BEUDAMED
    3,829 results · 25ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Profin

    FDA UDI
    Dentatus AB·07350081494834·Profin Hand Instrument with Assorted Lamineer T...

    C.A.P.D. AUTOMATIC HEATER PDH 200

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

    G-6-PDH NORMAL CONTROL (G-6-PDH CONTROL N)

    FDA UDI
    RANDOX LABORATORIES LIMITED·05055273204780·

    G-6-PDH DEFICIENT CONTROL (G-6-PDH CONTROL D)

    FDA UDI
    RANDOX LABORATORIES LIMITED·05055273204773·

    CERTIFIED DRUG FREE URINE 100ML

    FDA UDI
    UTAK LABORATORIES, INC.·B80088121CDFF100PDH0·CERTIFIED DRUG FREE URINE 100ML

    2124215-2011-20857

    FDA Adverse Event
    Injury ·GUIDANT PUERTO RICO BV·Product code LWS·January 12, 2012

    G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·May 8, 2019

    G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·May 8, 2019

    G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes

    FDA Recall
    Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JBL·April 3, 2019

    G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes

    FDA Recall
    Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JBL·April 3, 2019

    ILET BIONIC PANCREAS

    FDA Adverse Event
    Injury ·BETA BIONICS INC.·Product code QFG·January 16, 2026

    BRYAN CERVICAL DISC SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code MJO·June 10, 2011

    3.5MM LCP DISTAL TIBIA T-PLATE 5 HOLES/90MM

    FDA Adverse Event
    Injury ·SYNTHES ELMIRA·Product code HRS·January 26, 2015

    MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAT·February 8, 2021

    2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/6 HOLES/LEFT

    FDA Adverse Event
    Malfunction ·SYNTHES ELMIRA·Product code HRS·April 29, 2015

    Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.

    FDA Recall
    Terminated ·Beevers Manufacturing & Supply, Inc.·Product code PDH·July 11, 2014

    Blanket, Neonatal Phototherapy

    FDA classification
    FDA Class 2 ·Blanket, Neonatal Phototherapy

    ADHE-ELS INTERNATIONAL

    FDA registration
    ADHE-ELS INTERNATIONAL·1 product·🇹🇳 Tunisia

    PDC RESTORER, LLC

    FDA registration
    PDC RESTORER, LLC·1 product·🇺🇸 United States

    NDH MEDICAL, INC.

    FDA registration
    NDH MEDICAL, INC.·3 products·🇺🇸 United States