Panels › General, Plastic Surgery › Product code LRO · Class 2
General Surgery Tray
Regulation 878.4370
0510(k)s in 12 months (110 all time)
103recalls in 12 months (1,084 all time)
141recalls that name a 510(k)
Top companies in LRO
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 3, 2015 | Customed, Inc LAPAROTOMY PK 4/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
LRO | K902191 |
| Sep 3, 2015 | Customed, Inc WOUND MANAGEMENT CUSTOMED 20/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
LRO | K950295 |
| Sep 3, 2015 | Customed, Inc UMBILICAL VESSEL CATHETER KIT CUSTOMED 8/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
LRO | None listed |
| Sep 3, 2015 | Customed, Inc PLASTIC SURGERY PACK 5/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
LRO | K904693 |
| Sep 3, 2015 | Customed, Inc PEDIATRIC LAP PACK 8/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
LRO | K904693 |
| Sep 3, 2015 | Customed, Inc PREMIUM LAPAROTOMY PK CUSTOMED 6/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
LRO | None listed |
| Sep 3, 2015 | Customed, Inc WOUND MANAGEMENT TRAY II 30/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
LRO | None listed |
| Sep 3, 2015 | Customed, Inc WOUND MANAG.TRAY 24/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
LRO | None listed |
| Sep 3, 2015 | Customed, Inc MINOR PROCEDURE PACK 40/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
LRO | K902031 |
| Sep 3, 2015 | Customed, Inc MAJOR LAPAROTOMY PK 4/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
LRO | K902031 |
| Jul 7, 2015 | Stradis Healthcare, LLC. Upper Extremity Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Arthroscopy Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Orthopedic Split Drape Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. DND Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Custom Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Blepharoplasty Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Set Up Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Face Lift Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Pediatric Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Open Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Cysto Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Neurosurgery Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Minor Pack and Minor Pack II Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Podiatry Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Hand Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. ENT Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Knee Arthro Pack and Knee Arthro Pack II - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Shoulder Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Glaucoma Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Eye Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Head & Neck Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Gyn Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Stradi 4500 - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Abdominal Pack and Abdom Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Face Neck Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Bariatric Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Vasc Custom Kit - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Skin and Vein Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Lima Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Hand Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. ACL Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Suction Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Plastic Pack and Plastic HNP Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Face Lift Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Mississippi Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Surgical Pack and General Surgery Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Tummy Tuck Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Breast Augmentation Pack and Breast Augmentation Expanded Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Laser Evlt Pack and Laser One Leg Evlt - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Vein & Vascular Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
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