BEUDAMED
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    regard Item Number: 800535, Sterile, LD0620 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·October 14, 2015

    regard Item Number: 800535, Sterile, LD0620 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Recall
    Terminated ·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015

    AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 (800) 535-5585 www.AMERIWATER.com. The AmeriWater MRO Portable Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to pre-treat and purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The AmeriWater Portable MROS model is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The AmeriWater Portable MRO1 model is for treatment of up to two patients in a hospital, clinic, or dialysis centers.

    FDA Enforcement
    Class II ·Terminated·AmeriWater Inc·September 12, 2012

    AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 (800) 535-5585 www.AMERIWATER.com. The AmeriWater MRO Portable Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to pre-treat and purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The AmeriWater Portable MROS model is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The AmeriWater Portable MRO1 model is for treatment of up to two patients in a hospital, clinic, or dialysis centers.

    FDA Recall
    Terminated ·AmeriWater Inc·Product code FIP·August 9, 2012

    ADVANTAGE Turbo 2-Button Shaver. Rx Only, Made In USA, NON STERILE. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.

    FDA Recall
    Terminated ·Linvatec Corp. dba ConMed Linvatec·Product code GEY·October 29, 2009

    REF 8788, 8mm C-REAMER, CANNULATED, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Intended for use in Arthroscopic knee procedures.

    FDA Recall
    Terminated ·Linvatec Corp. dba ConMed Linvatec·Product code LXH·January 28, 2010

    CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-023, STERILE, Rx Only Product Usage: The HeatWave Electrode is intended to be used for electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow and knee arthroscopic procedures.

    FDA Recall
    Terminated ·ConMed Corporation·Product code JOS·August 29, 2016

    REF 8570 MENISCAL REPAIR NEEDLE, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Intended for use in meniscal repairs.

    FDA Recall
    Terminated ·Linvatec Corp. dba ConMed Linvatec·Product code HWQ·January 28, 2010

    REF 70-0078-103, 3mm ARTHRO-KNIFE SHEATHED KNIFE, SERRATED, STRAIGHT, 2-SIDED, ROUND, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.

    FDA Recall
    Terminated ·Linvatec Corp. dba ConMed Linvatec·Product code HRX·January 28, 2010

    REF C4000 INTEQ TFCC SMALL JOINT SUTURING SYSTEM KITS, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.

    FDA Recall
    Terminated ·Linvatec Corp. dba ConMed Linvatec·Product code HRX·January 28, 2010

    REF 9903, DIGIT TRAP FINGER GRASPING DEVICE, LARGE STERILE. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Intended for use in small joint arthroscopic procedures.

    FDA Recall
    Terminated ·Linvatec Corp. dba ConMed Linvatec·Product code KDC·January 28, 2010

    REF 8787, 7mm C-REAMER, CANNULATED, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Intended for use in Arthroscopic knee procedures.

    FDA Recall
    Terminated ·Linvatec Corp. dba ConMed Linvatec·Product code LXH·January 28, 2010

    REF 9906, DIGIT TRAP FINGER GRASPING DEVICE, STERILE. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Intended for use in small joint arthroscopic procedures.

    FDA Recall
    Terminated ·Linvatec Corp. dba ConMed Linvatec·Product code KDC·January 28, 2010

    REF 8586, 6mm C-REAMER, CANNULATED, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Intended for use in Arthroscopic knee procedures.

    FDA Recall
    Terminated ·Linvatec Corp. dba ConMed Linvatec·Product code LXH·January 28, 2010

    REF 70-0075-003, 3mm ARTHRO-KNIFE SHEATHED KNIFE, MINI-MENISCUS, STRAIGHT, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Intended for use in orthaepedic surgery where a cutting instrument is required.

    FDA Recall
    Terminated ·Linvatec Corp. dba ConMed Linvatec·Product code HRX·January 28, 2010

    REF, 9973, 2.4mm ARTHROSCOPY KNIFE, BANANA STYLE, SMALL JOINT, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Intended for proper tissue dissection in small joint procedures.

    FDA Recall
    Terminated ·Linvatec Corp. dba ConMed Linvatec·Product code HRX·January 28, 2010

    REF 70-0073-003, 3mm ARTHRO-KNIFE SHEATHED KNIFE, RETRO, STRAIGHT, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Intended for use in orthaepedic surgery where a cutting instrument is required.

    FDA Recall
    Terminated ·Linvatec Corp. dba ConMed Linvatec·Product code HRX·January 28, 2010

    REF 70-0072-003, 3mm ARTHRO-KNIFE SHEATHED KNIFE, HOOK, STRAIGHT, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Intended for use in orthaepedic surgery where a cutting instrument is required.

    FDA Recall
    Terminated ·Linvatec Corp. dba ConMed Linvatec·Product code HRX·January 28, 2010

    C-REAMER CANNULATED, STERILE, Rx ONLY. REF 8772A, 9.0MM, QTY DIST 712. REF 8773A, 10MM, QTY DIST 1,244. REF 8774A, 11MM, QTY DIST 384 REF 8775A, 12MM, QTY DIST 156 CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.

    FDA Recall
    Terminated ·Linvatec Corp. dba ConMed Linvatec·Product code LXH·January 28, 2010

    D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone

    FDA Recall
    Terminated ·Linvatec Corp. dba ConMed Linvatec·Product code GEY·January 24, 2013