BEUDAMED
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    Allura Xper Systems Models: Allura Xper FD10 (F/C)-Biplane Fixed Allura Xper FD10/10 (incl. OR table) Allura Xper FD20- High resolution fixed-x ray Allura Xper FD20/10 Allura Xper FD20/20 Allura CV20 The Allura Xper F010, FD10/10, FD20, FD20/10 and FD20/20 Use From Labeling): is intended for use in cardiovascular and vascular X-ray imaging applications. including diagnostic,interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). The Allura Xper is intended for: Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral. thoracic and abdominal angiography, as well as PTCAs. stent placements, embolisations and thrombolysis. and Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and Electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Use of the Allura Xper FD Series in the OR environment is restricted; the system should only be used for minimally invasive procedures. (Endovascular)

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code IZI·July 8, 2011

    ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2

    FDA Recall
    Terminated ·Horiba Instruments, Inc dba Horiba Medical·Product code JQP·September 20, 2012

    Monitor for the Functional Imaging System for Magnetic Resonance Imaging System

    FDA Recall
    Terminated ·Invivo Corporation·Product code LNH·February 6, 2020

    Persona (TM) The Personalized Knee System PS Tibial Articular Surface Provisional Top Nonsterile TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 J TOP TASP PS L 10-12 J TOP TASP PS L 10-12 J TOP TASP PS L 10-12 J TOP TASP PS L 10-12 J TOP TASP PS L 10-12 J TOP TASP PS L 10-12 J TOP

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·August 27, 2014

    Cyto-Stat Tetra Chrome CD45-FITC/CD56-RD-1/CD-19-ECD/CD3-PC5 Monoclonal Antibody Reagent

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code GKZ·August 26, 2003

    VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 2000 tests, IVD, Made in United States. Kit contains: 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer 2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer 3. Cartridge Set, 2 cation exchange analytical cartridges, 5 cation exchange Guard cartridges. 4. CD-ROM 1 - CD Rom with program parameters 5. Calibration/Diluent set - 2 levels, 3 vials each of lyophilized human red blood cell hemolysate with preservative, 1 bottle diluent, 100 mL deionized water. 6. Whole Blood Primer, 6 x 1 mL, lyophilized human red blood cell hemolysate with preservative, 7. Sample vials - 2 x 100, 1.5 mL polypropylene vials with pierceable caps. 8. Instruction Manual. Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)

    FDA Recall
    Terminated ·Bio-Rad Laboratories, Inc.·Product code LCP·September 12, 2011

    VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, Made in United States. Kit contains: 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer 2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer 3. Cartridge Set, 2 cation exchange analytical cartridges, 4 cation exchange Guard cartridges. 4. CD-ROM 1 - CD Rom with program parameters 5. Calibration/Diluent set - 2 levels, 2 vial each of lyophilized human red blood cell hemolysate with preservative, 1 bottle diluent, 100 mL deionized water. 6. Whole Blood Primer, 6 x 1 mL, lyophilized human red blood cell hemolysate with preservative, 7. Sample vials - 2 x 100, 1.5 mL polypropylene vials with pierceable caps. 8. Instruction Manual. Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)

    FDA Recall
    Terminated ·Bio-Rad Laboratories, Inc.·Product code LCP·September 12, 2011

    PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial Articular Surface Provisional TOP with the following: L 3-5 CD; L 6-9 CD; L 3-5 EF; L 6-9 EF; L 10-11 EF; L 6-9 GH; L 10-12 GH; L 10-12 J; R 3-5 CD; R 6-9 CD; R 3-5 EF; R 6-9 EF; R 10-11 EF; R 6-9 GH; R 10-12 GH; and R 10-12 J.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 10, 2014

    PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional Left Size 3-7 CD Top; Left Size 4-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12 J Top; Right Size 3-7 CD Top; Right Size 4-11 EF Top; Right Size 7-12 GH Top; and Right Size 9-12 J Top.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 10, 2014

    PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional Left with Size 3-5 CD Top; Size 6-9 CD Top; Size 3-5 EF Top; Size 6-9 EF Top; Size 10-11 EF Top; Size 6-9 GH Top; Size 10-12 GH Top; Size 10-12 J Top; and RIGHT Size 3-5 CD Top; Right Size 6-9 CD Top; Right Size 3-5 EF Top; Right Size 6-9 EF Top; Right Size 10-11 EF Top; Right Size 6-9 GH Top; Right Size 10-12 GH Top; and Right Size 10-12 J Top.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 10, 2014

    Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Provisional Top Nonsterile TASP MLC L 3-5 CD TOP TASP MLC L 6-9 CD TOP TASP MLC L 3-5 EF TOP TASP MLC L 6-9 EF TOP TASP MLC L 10-11 EF TOP TASP MLC L 6-9 GH TOP

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·August 27, 2014

    Persona (TM) The Personalized Knee System UC Tibial Articular Surface Provisional Top Nonsterile TASP UC L 3-7 CD TOP TASP UC L 4-11 EF TOP TASP UC L 7-12 GH TOP TASP UC L 9-12 J TOP

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·August 27, 2014

    PERSONA The Personalized Knee System Tibial Articular Surface Provisional Left with the following: Size CD +0 mm Thickness Bottom(TB); Size CD +6 mm Thickness Bottom; Size EF +0 mm Thickness Bottom; Size EF +6 mm TB; Size GH +0 mm TB; Size GH +6 mm TB; Size J +0 mm TB; Size J +6 mm TB; Right Size 1-2 CD +0 mm TB; Right Size CD +6 mm TB; Right Size EF +0 mm TB; Right Size EF +6 mm TB; Right Size GH +0 mm TB; Right Size GH +6 mm TB; Right Size J +0 mm TB; and Right Size J +6 mm TB.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code JWH·August 7, 2014

    VARIANT B-thalassemia Short Program Reorder Pack, 250 Tests, For the separation and determination os HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made in United States. Contents: 1. Elution Buffer 1, 2 x 1900 mL sodium phosphate buffer 2. Elution Buffer 2, 1 x 1800 mL sodium phosphate buffer 3. Wash/Diluent solution, 1 x 1800 mL deionized water 4. Analytical cartridge, 1 cation exchange cartridge 5. 1 Calibrator/Diluent set, 1 Lypholized human red blood cells hemolysate with preservative; deionized water with preservative 6. 1 CD Rom - CD R with program parameters 7 Sample vials, 100 x 1.5 mL. Sample vials with pierceable cap 8. Whole Blood Primer, 10 x 1.0 mL (3), Lypholized human red blood cells hemolysate with preservative; 9. Instruction Manual Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)

    FDA Recall
    Terminated ·Bio-Rad Laboratories, Inc.·Product code LCP·September 12, 2011

    VARIANT B-thalassemia Short Program Reorder Pack, 500 Tests, For the separation and determination of HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made in United States. Contents: 1. Elution Buffer 1, 3 x 1900 mL sodium phosphate buffer 2. Elution Buffer 2, 2 x 1800 mL sodium phosphate buffer 3. Wash/Diluent solution, 2 x 1800 mL deionized water 4. Analytical cartridge, 1 cation exchange cartridge 5. 1 Calibrator/Diluent set, 1 Lypholized human red blood cells hemolysate with preservative; deionized water with preservative 6. 1 CD Rom - CD R with program parameters 7 Sample vials, 100 x 1.5 mL. Sample vials with pierceable cap 8. Whole Blood Primer, 10 x 1.0 mL (3), Lypholized human red blood cells hemolysate with preservative; 9. Instruction Manual Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)

    FDA Recall
    Terminated ·Bio-Rad Laboratories, Inc.·Product code LCP·September 12, 2011

    VARIANT II TURBO LINK Hemoglobin A1c Program Reorder Pack, 1600 tests. For the determination of Hemoglobin A1c in human whole blood. Contents: 1. Elution Buffer A, 1 x 2500 mL Bis-Tris Phosphate Buffer 2. Elution Buffer B, 1 x 2100 mL Bis-Tris Phosphate Buffer 3. Wash/Diluent Solution, 1 x 2500 mL, Deionized water 4. Cartridge set - 2 cations exchange Analytical Cartridges, 4 cation exchange guard cartridges 5. CD-ROM 1, CD Rom with program parameters 6. Calibrator/Diluent Set, 2 levels, 2 vials each of lyophilized human red blood cell hemolysate with preservative, 1 bottle of diluent, 100 mL deionized water. 7. Whole Blood Primer, 6 x 1 mL, Lyophilized human red blood cell hemolysate with preservative 8. Sample Vials, 2 x 100, Polypropylene vials with pierceable lids 9. Instruction Manual. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC) Made in United States. Bio-Rad Laboratories, Hercules, CA 94547.

    FDA Recall
    Terminated ·Bio-Rad Laboratories, Inc.·Product code LCP·September 12, 2011

    PERSONA The Personalized Knee System Tibial Articular Surface Provisional Left with the following: Size CD +0 mm Thickness Bottom(TB); Size CD +6 mm Thickness Bottom; Size EF +0 mm Thickness Bottom; Size EF +6 mm TB; Size GH +0 mm TB; Size GH +6 mm TB; Size J +0 mm TB; Size J +6 mm TB; Right Size 1-2 CD +0 mm TB; Right Size CD +6 mm TB; Right Size EF +0 mm TB; Right Size EF +6 mm TB; Right Size GH +0 mm TB; Right Size GH +6 mm TB; Right Size J +0 mm TB; and Right Size J +6 mm TB.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 10, 2014

    Cook Harrison fetal bladder stent set, sterile; REF J-HFBS-503540.

    FDA Recall
    Terminated ·Cook Urological, Inc.·Product code FAD·March 1, 2006

    Boston Scientific 25ga (0.52mm) Expect Endoscopic Ultrasound Aspiration Needle REF 5002 Use By 1999-12 LOT 13615651C1 STERILE EO The Expect Needle is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FCG·August 11, 2011

    Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/24 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-060024-10-13; GPN REF G18132. Ureteral stent.

    FDA Recall
    Terminated ·Vance Products Incorporated·Product code FAD·July 31, 2008