BEUDAMED
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    Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W27 ST010 (b) NEO(R) 0.27 - 12 mm, REF W27 ST012 (c) DRP 0.27 - 12 mm, REF W27 ST012 (d) NEO(R) 0.27 - 14 mm, REF W27 ST014 (e) NEO(R) 0.27 - 16 mm, REF W27 ST016 (f) NEO(R) 0.27 - 18 mm, REF W27 ST018 (f) DRP 0.27 - 18 mm, REF W27 ST018 The NEOVIEW(R) Plating System is intended for fixation of intra-articular and extra-articular fractures of the distal radius and reconstruction of the distal radius. It is composed of a NEOVIEW" plate in PEEK and NE0411 screws in Ti6Al4V that are available in Locking or Non-Locking versions. The NEOVIEW411 Screw Set consists of a standard set of NE0411 screws with different lengths suitable for the implantation of a NEOVIEW9 plate for an average anatomy

    FDA Enforcement
    Class II ·Terminated·In2Bones, SAS·August 9, 2017

    SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius

    FDA Enforcement
    Class II ·Terminated·In2Bones, SAS·January 18, 2017

    Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W27 ST010 (b) NEO(R) 0.27 - 12 mm, REF W27 ST012 (c) DRP 0.27 - 12 mm, REF W27 ST012 (d) NEO(R) 0.27 - 14 mm, REF W27 ST014 (e) NEO(R) 0.27 - 16 mm, REF W27 ST016 (f) NEO(R) 0.27 - 18 mm, REF W27 ST018 (f) DRP 0.27 - 18 mm, REF W27 ST018 The NEOVIEW(R) Plating System is intended for fixation of intra-articular and extra-articular fractures of the distal radius and reconstruction of the distal radius. It is composed of a NEOVIEW" plate in PEEK and NE0411 screws in Ti6Al4V that are available in Locking or Non-Locking versions. The NEOVIEW411 Screw Set consists of a standard set of NE0411 screws with different lengths suitable for the implantation of a NEOVIEW9 plate for an average anatomy

    FDA Recall
    Terminated ·In2Bones, SAS 28 Chemin du petit Bois Ecully France·Product code HRS·July 13, 2017

    Non-continuous ventilator accessories under the following brand names: a) RP-ComfortGel Gel Cushion M model number 1009050; b) RP-ComfortGel Gel Cushion P model number 1009048; c) RP-ComfortGel Gel Cushion S model number 1009049; d) RP-ComfortGel Silicone Flap L model number 1009109; e) RP-ComfortGel Silicone Flap M model number 1009054; and f) RP-ComfortGel Silicone Flap S model number 1009053. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code BZD·October 15, 2007

    Continuous ventilator accessories under the following brand names: a) RP-Seal, Spring-5 pk model number F35465; b) RP-Seal, Greece, Ballscrew model number F35036; c) RP-Tub PVC 1/8 in x 50 ft model number 1008841; d) RP-Vision Filter Cover model number 1003444; e) RP-Vision RS-232 HRN ABV 106K model number 1004699; and f) RP-Wrap, Cord model number F35195. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code CBK·October 15, 2007

    Filters under the following brand names: a) filter std incoming 7100 CPAP qty 1 model number 1039618; b) filter reusable PLV 2/pkg model number 35220; c) LX UL Fine Filter 2 pack model number 1006193; d) RP-M Series Ultrafine Filters 6 pack model number 1029331; e) RP Vision OM Reg Filter (ASCO) model number 1007547; and f) REPL Filters package of 4 model number 929-4. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code BZD·October 15, 2007

    Monaco Radiation Treatment Planning System, Monaco Release 2.0.1 and above Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMRT) has been prescribed.

    FDA Recall
    Terminated ·Computerized Medical Systems Inc·Product code MUJ·May 31, 2010

    SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius

    FDA Recall
    Terminated ·In2Bones, SAS 28 Chemin du petit Bois Ecully France·Product code HRS·December 19, 2016

    The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KDI·January 7, 2021

    The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·March 10, 2021

    Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage: For Prismaflex Control Units, used for Continuous Renal Replacement Therapy (CRRT).

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·March 31, 2021

    Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KDI·January 28, 2021

    Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KDI·January 28, 2021

    Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KDI·January 28, 2021

    Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage: For Prismaflex Control Units, used for Continuous Renal Replacement Therapy (CRRT).

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KDI·January 28, 2021

    Power Supply under the following brand names: a) RP, Power Supply Assembly model number H3600-015, and b) RP, Wiring Harness, Lamp Holder model number H3600-020. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code BZD·October 15, 2007

    Non-continuous ventilator accessories under the following brand names: a) RP-L ComfortGel Cush and Flap model number 1031404 and b) RP-M ComfortGel Cush and Flap model number 1031403. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code BZD·October 15, 2007

    Non-continuous ventilator accessories under the following brand names: a) RP-P ComfortGel Cush and Flap model number 1031391 and b) RP-S ComfortGel Cush and Flap model number 1031392. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code BZD·October 15, 2007

    Non-continuous ventilator accessories under the following brand names: a) RP-BIPAP Flow Pick-Up Tube Kit model number 332185; b) RP-BIPAP M Series Keypad model number 1038122; and c) RP-BIPAP Pro 2 /Plus Tubing Kit model number 1020358. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code BZD·October 15, 2007

    CHROMagar VRE Base; 5000 ml (67.3 g/L) IVD; For InVitro Diagnostic Use; CHROMagar is a trademark of Dr. A Rambach; CHROMagar, Paris, France Medium for the detection of Van A Van B VRE. The majority of customers use this product for food, environmental, research or veterinarian use.

    FDA Recall
    Terminated ·DRG International Inc·Product code JSO·November 9, 2009