BEUDAMED
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    ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AGC DA2000 KN TIB BRG 71/75X8

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·April 9, 2026

    VANGUARD ROCC POR FEM S55 R

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code MBH·January 22, 2026

    VANGUARD ROCC POR FEM S57.5 L

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code MBH·January 22, 2026

    VANGUARD ROCC POR FEM S57.5 L

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code MBH·May 13, 2025

    TINBN VANGUARD INT PS ANAT FM R 75MM

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code MBH·June 4, 2025

    VANGUARD ROCC POR FEM S55 R

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code MBH·June 4, 2025

    ArgenZ HT+ 95x18 C4

    FDA UDI
    ARGEN CORPORATION, THE·D818122745·Dental porcelain/ceramic restoration kit

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010069689·STAINLESS STEEL HALF PIN 4MM X 45MM

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970508·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970478·

    V-14 CONTROL WIRE GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    XN CAL

    FDA 510(k)
    FDA Class 2 ·Hematology

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·May 21, 2013

    LCS COM RPSFLEX FEM CEM L STD+

    FDA Adverse Event
    Injury ·DEPUY (IRELAND)·Product code NJL·June 3, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 20, 2008

    SPECIFIC DEVICE NOT REPORTED

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·April 16, 2024

    UNITIP CATHETER FOR HR GI

    FDA Adverse Event
    Malfunction ·UNISENSOR USA INC·Product code FFX·January 16, 2015

    -90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue) 170mm. Ref. 7205441 Lot 122502 -Acromioplasty Electrode (Grey) 6.5" x 165mm. Ref. C5012A Lot 122288 -CAPSure 30 ArthroWand, CW, 30 Degree Shaft Angle, (Grey) 3.0mm. Ref. AC 1830-01 Lot 122494 -Coblator II Evac 70 Xtra Plasma Wand, w/Integrated Saline Line & Integrated Cable. Ref. EIC 5872-01 Lot 122295, 122308, 122626, 122325, -Coblator II, ENT ReFlex Ultra 45 w/Integrated Cable, (Blue). Ref. EIC 4845-01 Lot 122651, 122419, 122671, 122633 Electrosurgical cutting and coagulation device and accessories. -CoVac 50, Suction ArthroWand, w/Integrated Cable, (White/Grey). Ref. ASC 2530-01 Lot 122483, 122745 -CoVac 70, ICW ArthroWand 70 angle 3.0mm. Ref. ASC 3730-01 Lot 122483, -Eliminator, Right Angle ArthroWand (Beige). Ref. A 1345-01 Lot 122446 -Eliminator, Right Angle ArthroWand, 90 Degree w/Integrated Cable, (Grey) 4.5mm. Ref. AC 1345-01 Lot 122494, 122446 -ENT Coblator II PROcise XP Wand, w/Integrated Cable, Suction & Saline, (Blue). Ref. EIC 8872-01 Lot 122651, 122762 -Ligament Chisel Probe,Curved w/Integrated Cable, (Grey/Green). Ref. 7209647 Lot 122512 -LightWave Suction Ablator, 90 Degree, Hand Control, Multi-Angle, (Blue/White) 4.5mm x 142mm. Ref. IA-2000-S Lot 122512 -Lo-Pro 90 Degree ArthroWand, w/Integrated Cable, (Grey) 3.6mm. Ref. AC1336-01 Lot 122654, 122325 -Meniscectomy Electrode, Standard Design (Grey) 165mm. Ref. C5010A Lot 122765 -MeniVac ArthroWand w/Suction, w/Integrated Cable, (Grey) 3.0mm. Ref. ASC 5500-01 Lot 122630, 122494 -Microblastor 30 Wand, 30 Degree, w/Integrated Cable, (Grey) 0.9mm Tip. Ref. AC 40500-01 Lot 122293 -Right Angle ArthroWand, 90 Degree, w/Integrated Cable, (Grey) 3.5mm. Ref. AC 1340-01 Lot 123044, 122673 -Saber 30 ArthroWand, 30 Degree, w/Integrated Cable, (Grey) 3.0mm. Ref. AC 4330-01 Lot 122630, 122494, 123044, 122283, 122765 -SAPHYRE II Bipolar Ablation Probe, w/suction, High Profile 50 Degree, (Pewter). Ref. 7210112 Lot 122734 -SERFAS ENERGY Hook Probe 3.5mm. Ref. 279-350-501 Lot 123266 -Small Joint ArthroWand, Short Bevel 35, w/Integrated Cable, Suction (Grey/White) 2.3mm. Ref. AC 2823-01 Lot 122494, 122663 -StarVac ArthroWand, Short Bevel 35, w/Integrated Cable, Suction (Grey)5.5mm. Ref. ASC 4251-01 Lot 122630, 122593, 122483, 123044, 122283, 122595 -Super MultiVac 50, 50 Degree, w/Suction and Integrated Cable, (Grey/Black) 3.0mm. Ref. ASC 4830-01 Lot 122029, 123044, 122663 -Super TurboVac 90, 90 Degree Suction ArthroWand, (White/Grey) 3.5mm. Ref. ASC 4250-01 Lot 122029,122654, 122651, 122427, 122630, 122494, 122626, 122745, 122293, 122663, 122325, 122765 -TAC-C II Probe, w/Integrated Cable, (Blue/Grey). Ref. 7209628 Lot 122486 -TriStar 50 Suction ArthroWand, 50 Degree w/Integrated Cable, (White/Grey). Ref. ASC 4630-01 Lot 122283 -Turbinate, Tissue Coagulating Electrode, (White). Ref. 1120-4110-01 Lot 122486 -VAPR Hook Electrode W/Integrated Handpiece 3.5mm. Ref. 227305 Lot 122288, 122466 -VAPR LD, Suction Electrode, Large Diameter (Blue) 4.0mm. Ref. 225360 Lot 122512 -VAPR Premiere50-, w/Integrated Cable, Suction, (Black/White) 3.0mm. Ref. 227504 Lot 122029, 122455 -VAPR Premiere90 w/Suction tion, Integrated Cable, (Black/White) 3.3mm. Ref. 227204 Lot 122029, 122446, 122466, 122306, 122435, 122293, -VAPR S90 Suction Electrode, w/Integrated Cable, (Black/White). Ref. 225370 Lot 122577, 122455, 122593, 122288, 122466, 122589, 122356, 122639, 122325, 122318 -VAPR Side Effect Electrode (Blue) 3.5mm. Ref. 225301 Lot 122512 -VAPR Side Effect Electrode, w/Integrated Handpiece 3.5mm. Ref. 227301 Lot 122288, 122356, -VAPR Wedge Electrode (Short,) w/Integrated Cable (Black/White) 2.3mm x 85 mm. Ref. 227213 Lot 122409 -VAPR Wedge Electrode, w/Integrated Cable (Black/White) 2.3mm. Ref. 227203 Lot 122486, 122639 -VAPR Angled, Side Effect Electrode (Blue) 3.5mm. Ref. 225302 Lot 122512 -Vulcan Sa

    FDA Enforcement
    Class II ·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013

    -90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue) 170mm. Ref. 7205441 Lot 122502 -Acromioplasty Electrode (Grey) 6.5" x 165mm. Ref. C5012A Lot 122288 -CAPSure 30 ArthroWand, CW, 30 Degree Shaft Angle, (Grey) 3.0mm. Ref. AC 1830-01 Lot 122494 -Coblator II Evac 70 Xtra Plasma Wand, w/Integrated Saline Line & Integrated Cable. Ref. EIC 5872-01 Lot 122295, 122308, 122626, 122325, -Coblator II, ENT ReFlex Ultra 45 w/Integrated Cable, (Blue). Ref. EIC 4845-01 Lot 122651, 122419, 122671, 122633 Electrosurgical cutting and coagulation device and accessories. -CoVac 50, Suction ArthroWand, w/Integrated Cable, (White/Grey). Ref. ASC 2530-01 Lot 122483, 122745 -CoVac 70, ICW ArthroWand 70 angle 3.0mm. Ref. ASC 3730-01 Lot 122483, -Eliminator, Right Angle ArthroWand (Beige). Ref. A 1345-01 Lot 122446 -Eliminator, Right Angle ArthroWand, 90 Degree w/Integrated Cable, (Grey) 4.5mm. Ref. AC 1345-01 Lot 122494, 122446 -ENT Coblator II PROcise XP Wand, w/Integrated Cable, Suction & Saline, (Blue). Ref. EIC 8872-01 Lot 122651, 122762 -Ligament Chisel Probe,Curved w/Integrated Cable, (Grey/Green). Ref. 7209647 Lot 122512 -LightWave Suction Ablator, 90 Degree, Hand Control, Multi-Angle, (Blue/White) 4.5mm x 142mm. Ref. IA-2000-S Lot 122512 -Lo-Pro 90 Degree ArthroWand, w/Integrated Cable, (Grey) 3.6mm. Ref. AC1336-01 Lot 122654, 122325 -Meniscectomy Electrode, Standard Design (Grey) 165mm. Ref. C5010A Lot 122765 -MeniVac ArthroWand w/Suction, w/Integrated Cable, (Grey) 3.0mm. Ref. ASC 5500-01 Lot 122630, 122494 -Microblastor 30 Wand, 30 Degree, w/Integrated Cable, (Grey) 0.9mm Tip. Ref. AC 40500-01 Lot 122293 -Right Angle ArthroWand, 90 Degree, w/Integrated Cable, (Grey) 3.5mm. Ref. AC 1340-01 Lot 123044, 122673 -Saber 30 ArthroWand, 30 Degree, w/Integrated Cable, (Grey) 3.0mm. Ref. AC 4330-01 Lot 122630, 122494, 123044, 122283, 122765 -SAPHYRE II Bipolar Ablation Probe, w/suction, High Profile 50 Degree, (Pewter). Ref. 7210112 Lot 122734 -SERFAS ENERGY Hook Probe 3.5mm. Ref. 279-350-501 Lot 123266 -Small Joint ArthroWand, Short Bevel 35, w/Integrated Cable, Suction (Grey/White) 2.3mm. Ref. AC 2823-01 Lot 122494, 122663 -StarVac ArthroWand, Short Bevel 35, w/Integrated Cable, Suction (Grey)5.5mm. Ref. ASC 4251-01 Lot 122630, 122593, 122483, 123044, 122283, 122595 -Super MultiVac 50, 50 Degree, w/Suction and Integrated Cable, (Grey/Black) 3.0mm. Ref. ASC 4830-01 Lot 122029, 123044, 122663 -Super TurboVac 90, 90 Degree Suction ArthroWand, (White/Grey) 3.5mm. Ref. ASC 4250-01 Lot 122029,122654, 122651, 122427, 122630, 122494, 122626, 122745, 122293, 122663, 122325, 122765 -TAC-C II Probe, w/Integrated Cable, (Blue/Grey). Ref. 7209628 Lot 122486 -TriStar 50 Suction ArthroWand, 50 Degree w/Integrated Cable, (White/Grey). Ref. ASC 4630-01 Lot 122283 -Turbinate, Tissue Coagulating Electrode, (White). Ref. 1120-4110-01 Lot 122486 -VAPR Hook Electrode W/Integrated Handpiece 3.5mm. Ref. 227305 Lot 122288, 122466 -VAPR LD, Suction Electrode, Large Diameter (Blue) 4.0mm. Ref. 225360 Lot 122512 -VAPR Premiere50-, w/Integrated Cable, Suction, (Black/White) 3.0mm. Ref. 227504 Lot 122029, 122455 -VAPR Premiere90 w/Suction tion, Integrated Cable, (Black/White) 3.3mm. Ref. 227204 Lot 122029, 122446, 122466, 122306, 122435, 122293, -VAPR S90 Suction Electrode, w/Integrated Cable, (Black/White). Ref. 225370 Lot 122577, 122455, 122593, 122288, 122466, 122589, 122356, 122639, 122325, 122318 -VAPR Side Effect Electrode (Blue) 3.5mm. Ref. 225301 Lot 122512 -VAPR Side Effect Electrode, w/Integrated Handpiece 3.5mm. Ref. 227301 Lot 122288, 122356, -VAPR Wedge Electrode (Short,) w/Integrated Cable (Black/White) 2.3mm x 85 mm. Ref. 227213 Lot 122409 -VAPR Wedge Electrode, w/Integrated Cable (Black/White) 2.3mm. Ref. 227203 Lot 122486, 122639 -VAPR Angled, Side Effect Electrode (Blue) 3.5mm. Ref. 225302 Lot 122512 -Vulcan Sa

    FDA Recall
    Terminated ·Surgical Instrument Service And Savings, Inc.·Product code GEI·May 3, 2013