BEUDAMED
    21 results · 31ms · Sources: EU EUDAMED, US FDA

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    ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Oticon

    FDA UDI
    Oticon A/S·05707131256669·NERA PRO, BTE 13 WL 85 CBE DEMO

    NexxZr™ T / D-100-20-NT-A350-SD

    FDA UDI
    SAGEMAX BIOCERAMICS, INC·00842271112491·

    ihcDirect® EpCAM Ab, 5mL

    FDA UDI
    NOVODIAX, INC.·00850000596610·Clone R1007

    ihcDirect® EpCAM Ab, 15mL

    FDA UDI
    NOVODIAX, INC.·00850000596634·Clone R1007

    ihcDirect® EpCAM Ab Conjugate 5mL

    FDA UDI
    NOVODIAX, INC.·00850030934635·Clone R1007

    ihcDirect® EpCAM Ab Conjugate 15mL

    FDA UDI
    NOVODIAX, INC.·00850030934642·Clone R1007

    COMPREHENSIVE LOCKING SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HWC·July 5, 2019

    IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER

    FDA 510(k)
    FDA Class 2 ·Hematology

    KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B

    FDA 510(k)
    FDA Class 2 ·Dental

    PRIMEADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 15, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 1, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    ASKU

    FDA Adverse Event
    Injury ·MEDTRONIC MILACA INC.·Product code DTE·June 16, 2011

    PRIMEADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 15, 2012

    PRIMEADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 8, 2012

    Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014