BEUDAMED
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    SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult

    FDA Enforcement
    Class II ·Terminated·Sharp Medical Products·April 14, 2021

    SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult

    FDA Recall
    Terminated ·Sharp Medical Products·Product code GCJ·February 8, 2021

    Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Sharp Needle 2.00" (5.08cm) Length, Product number P0118 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries

    FDA Enforcement
    Class II ·Terminated·Progressive Medical Inc·May 29, 2013

    Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Sharp Needle 2.00" (5.08cm) Length, Product number P0118 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries

    FDA Recall
    Terminated ·Progressive Medical Inc·Product code GEI·April 12, 2013

    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous access including, but not limited to the following: multiple infusions of fluids, medications, or chemotherapy; infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values; frequent blood sampling or blodd/blood component infusions; infusion of incompatible medications; central venous pressure monitoring; lack of usable peripheral IV sites; replacement of multiple peripheral sites for IV access

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 14, 2017

    Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous access including, but not limited to the following: multiple infusions of fluids, medications, or chemotherapy; infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values; frequent blood sampling or blodd/blood component infusions; infusion of incompatible medications; central venous pressure monitoring; lack of usable peripheral IV sites; replacement of multiple peripheral sites for IV access

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 14, 2017

    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous access including, but not limited to the following: multiple infusions of fluids, medications, or chemotherapy; infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values; frequent blood sampling or blodd/blood component infusions; infusion of incompatible medications; central venous pressure monitoring; lack of usable peripheral IV sites; replacement of multiple peripheral sites for IV access

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 14, 2017

    Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous access including, but not limited to the following: multiple infusions of fluids, medications, or chemotherapy; infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values; frequent blood sampling or blodd/blood component infusions; infusion of incompatible medications; central venous pressure monitoring; lack of usable peripheral IV sites; replacement of multiple peripheral sites for IV access

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 14, 2017

    Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to:  multiple infusions of fluids, medications, or chemotherapy  infusion of fluids that are hypertonic, hyperosmolar, or have  divergent pH values  frequent blood sampling or blood/blood component infusions  infusion of incompatible medications  central venous pressure monitoring  lack of usable peripheral IV sites  replacement of multiple peripheral sites for IV access  injection of contrast media  When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·March 21, 2018

    Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to:  multiple infusions of fluids, medications, or chemotherapy  infusion of fluids that are hypertonic, hyperosmolar, or have  divergent pH values  frequent blood sampling or blood/blood component infusions  infusion of incompatible medications  central venous pressure monitoring  lack of usable peripheral IV sites  replacement of multiple peripheral sites for IV access  injection of contrast media  When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI. Catheter and Sharps Safety Features

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·March 21, 2018

    Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to:  multiple infusions of fluids, medications, or chemotherapy  infusion of fluids that are hypertonic, hyperosmolar, or have  divergent pH values  frequent blood sampling or blood/blood component infusions  infusion of incompatible medications  central venous pressure monitoring  lack of usable peripheral IV sites  replacement of multiple peripheral sites for IV access  injection of contrast media  When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·March 21, 2018

    Product 53 consists of all product under: product code: JWH and same usage: Item no: 597002501 NEXGEN PRECOAT PEG TIB PL 597002502 NEXGEN PRECOAT PEG TIB PL 597003501 NEXGEN PRECOAT PEG TIB PL 597003502 NEXGEN PRECOAT PEG TIB PL 597004501 NEXGEN PRECOAT PEG TIB PL 597004502 NEXGEN PRECOAT PEG TIB PL 597005501 NEXGEN PRECOAT PEG TIB PL 597005502 NEXGEN PRECOAT PEG TIB PL 597005503 NEXGEN PRECOAT PEG TIB PL 597005504 NEXGEN PRECOAT PEG TIB PL 598002701 NEXGEN PRECOAT STEMMED TI 598002702 NEXGEN PRECOAT STEMMED TI 598003701 NEXGEN PRECOAT STEMMED TI 598003702 NEXGEN PRECOAT STEMMED TI 598004701 NEXGEN PRECOAT STEMMED TI 598004702 NEXGEN PRECOAT STEMMED TI 598005701 NEXGEN PRECOAT STEMMED TI 598005702 NEXGEN PRECOAT STEMMED TI 598005703 NEXGEN PRECOAT STEMMED TI 598005704 NEXGEN PRECOAT STEMMED TI 598801510 NEXGEN SHARP FLUTED STEM 598801511 NEXGEN SHARP FLUTED STEM 598801512 NEXGEN SHARP FLUTED STEM 598801513 NEXGEN SHARP FLUTED STEM 598801514 NEXGEN SHARP FLUTED STEM 598801515 NEXGEN SHARP FLUTED STEM 598801516 NEXGEN SHARP FLUTED STEM 598801517 NEXGEN SHARP FLUTED STEM 598801518 NEXGEN SHARP FLUTED STEM 598801519 NEXGEN SHARP FLUTED STEM 598801520 NEXGEN SHARP FLUTED STEM 598801010 NEXGEN STRAIGHT STEM EXT 598801011 NEXGEN STRAIGHT STEM EXT 598801012 NEXGEN STRAIGHT STEM EXT 598801013 NEXGEN STRAIGHT STEM EXT 598801014 NEXGEN STRAIGHT STEM EXT 598801015 NEXGEN STRAIGHT STEM EXT 598801016 NEXGEN STRAIGHT STEM EXT 598801017 NEXGEN STRAIGHT STEM EXT 598801018 NEXGEN STRAIGHT STEM EXT 598801020 NEXGEN STRAIGHT STEM EXT 598801022 NEXGEN STRAIGHT STEM EXT 598801024 NEXGEN STRAIGHT STEM EXT 598801112 NEXGEN STRAIGHT STEM EXT 598801113 NEXGEN STRAIGHT STEM EXT 598801114 NEXGEN STRAIGHT STEM EXT 598801115 NEXGEN STRAIGHT STEM EXT 598801116 NEXGEN STRAIGHT STEM EXT 598801117 NEXGEN STRAIGHT STEM EXT 598801118 NEXGEN STRAIGHT STEM EXT 598801212 NEXGEN STRAIGHT STEM EXT 598801215 NEXGEN STRAIGHT STEM EXT for use in total knee arthroplasty

    FDA Recall
    Terminated ·Product code JWH·January 11, 2016

    Merit Medical GmbH, Unomedical Ltd., Catheter Fixation Device StayFIX Fixation Device for Percutaneous Catheters Used to secure catheters in place without the use of sutures, reducing the exposure of sharps and sharp-related accidents.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code KGZ·September 29, 2009

    Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM STEM IMPLANT 24MMDX145MM SHARP FLUTED ST 20MMDX75MM SHARP FLUTED ST 22MMDX75MM SHARP FLTD ST 24MMDX75MM SHARP FLUTED ST 20MMDX130MM SHARP FLUTED ST 22MMDX130MM SHARP FLUTED ST 24MMDX130MM CEMENTED STEM EXT 13MM X 145MM IMPACTOR SLEEVE* NGK STEM EXT 12X245MM (200MM) NGK STEM EXT 13X245MM (200MM) NGK STEM EXT 14X245MM (200MM) NGK STEM EXT 15X245MM (200MM) NGK STEM EXT 16X245MM (200MM) NGK STEM EXT 17X245MM (200MM) NGK STEM EXT 18X245MM (200MM) NGK STEM EXT 20X245MM (200MM) NGK STEM EXT 22X245MM (200MM) SMOOTH REV STM 9.5MM X 19 SMOOTH REV STM 11.5MM X 1 SMOOTH REV STM 13.5MM X 1 SMOOTH REV STM 15.5MM X 1 SMOOTH REV STM 17.5MM X 1 REV FEM STM 10.5MM X 200M REV FEM STM 12.5MM X 200M REV FEM STM 14.5MM X 200M REV FEM STM 16.5MM X 200M 18.5X200MM REV STEM REV FEM STM 10.5MM X 250M REV FEM STM 12.5MM X 250M REV FEM STM 14.5MM X 250M REV FEM STM 16.5MM X 250M 12.5X155MM FLUTED OFFST R 14.5X155MM FLUTED OFFST R 16.5X155MM FLUTED OFFST R 18.5X155MM FLUTED OFFST R 20.5X155MM FLUTED OFFST R 12.5X175MM FLUTED REV STM FLUTE REV STEM - 14.5MM X FLUTE REV STEM - 16.5MM X FLUTE REV STEM - 18.5MM X FLUTE REV STEM - 20.5MM X FLUTE REV STEM - 22.5MM X FLUTED REV STM 10.5MM X 1 FLUTED REV STM 11.5MM X 1 FLUTED REV STM 12.5MM X 1 FLUTED REV STM 13.5MM X 1 FLUTED REV STM 14.5MM X 1 FLUTED REV STM 16.5MM X 1 FLUTED REV STM 18.5MM X 1

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code JWH·July 22, 2014

    Radial Artery Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when using the device.

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQX·August 8, 2016

    1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit 2) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features 3)Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue Plus (R) Catheter and Sharps Safety Features 4) Multi-Lumen Pressure Injectable Central Venous Catheterization Kit with Blue Flex Tip(R)ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features 5)Pressure Injectable ARROWg+ard Blue Plus (R) Multi-Lumen Central Venous Catheterization Kit 6)AGB+Multi-Lumen Central Venous Catheterization Kit 7) AGB+Pressure Injectable Multi-Lumen CVC Kit The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access. Catheter, Intravascular, Therapeutic, Short Term Less Than 30 days

    FDA Recall
    Terminated ·Arrow International Inc·Product code FOZ·May 9, 2017

    ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA Inc. business Unit: Ultrasound. The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging of the breast allows volumetric acquisition of the breast image.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYO·January 18, 2013

    da Vinci Xi Surgical System P4 software;with Xi Stapler; model number IS4000 : General and Plastic surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thorascopic surgical procedures and thorascopically-assisted cardiotomy procedures.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·August 17, 2015

    BD Beaver Mini-Blade, Blade Sharp Two Sides Pointed, Catalog Number: 376300

    FDA Recall
    Terminated ·Becton Dickinson and Company·Product code HNN·December 26, 2006

    BD Beaver Mini-Blade, Blade Mini Curved Sharp on One, Catalog Number: 376700

    FDA Recall
    Terminated ·Becton Dickinson and Company·Product code HNN·December 26, 2006