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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)
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Top companies in LRO

DateFirm and productCodeLinked 510(k)
Jul 7, 2015Stradis Healthcare, LLC.
General Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Vaginal Rejuvenation Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Lipo/Buttocks Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Lipo Pack, Liposuction Expended Pack, and Liposuction Tray - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Standard Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Phleb Pack and Laser Phleb Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Endovenous Kit, Endo Pack and Endovenous Laser Kit - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis 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
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Advanced Vein Care - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Basic Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Breast Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jun 25, 2015DeRoyal 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
LRONone listed
Jun 9, 2015Alcon 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
LROK880961
Jan 8, 2015Centurion Medical Products Corporation
Diagnostic Imaging Tray (General Surgery convenience kit)
Terminated
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, Inc
Breast Pack Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed
Dec 16, 2014Customed, 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
LRONone listed

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