BEUDAMED
    67 results · 13ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    DePuy Synthes TI Vectra Plates: TI Vectra-One" Plate 2 Level / 34 mm part 04.613.184 3337672 TI Vectra" Plate 3 Level / 57 mm part 04.613.257 lot 3693878 TI Vectra" Plate 4 Level / 64 mm part 04.613.364 lot 8143905

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·October 1, 2014

    Part #311.039, Handle with Mini QC Small, Lot # 4401497, 4687440, 4687441, 5639684, 4415131,4663839, 5623098 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 20, 2016

    Part # 313.232, 2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC, lot # 4363820, mfg. 9/11/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 20, 2016

    Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 20, 2016

    Part # 313.212, 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC, Lot # 4363780, mfg. 9/18/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 20, 2016

    Part # SD313.011, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Short, Lot # UR75220, mfg 7/18/2007 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 20, 2016

    Part # 313.946, Low Profile Neuro Screwdriver Blade/MR Safe/MQC/56mm Medium, Lot # 5053374, mfg 7/27/2005 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 20, 2016

    Part # SD313.012, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Med, lot # UR75221 & UR80162, mfg 7/18/2007-8/2/2007 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 20, 2016

    Part #313.231, 2.0mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341036, 4363819, 4427699, mfg. 3/4/2002-6/6/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 20, 2016

    Part # 313.211, 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341031, 4363779, 4427697, mfg. 2/28/2002-6/6/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 20, 2016

    Screwdriver Blade, Handle, Drill Bit, Part #313.945 Low Profile Neuro Screwdriver Blade/MR Safe/MQC/32mm Short Lot # 5053859 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 20, 2016

    Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033, 4589566, 4703774, 4363781, 4589567, 4793575, 4904305, 4427700,4589568, 4830581, 4532370, 4673943, 4871657, mfg. 2/12/2002-5/23/2005 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 20, 2016

    Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·April 6, 2016

    DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Subtrochanteric fractures, Ipsilateral neck/shaft fractures, Femoral shaft fractures, Impending pathologic fractures, and malunions/Non-unions.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 8, 2015

    Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide Sleeve, Surgical Instrument Part Number ID 03.037.017, Class I exempt Lot Numbers: 9066399; 9066435; 9409790; 9519308; 9620447; 9301183; 9409792; 9519303; 9641077; 9301184; 9409791; 9542998; 9641078; 9327510; 9422885; 9554330; 9651850; 9340629; 9351396; 9554329; 9604307; 9347642; 9428332; 9533341; 9661610; 9339162; 9439269; 9574931; 9734868; 9347641; 9485532; 9569618; 9704087; 9351397; 9485534; 9569617; 9734876; 9359540; 9494322; 9590744; 9661608; 9359339; 9501935; 9590747; 9371095; 9505477; 9604306 These devices are specific to the Trochanteric Fixation Nail Advanced (TFNA) system. The TFNA Proximal Femoral Nailing System is for the treatment of intramedullary fixation of proximal femoral fractures

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 27, 2016

    Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·November 25, 2015

    DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001

    FDA Enforcement
    Class II ·Ongoing·Synthes (USA) Products LLC·October 26, 2022

    DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·October 29, 2014

    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.

    FDA Enforcement
    Class II ·Ongoing·DEPUY (IRELAND)·May 6, 2026

    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207.

    FDA Enforcement
    Class II ·Ongoing·DEPUY (IRELAND)·May 6, 2026