BEUDAMED
    22 results · 23ms · Sources: EU EUDAMED, US FDA

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    Focus 35C Detector, Trimax 35C Detector

    FDA 510(k)
    FDA Class 2 ·Radiology

    VERTE-STACK® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074520629·SPACER 9192512 CRESCENT PEEK 25X12

    Echo® Bi-Metric® Hip System

    FDA UDI
    Biomet Orthopedics, LLC·00887868273957·

    ECHO BI-METRIC HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304463011·

    Echo® Press-Fit Hip System

    FDA UDI
    Biomet Orthopedics, LLC·00887868260872·

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198758·AK3 Ultra Insert Trial Size 5, 12mm

    Integra® Miltex®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780506157·Integra® Miltex® House Oval Pick, 6-1/4", 0.33m...

    Responsive Orthopedics Total Knee Arthroplasty System

    FDA UDI
    RESPONSIVE ORTHOPEDICS, LLC·00841973108160·TRIAL 90-SRK-192512 POLY-MPCS 5X12 LEFT

    VANISHPOINT BLOOD COLLECTION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RMS SUBCUTANEOUS NEEDLE SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OPT SLEEVE 12X100 STABILITY

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·September 24, 2019

    HWAL ARCOMXL ALLPOLY 32IDX48OD

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·October 22, 2014

    PERIOSTEAL ELEVATOR, CURVED, 14MM WIDE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTE·June 27, 2013

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·August 5, 2011

    ECHO BIMETRIC STEM INSERTER

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LXH·August 7, 2023

    ECHO POR FEM RED LAT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·October 20, 2021

    M2A-MAGNUM PF CUP 52ODX46ID

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·October 9, 2018

    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

    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 Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code JWH·February 20, 2017

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014