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) |
|---|---|---|---|
| Jul 7, 2015 | Stradis Healthcare, LLC. General Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Vaginal Rejuvenation Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Lipo/Buttocks Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Lipo Pack, Liposuction Expended Pack, and Liposuction Tray - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Standard Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Phleb Pack and Laser Phleb Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Endovenous Kit, Endo Pack and Endovenous Laser Kit - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Vein Pack, Vein Treatment II Pack, Vein Brunswick Pack, Vein No Lidocaine Pack, Vein Ablation Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Advanced Vein Care - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Basic Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Breast Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jun 25, 2015 | DeRoyal Industries Inc Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves:
ANGIO TRAY, REF 50-12127; NEURO SPINE TRAY, LAP CHOLE TRACECART(R), REF 53-1931; MINOR PROCEDURE TRACECART (R), REF 53-1932; Terminated |
LRO | None listed |
| Jun 9, 2015 | Alcon Research, Ltd. The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for specific ophthalmic surgical procedures. Some Paks c Terminated |
LRO | K880961 |
| Jan 8, 2015 | Centurion Medical Products Corporation Diagnostic Imaging Tray (General Surgery convenience kit) Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Laparotomy Pack, Catalog # 900-996
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Strabismus And Plastic Pack, Catalog # 900-946
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Plastic Surgery Pack, Catalog # 900-920
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Urology Pack, Catalog # 900-868
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Laparotomy Pack, Catalog # 900-848
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc General Minor Pack, Catalog # 900-787
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Laparotomy Basic Pack, Catalog number 900-547
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Minor Laparotomy Pack, Catalog number 900-450.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Cysto Tur Pack, Catalog number 900-430
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Breat Pack-TPSC, Catalog number 900-3431.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Face Lift, Catalog number 900-3083.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Breast Pack
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Liposuction Pack, Catalog #900-3028
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Tummy Tuck Pack, Catalog #900-3026
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Hair Restoration Pack, Catalog #900-2966
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Cysto Tur Pack, catalog #900-2899
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Laparotomy Pack, catalog #900-2829
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Laparotomy Surgical Pack, catalog #900-281A
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Bandeja para Debridacion (Debridement Tray), Catalog #900-2702
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Tummy Tuck & Liposuction Pack, catalog #900-2661
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Liposuction Pack, catalog #900-2656
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Laparotomy Pack, catalog #900-2516
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Minor Pack, catalog #900-2511
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Urology Pack, catalog #900-2510
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Laparotomy Pack III (4), catalog #900-2492
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Transverse Laparotomy Pack (8), catalog #900-2491
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Laparotomy Pack 1 (2 & 3), catalog #900-2490
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Basic Pack 1 (III), catalog #900-2471
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Extremity Arm Pack, catalog #900-2438
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Vaginal Procedure Pack, catalog #900-2385
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc General Line Full Body Drape, catalog #900-2262
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Surgical Pack, catalog #900-2224
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Lithotomy Pack, catalog #900-2167
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Higado & Pancrea Pack, Catalog number 900-1966.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Endovenous Custom Pack, Catalog number 900-1937.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Universal Pack, Catalog number 900-1936.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
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