BEUDAMED
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    SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIO-MODULAR REVERSE SHOULDER

    FDA UDI
    Biomet Orthopedics, LLC·00880304591219·

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837045807·Paddle Shaver, 16mm

    MICROLIFE DIGITAL UNDERARM THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CARBODISSECTING ENDOSCOPE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    GLADIATOR¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·March 6, 2012

    0113680-COMPOSIX MESH 6 X8

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (PUERTO RICO)·Product code FTL·February 28, 2001

    MEDEX 4-WAY STOPCOCK EXTENSION SET

    FDA Adverse Event
    Malfunction ·ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V·Product code FPK·September 29, 2025

    0113680-COMPOSIX MESH 6 X 8

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (PUERTO RICO)·Product code FTL·November 12, 2003

    0113680-COMPOSIX MESH 6 X 8

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (PUERTO RICO)·Product code FTL·October 30, 2000

    0113680-COMPOSIX MESH 6 X 8

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (PUERTO RICO)·Product code FTL·April 24, 2001

    0113680-COMPOSIX MESH 6 X 8

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (PUERTO RICO)·Product code FTL·August 7, 2001

    NITE GUARD

    FDA Adverse Event
    Malfunction ·RANIR LLC·Product code OBR·May 1, 2014

    ILAB ULTRASOUND IMAGING SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - FREMONT (CE)·Product code IYO·May 15, 2013

    ENDOPATH** XCEL* BLADELESS TROCAR

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·June 3, 2011

    MESH - COMPOSIX

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·January 23, 2018

    MESH - COMPOSIX

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·March 6, 2018

    Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-HQ190I, CF-HQ190L, CF-LV1I, CF-LV1L, CF-Q150I, CF-Q150L, CF-Q160S, CF-Q180AI, CF-Q180AL. 510(k) Numbers: K954451, K112680, K100584, K051645, K111756, K001241, K911278.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Bio-modular reverse shoulder humeral tray with lock ring, 44 mm standard, sterile, single use, REF 11-113680, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code KWS·April 22, 2011