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    KONTACT

    FDA UDI
    BIOTECH DENTAL·03701045243779·Prosthesis Kit

    Dri-Scope Aid - Cabinet (or TRACKER) - Kink Prevention Kit

    FDA UDI
    TRICOR SYSTEMS, INC.·00810053600979·Dri-Scope Aid Cabinet (or TRACKER); Kink Preven...

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    FDA UDI
    COLLEGE PARK INDUSTRIES, INC.·00195411451135·Icon Knee Pad Replacement Kit

    KION

    FDA Adverse Event
    Malfunction ·SIEMENS ELEMA AB / LIFE SUPPORT SYSTEMS DIVISION·Product code BSZ·October 13, 2000

    Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOTIC CDS b. DAVINCI CDS UCC-LF c. ROBOTICS PACK-LF d. ROBOTICS PACK-LF e. ROBOTIC PACK f. PELVISCOPY PACK-LF g. CUSTOM LITHOTOMY ROBOT PACK h. PERI GYN PACK i. ROBOTICS PACK j. LAP HYSTO PACK k. PK, ROBOTICS-ACCESSORY l. OBS PACK m. LAPAROSCOPY/D&C PACK n. PERI GYN RECTAL PACK o. TVT p. DAVINCI DT-LF q. ROBOTICS SI

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023

    Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOTIC CDS b. DAVINCI CDS UCC-LF c. ROBOTICS PACK-LF d. ROBOTICS PACK-LF e. ROBOTIC PACK f. PELVISCOPY PACK-LF g. CUSTOM LITHOTOMY ROBOT PACK h. PERI GYN PACK i. ROBOTICS PACK j. LAP HYSTO PACK k. PK, ROBOTICS-ACCESSORY l. OBS PACK m. LAPAROSCOPY/D&C PACK n. PERI GYN RECTAL PACK o. TVT p. DAVINCI DT-LF q. ROBOTICS SI

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OKV·November 17, 2022

    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAM TRAY, Model Number: DYNJ33638J; b. BLOCK TRAY, Model Number: DYNJRA1543; c. BMT- NERVE PERIPH PK, Model Number: DYNJRA1247; d. CVOR ANGIOGRAPHY PACK-LF, Model Number: DYNJ42367B; e. FEMORAL BLOCK TRAY, Model Number: DYNJRA1739; f. NERVE BLOCK ACCESSORY PACK, Model Number: DYNJ0134147D; g. NERVE BLOCK PREP TRAY, Model Numbers: DYNJRA1220, DYNJRA1571; h. NERVE BLOCK SUPPORT TRAY, Model Number: DYNJRA1109A; i. NERVE BLOCK TRAY, Model Numbers: DYNJRA0656A, DYNJRA1287A, DYNJRA1604; j. NERVE BLOCK TRAY/PREFERRED, Model Number: DYNJRA0725; k. PK, RADIOLOGY-NEURO-IR, Model Number: DYNJ51107B; l. SINGLE SHOT NERVE BLOCK TRAY, Model Number: DYNJRA1773; m. ULTRASOUND BLOCK PREP TRAY, Model Number: PAIN1622A; n. UNIVERSAL BLOCK TRAY/2, Model Number: DYNJRA1635A;

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 9, 2023

    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAM TRAY, Model Number: DYNJ33638J; b. BLOCK TRAY, Model Number: DYNJRA1543; c. BMT- NERVE PERIPH PK, Model Number: DYNJRA1247; d. CVOR ANGIOGRAPHY PACK-LF, Model Number: DYNJ42367B; e. FEMORAL BLOCK TRAY, Model Number: DYNJRA1739; f. NERVE BLOCK ACCESSORY PACK, Model Number: DYNJ0134147D; g. NERVE BLOCK PREP TRAY, Model Numbers: DYNJRA1220, DYNJRA1571; h. NERVE BLOCK SUPPORT TRAY, Model Number: DYNJRA1109A; i. NERVE BLOCK TRAY, Model Numbers: DYNJRA0656A, DYNJRA1287A, DYNJRA1604; j. NERVE BLOCK TRAY/PREFERRED, Model Number: DYNJRA0725; k. PK, RADIOLOGY-NEURO-IR, Model Number: DYNJ51107B; l. SINGLE SHOT NERVE BLOCK TRAY, Model Number: DYNJRA1773; m. ULTRASOUND BLOCK PREP TRAY, Model Number: PAIN1622A; n. UNIVERSAL BLOCK TRAY/2, Model Number: DYNJRA1635A;

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OGJ·May 15, 2023

    Marker, Ostia, Aorto-Saphenous Vein

    FDA classification
    FDA Class 2 ·Marker, Ostia, Aorto-Saphenous Vein

    HPK INDUSTRIES

    FDA registration
    HPK INDUSTRIES·5 products·🇺🇸 United States

    LACTO 1.5 2X2 SQUARE PLATE

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·October 6, 2025

    LACTO SCR 1.5X4MM 1.5 SYS 2PK

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·October 6, 2025

    LACTO SCR 1.5X4MM 1.5 SYS 2PK

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·October 6, 2025

    LACTO SCR 1.5X4MM 1.5 SYS 2PK

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·October 6, 2025

    LACTO SCR 1.5X4MM 1.5 SYS 2PK

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·October 6, 2025

    MARCHON JAPAN K.K.

    FDA registration
    MARCHON JAPAN K.K.·3 products·🇯🇵 Japan

    KOBAYASHI SHOJI K.K.

    FDA registration
    KOBAYASHI SHOJI K.K.·5 products·🇯🇵 Japan

    Cardinal Health K.K.

    FDA registration
    Cardinal Health K.K.·10 products·🇯🇵 Japan

    KATO KOGEI,K.K

    FDA registration
    KATO KOGEI,K.K·2 products·🇯🇵 Japan

    INFELD OPTICA K.K

    FDA registration
    INFELD OPTICA K.K·2 products·🇯🇵 Japan