BEUDAMED
    21 results · 27ms · Sources: EU EUDAMED, US FDA

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    TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004

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

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00312251·

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526780774·LEVAMED ACTIVE ANKLE SUP SLVR L V

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0112250·Tap, 7.50mm, Cannulated, Fixed Sleeve

    PROCEED MULTI-LAYER LAMINATE MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·June 16, 2006

    INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U.

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PROCEED MULTI-LAYER LAMINATE MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·June 26, 2006

    PROCEED MULTI-LAYER LAMINATE MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·June 26, 2006

    PROCEED MULTI-LAYER LAMINATE MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·June 27, 2006

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 25, 2022

    ECOIN PERIPHERAL NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·VALENCIA TECHNOLOGIES CORPORATION·Product code QPT·July 24, 2025

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIQ·April 2, 2013

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·March 28, 2011

    CARPENTIER-EDWARDS PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code LWR·April 15, 2008

    SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.

    FDA Enforcement
    Class II ·Terminated·Sirtex Medical Limited·March 24, 2021

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

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

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code EOQ·September 25, 2023

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016