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) |
|---|---|---|---|
| Apr 14, 2016 | Customed, Inc Catalog Number: 9001408
UMBILICAL VESSEL CATHETER KIT
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 |
| Apr 14, 2016 | Customed, Inc Catalog Number: 9001402
PLASTIC SURGERY PACK
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | K950295 |
| Apr 14, 2016 | Customed, Inc Catalog Number: 9001296
PREMIUM LAPAROTOMY PACK
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | K902029 |
| Apr 14, 2016 | Customed, Inc Catalog Number: 9001198 WOUND MANAGE II
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | K950295 |
| Apr 14, 2016 | Customed, Inc Catalog Number: 9001154 WOUND MANAGEMENT TRAY
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | K950295 |
| Apr 14, 2016 | Customed, Inc Catalog Number: 9001091 PERY-GYN SURGICAL PACK
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 |
| Apr 14, 2016 | Customed, Inc Catalog Number: 9001061 PERI-GYN SURGICAL PACK
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 |
| Apr 14, 2016 | Customed, Inc Catalog Number: 900052 MINOR PROCEDURE SURGICAL PACK
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | K902031 |
| Apr 14, 2016 | Customed, Inc Catalog Number: 900036 LAPAROTOMY SURGICAL PACK
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | K902031 |
| Apr 14, 2016 | Customed, Inc Catalog Number: 900032 UNIVERSAL DRAINAGE TRAY
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | K901442 |
| Apr 14, 2016 | Customed, Inc Catalog Number: 900028 LAPAROSCOPY SURGICAL PACK Terminated |
LRO | None listed |
| Jan 28, 2016 | Gi Supply Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and snap-in holders for most components. Packed sterile in Tyvek bag.
Catalog #: GIS-28
Lot #: 61442434
Expiratio Terminated |
LRO | K970187 |
| Dec 2, 2015 | DeRoyal Industries Inc DeRoyal sterile custom surgical kits:
1) Emergency CABG Pack Pgybk, ref 89-7859.01
2) Emergency CABG Pack Pgybk, ref 89-7859.02
3) Open Heart Pack A&B Pgybk, ref 89-7750.02
4) Open Heart Pack A&B Pgyb Terminated |
LRO | None listed |
| Nov 6, 2015 | DeRoyal Industries Inc DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE or 2016-09EF, or 2016-09EG, or Catalog No. 863, Lot No. 2016-08D Terminated |
LRO | None listed |
| Nov 6, 2015 | DeRoyal Industries Inc DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE:
TOTAL KNEE A & B, REF 89-4561.11; TOTAL HIP A & B, REF 89-4562.12; PODIATRY Terminated |
LRO | None listed |
| Nov 5, 2015 | Resource Optimization & Innovation Llc Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use during a surgical procedure. Terminated |
LRO | None listed |
| Oct 30, 2015 | Alcon Research, Ltd. Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure. Terminated |
LRO | K880961 |
| Sep 21, 2015 | Resource Optimization & Innovation Llc Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG A&B. Used in cardiovascular surgical procedures. Terminated |
LRO | None listed |
| Sep 21, 2015 | Resource Optimization & Innovation Llc Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures. Terminated |
LRO | None listed |
| Sep 3, 2015 | Customed, Inc LAPAROTOMY PACK 3/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate 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 Terminated |
LRO | None listed |
| Sep 3, 2015 | Customed, Inc LAPAROTOMY PACK CS/6
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 GENERAL MINOR PK 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 | K904694 |
| Sep 3, 2015 | Customed, Inc INCISION AND DRAINAGE TRAY 50/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 LAPAROTOMY BASIC PACK 10/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
LRO | K902029 |
| Sep 3, 2015 | Customed, Inc MINOR LAPAROTOMY PK 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 | K902030 |
| Sep 3, 2015 | Customed, Inc MAJOR LAP PACK 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 |
| Sep 3, 2015 | Customed, Inc ANGIODRAPE PACK DAMAS 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 | K904694 |
| Sep 3, 2015 | Customed, Inc BREAST PACK-TPSC 3/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 GOWN IMPERVIOUS EXTRA LONG 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 | K971920 |
| Sep 3, 2015 | Customed, Inc FACE PACK FJG 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 TUMMY TUCK PACK-FJG 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 FACE LIFT 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 | None listed |
| Sep 3, 2015 | Customed, Inc BREAST PACK-BOD 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 HAIR RESTORATION PACK-THR 12/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 CYSTO TUR PACK BASIC 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 | K902274 |
| Sep 3, 2015 | Customed, Inc BASIC 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 | None listed |
| Sep 3, 2015 | Customed, Inc LAPAROTOMY SURGICAL PACK 3/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 TUMMY TUCK & BREAST PACK-RFMHI 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 FACE PACK MRT 8/CS CUSTOMED
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 LAPAROTOMY PACK 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 | None listed |
| Sep 3, 2015 | Customed, Inc MINOR PACK 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 | None listed |
| Sep 3, 2015 | Customed, Inc UROLOGY SURGICAL PACK 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 LUMBAR PACK 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 | None listed |
| Sep 3, 2015 | Customed, Inc SURGICAL PACK 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 | K902886 |
| Sep 3, 2015 | Customed, Inc LITHOTOMY PACK 10/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 HIGADO Y PANCREA 2/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 LAPAROTOMY PACK CUSTOMED 7/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 MINOR LACERATION TRAY CUSTOMED 50/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 MINOR LAP. PACK 5/CS REV.
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
LRO | K902886 |
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