BEUDAMED
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    REPROCESSED FEMORAL COMPRESSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756612340·Wrist Splint

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481115851·Attachment System, 5.0mm/5.5mm/6.5mm Internal T...

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481123061·LOCATOR F-Tx Abutment for 5.0mm PrimaConnex Int...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450191286·

    TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODELS 8123, 8124, 8132, 8133, 8156, 8157, 8158, & 8189

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SONALIS

    FDA 510(k)
    FDA Class 2 ·Radiology

    UNKNOWN PRODUCT - SET SCREW

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HWC·October 12, 2012

    FITMORE, SHELL WITH SCREW CONES, UNCEMENTED, 54/JJ

    FDA Adverse Event
    Malfunction ·ZIMMER MANUFACTURING SWITZERLAND GMBH·Product code LZO·May 31, 2023

    ACTIVE ADAPTIVE

    FDA Adverse Event
    Injury ·MEDSHAPE, INC.·Product code HSB·March 11, 2025

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 25, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·June 6, 2011

    DURASUL, ALPHA INSERT, JJ/36

    FDA Adverse Event
    Malfunction ·ZIMMER MANUFACTURING SWITZERLAND GMBH·Product code LZO·April 14, 2023

    Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 20 mm - usable length 71mm - delivery system 16 FR; Catalog no. TFLE-20-71.

    FDA Recall
    Terminated ·Cook, Inc.·Product code MIH·June 10, 2004

    MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software

    FDA Enforcement
    Class II ·Ongoing·Auris Health, Inc·February 25, 2026

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016