BEUDAMED
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    COMPUMEDICS NEUVO

    FDA 510(k)
    FDA Class 2 ·Neurology

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014609911·MIDMARK 4" SOFTCARE

    Theragenics

    FDA UDI
    THERAGENICS CORPORATION·00813787021850·

    IntroDucer

    FDA UDI
    Pajunk GmbH Medizintechnologie·04048223074619·IntroDucer 1,2 x 30mm for the Standard Sprotte...

    MICK 3mm Gold Fiduciary Marker 18 G Single

    FDA UDI
    MICK RADIO NUCLEAR INSTRUMENT, INC·00817330027740·

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code FGE·July 23, 2010

    EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ELECTROSURGICAL ELECTRODE FAMILY

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

    XACT CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIM·January 17, 2011

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code FGE·July 23, 2010

    ASR UNI FEMORAL IMPL SIZE 43

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·April 26, 2013

    CIC PRO CLINICAL INFORMATION CENTER

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code DSI·April 14, 2011

    DST SERIES EEA XL 31 MM

    FDA Adverse Event
    Malfunction ·COVIDIEN UNTIED STATES SURGICAL CORPORATION·Product code GDW·July 15, 2008

    PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code KRO·October 15, 2025

    PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code KRO·April 23, 2026

    BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231644 and 231645¿

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·February 14, 2024

    LGN PRSFT STEM 10MMX220MM STRT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·October 19, 2017

    LEGION HK HINGE KNEE SYSTEM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code KRO·March 15, 2025

    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

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