunt - 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: 800565, Sterile, CV0654 - Pediatric Heart - 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: 800562, Sterile, NU0651 - Neuro - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains
Terminated
FSYNone listed
Oct 7, 2015Resource Optimization & Innovation Llc
regard Item Number: 800560, Sterile, GS0649 - 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 cont
Terminated
FSYNone listed
Oct 7, 2015Resource Optimization & Innovation Llc
regard Item Number: 800559, Sterile, ET0648 - Head & Neck - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray co
Terminated
FSYNone listed
Oct 7, 2015Resource Optimization & Innovation Llc
regard Item Number: 800558, Sterile, OR0647 - Extremity - 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: 800557, Sterile, LD0646 - 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
Oct 7, 2015Resource Optimization & Innovation Llc
regard Item Number: 800555, Sterile, HT0644 - Pediatric Card Cath - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure
Terminated
FSYNone listed
Oct 7, 2015Resource Optimization & Innovation Llc
regard Item Number: 800554, Sterile, GS0643 - Pediatric Basic - 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: 800553, Sterile, OR0642 - Total Knee - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray con
Terminated
FSYNone listed
Oct 7, 2015Resource Optimization & Innovation Llc
regard Item Number: 800551, Sterile, GS0640 - 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 cont
Terminated
FSYNone listed
Oct 7, 2015Resource Optimization & Innovation Llc
regard Item Number: 800550, Sterile, OR0639 - Hip Shoulder - 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: 800549, Sterile, ET0638 - Head & Neck - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray co
Terminated
FSYNone listed
Oct 7, 2015Resource Optimization & Innovation Llc
regard Item Number: 800548, Sterile, OR0637 - Extremity - 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: 800546, Sterile, GS0635 - Abdominal - 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: 800535, Sterile, LD0620 - 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
Oct 7, 2015Resource Optimization & Innovation Llc
regard Item Number: 800533, Sterile, GS0606 - Abdominal Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO Custom procedure tray co
Terminated
FSYNone listed
Oct 7, 2015Resource Optimization & Innovation Llc
regard Item Number: 800532, Sterile, GY0616 - Vaginal Hysterectomy - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO Custom procedure
Terminated
FSYNone listed
Oct 7, 2015Resource Optimization & Innovation Llc
regard Item Number: 800531, Sterile, NU0615 - 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: 800528, Sterile, GS0612 - 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: 800527, Sterile, OR0611 - Hip Shoulder 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: 800526, Sterile, ET0610 - Head and Neck - 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: 800525, Sterile, OR0609 - Extremity Pack - 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: 800524, Sterile, LD0608 - 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 con
Terminated
FSYNone listed
Oct 7, 2015Resource Optimization & Innovation Llc
regard Item Number: 800514, Sterile, LD0592 - C Section Pack - 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: 800508, Sterile, LD0586 - 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 con
Terminated
FSYNone listed
Oct 7, 2015Resource Optimization & Innovation Llc
regard Item Number: 800425, Sterile, CV0494 - AV Access Pk -Spohn surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure t
Terminated
FSYNone listed
Oct 7, 2015Resource Optimization & Innovation Llc
regard Item Number: 800422, Sterile, OR0491 - Arthroscopy 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: 800419, Sterile, GY0488 - D&C 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: 800418, Sterile, GY0487 - Major Vaginal 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
FSYNone listed
Oct 7, 2015Resource Optimization & Innovation Llc
regard Item Number: 800417, Sterile, GY0486 - Laparoscopy 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: 800416, Sterile, GY0485 - Robotic Hysterectomy Pkg - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom pro
Terminated
FSYNone listed
Oct 7, 2015Resource Optimization & Innovation Llc
regard Item Number: 800415, Sterile, OR0484 - Shoulder System Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure
Terminated
FSYNone listed

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