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

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    NS 120P-TRS Airway Pressure Gauge

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Bi-Metric XR-Series Hip System

    FDA UDI
    Biomet Orthopedics, LLC·00880304650763·

    COMPREHENSIVE REVERSE SHOULDER

    FDA UDI
    Biomet Orthopedics, LLC·00880304475502·

    Bernafon

    FDA UDI
    Bernafon AG·05711584075883·ZR7 MNR T, 2.4G NFM DPB SABE/MAC DEMO ZERENA 7

    Responsive Orthopedics Total Knee Arthroplasty System

    FDA UDI
    RESPONSIVE ORTHOPEDICS, LLC·00841973107071·TRIAL 90-SRK-180510 POLY PS 5X10MM

    VIP PULMONARY FUNCTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CERAMIR CROWN & BRIDGE

    FDA 510(k)
    FDA Class 2 ·Dental

    Specials

    FDA UDI
    Seaspine Orthopedics Corporation·10889981300975·Lollipop Trial, Right/Up-Angled, 18mm x 5mm x 5...

    Specials

    FDA UDI
    Seaspine Orthopedics Corporation·10889981301026·Lollipop Trial, Right/Down-Angled, 18mm x 5mm x...

    Specials

    FDA UDI
    Seaspine Orthopedics Corporation·10889981300920·Lollipop Trial, Anterior-Angled, 18mm x 5mm x 5...

    BD PRECISIONGLIDE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·July 19, 2022

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·COCHLEAR LTD.·Product code MCM·June 20, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 27, 2011

    ACRYSOF

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD/HUNTINGTON·Product code HQL·September 26, 2008

    T2 STRATOSPHERE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code MQP·July 1, 2020

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code MQP·October 30, 2017

    Poly Component Trial, PS, packaged in the following sizes and configurations: a) Poly Component Trial - PS 3x10, REF 90-SRK-180310 b) Poly Component Trial - PS 3x12, REF 90-SRK-180312 c) Poly Component Trial - PS 3x14, REF 90-SRK-180314 d) Poly Component Trial - PS 4x10, REF 90-SRK-180410 e) Poly Component Trial - PS 4x12, REF 90-SRK-180412 f) Poly Component Trial - PS 4x14, REF 90-SRK-180414 g) Poly Component Trial - PS 5x10, REF 90-SRK-180510 h) Poly Component Trial - PS 5x12, REF 90-SRK-180512 i) Poly Component Trial - PS 5x14, REF 90-SRK-180514 j) Poly Component Trial - PS 6x10, REF 90-SRK-180610 k) Poly Component Trial - PS 6x12, REF 90-SRK-180612 l) Poly Component Trial - PS 6x14, REF 90-SRK-180614 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, PS, packaged in the following sizes and configurations: a) Poly Component Trial - PS 3x10, REF 90-SRK-180310 b) Poly Component Trial - PS 3x12, REF 90-SRK-180312 c) Poly Component Trial - PS 3x14, REF 90-SRK-180314 d) Poly Component Trial - PS 4x10, REF 90-SRK-180410 e) Poly Component Trial - PS 4x12, REF 90-SRK-180412 f) Poly Component Trial - PS 4x14, REF 90-SRK-180414 g) Poly Component Trial - PS 5x10, REF 90-SRK-180510 h) Poly Component Trial - PS 5x12, REF 90-SRK-180512 i) Poly Component Trial - PS 5x14, REF 90-SRK-180514 j) Poly Component Trial - PS 6x10, REF 90-SRK-180610 k) Poly Component Trial - PS 6x12, REF 90-SRK-180612 l) Poly Component Trial - PS 6x14, REF 90-SRK-180614 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

    Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020