BEUDAMED
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    Filters Classification: Class Ii × Status: Terminated × Clear all

    Poly Component Trial, MPCS, packaged in the following sizes and configurations: a) Poly Component Trial - MPCS 3x10L, REF 90-SRK-192310 b) Poly Component Trial - MPCS 3x10R, REF 90-SRK-191310 c) Poly Component Trial - MPCS 3x12L, REF 90-SRK-192312 d) Poly Component Trial - MPCS 3x12R, REF 90-SRK-191312 e) Poly Component Trial - MPCS 3x14L, REF 90-SRK-192314 f) Poly Component Trial - MPCS 3x14R, REF 90-SRK-191314 g) Poly Component Trial - MPCS 4x10L, REF 90-SRK-192410 h) Poly Component Trial - MPCS 4x10R, REF 90-SRK-191410 i) Poly Component Trial - MPCS 4x12L, REF 90-SRK-192412 j) Poly Component Trial - MPCS 4x12R, REF 90-SRK-191412 k) Poly Component Trial - MPCS 4x14L, REF 90-SRK-192414 l) Poly Component Trial - MPCS 4x14R, REF 90-SRK-191414 m) Poly Component Trial - MPCS 5x10L, REF 90-SRK-192510 n) Poly Component Trial - MPCS 5x10R, REF 90-SRK-191510 o) Poly Component Trial - MPCS 5x12L, REF 90-SRK-192512 p) Poly Component Trial - MPCS 5x12R, REF 90-SRK-191512 q) Poly Component Trial - MPCS 5x14L, REF 90-SRK-192514 r) Poly Component Trial - MPCS 5x14R, REF 90-SRK-191514 s) Poly Component Trial - MPCS 6x10L, REF 90-SRK-192610 t) Poly Component Trial - MPCS 6x10R, REF 90-SRK-191610 u) Poly Component Trial - MPCS 6x12L, REF 90-SRK-192612 v) Poly Component Trial - MPCS 6x12R, REF 90-SRK-191612 w) Poly Component Trial - MPCS 6x14L, REF 90-SRK-192614 x) Poly Component Trial - MPCS 6x14R, REF 90-SRK-191614 The Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint.

    FDA Enforcement
    Class II ·Terminated·Medtronic Sofamor Danek USA Inc·March 29, 2017

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018