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

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    IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    A&E Medical / Thorecon™ 6 Hole Straight Plate (plate only)

    FDA UDI
    A & E MEDICAL CORPORATION·10841291107064·6 Hole Straight Plate (plate only)

    Monkey Rings™ External Fixation System

    FDA UDI
    Paragon 28, Inc.·00889795130402·Monkey Rings, Wire, Ø1.8mm x 500mm, Half Point

    MEDALLION MODULAR HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FLOSPINE PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COMP RVRS 25MM BSPLT HA+ADPTR R

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·October 15, 2020

    CONSTELLATION VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·June 3, 2014

    TRIDENT 0 DEG INSERT 36MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·February 4, 2013

    ACRYSOF

    FDA Adverse Event
    Other ·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·December 17, 2010

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code FGE·September 14, 2018

    3.2MM X 510MM COCR THD TIP; 14-443053 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 27, 2018

    PKG, BIOPSY FORCEPS, SPOON W/PIN, P/N 0250080291. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    PKG, BIOPSY FORCEPS, SPOON W/PIN, P/N 0250080291. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014