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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)
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 880321001, Sterile, GS0752A - Breast Pk - OSU
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800415001, Sterile, OR0484A - Shoulder System Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800566002, Sterile, NU0655B - VP Shunt - Childrens Santa Rosa
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800414003, Sterile, OR0483C - Total Joint Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800407003, Sterile, OR0476C - Ortho Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800623002, Sterile, NU0787B - Neuro - Medical Center Santa Rosa
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800560003, Sterile, GS0649C - Lap Chole - Childrens Santa Rosa
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800535001, Sterile, LD0620A - C Section - New Braunfels
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800599003, Sterile, GS0694C - Robotic Lap - Christus Highland
Terminated
LRONone listed
Sep 29, 2016Covidien LLC
Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove Item Number Description 380789003 SURE SET SIN
Terminated
LRONone listed
Sep 29, 2016Covidien LLC
Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
Terminated
LRONone listed
Sep 29, 2016Covidien LLC
Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
Terminated
LRONone listed
Aug 26, 2016DeRoyal Industries Inc
DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O,
Terminated
LROK842648
Aug 26, 2016DeRoyal Industries Inc
Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit.
Terminated
LROK842648
Aug 18, 2016Avid Medical, Inc.
MAMMOGRAPHY
Terminated
LRONone listed
Aug 18, 2016Avid Medical, Inc.
PEDIATRIC KIDNEY BIOPSY TRAY
Terminated
LRONone listed
Aug 18, 2016Avid Medical, Inc.
Convenience Kits, MOHS "OPENING" PROCEDURE TRAY
Terminated
LRONone listed
Aug 18, 2016Avid Medical, Inc.
Convenience Kits, MOHS "OPENING" PROCEDURE TRAY
Terminated
LRONone listed
Apr 14, 2016Customed, Inc
Catalog Number: 900996 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
LROK902029
Apr 14, 2016Customed, Inc
Catalog Number: 900946 STRABISMUS SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
LRONone listed
Apr 14, 2016Customed, Inc
Catalog Number: 900782 SKIN STAPLE REMOVER STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
LRONone listed
Apr 14, 2016Customed, Inc
Catalog Number: 900774 INCISION AND DRAINAGE TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
LRONone listed
Apr 14, 2016Customed, Inc
Catalog Number: 900618A LAPAROSCOPY-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
LRONone listed
Apr 14, 2016Customed, Inc
Catalog Number: 900576A LAP-CHOLECYSTECTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, e
Terminated
LRONone listed
Apr 14, 2016Customed, Inc
Catalog Number: 900547 BASIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
LROK902029
Apr 14, 2016Customed, Inc
Catalog Number: 900540 WOUND MANAGEMENT TRAY III Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
LRONone listed
Apr 14, 2016Customed, Inc
Catalog Number: 900474 LAPAROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
LRONone listed
Apr 14, 2016Customed, Inc
Catalog Number: 900450 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
LROK902030
Apr 14, 2016Customed, Inc
Catalog Number: 900345 BASIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
LROK902886
Apr 14, 2016Customed, Inc
Catalog Number: 9003190 SURG GOWN SMS AMMI IV FULL Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
LROK971920
Apr 14, 2016Customed, Inc
Catalog Number: 9002899 CYSTO TUR SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
LROK902274
Apr 14, 2016Customed, Inc
Catalog Number: 9002829 BASIC SURG PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
LRONone listed
Apr 14, 2016Customed, Inc
Catalog Number: 900281A LAPAROTOMY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
LRONone listed
Apr 14, 2016Customed, Inc
Catalog Number: 9002516 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
LROK902031
Apr 14, 2016Customed, Inc
Catalog Number: 9002511 MINOR SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
LRONone listed
Apr 14, 2016Customed, Inc
Catalog Number: 9002510 UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
LRONone listed
Apr 14, 2016Customed, Inc
Catalog Number: 9002469 BASIC SURGICAL PACK IV Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
LRONone listed
Apr 14, 2016Customed, Inc
Catalog Number: 9002259A LAPAROSCOPY-COLORECTAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds
Terminated
LRONone listed
Apr 14, 2016Customed, Inc
Catalog Number: 9002224 SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
LROK902886
Apr 14, 2016Customed, Inc
Catalog Number: 9002167 LITHOTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
LRONone listed
Apr 14, 2016Customed, Inc
Catalog Number: 9001966 LIVER & PANCREAS SURGERY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
LRONone listed
Apr 14, 2016Customed, Inc
Catalog Number: 9001765 MINOR LACERATION TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
LROK950295
Apr 14, 2016Customed, Inc
Catalog Number: 900176 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
LROK902031
Apr 14, 2016Customed, Inc
Catalog Number: 9001738 UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
LROK962652
Apr 14, 2016Customed, Inc
Catalog Number: 900169 UNIVERSAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
LRONone listed
Apr 14, 2016Customed, Inc
Catalog Number: 900168 LABOR & DELIVERY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
LROK902273
Apr 14, 2016Customed, Inc
Catalog Number: 900164 FEMORAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
LROK904694
Apr 14, 2016Customed, Inc
Catalog Number: 9001521 UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
LROK962652
Apr 14, 2016Customed, Inc
Catalog Number: 9001496 D&C LAPAROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
LRONone listed
Apr 14, 2016Customed, Inc
Catalog Number: 9001460 REYITO PLUS UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, e
Terminated
LROK962652

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