BEUDAMED
    27 results · 22ms · Sources: EU EUDAMED, US FDA

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    SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Radiology

    Novo Surgical

    FDA UDI
    NOVO SURGICAL, INC.·G586E1032750·lathbury cotton applicator, 5 1/2" (14.0 cm), t...

    SAV

    FDA UDI
    Diversified Products, Inc.·00037741210375·

    UNI-ELBOW

    FDA UDI
    Stryker GmbH·00886385026145·Radio Capitellum, Trial, Right, LG

    SYNTHES SYNMESH SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ASTRALIS 10, MODELS # 559588, 561859

    FDA 510(k)
    FDA Class 2 ·Dental

    REMSTAR AUTOA-FLEX

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·January 31, 2025

    HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code FAS·September 4, 2024

    RESTORE ADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 9, 2013

    RX ACCULINK CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIM·September 19, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 25, 2011

    HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 12°, STERILE, SINGLE USE

    FDA Adverse Event
    Injury ·OLYMPUS WINTER & IBE GMBH·Product code FAS·May 24, 2023

    HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 30°, STERILE, SINGLE USE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code FAS·June 6, 2023

    HF-RESECTION ELECTRODE, LOOP

    FDA Adverse Event
    Injury ·OLYMPUS WINTER & IBE GMBH·Product code FAS·June 2, 2023

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·February 27, 2024

    Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, Two Side Valves, Product Code 3266-E

    FDA Enforcement
    Class II ·Terminated·ConvaTec, Inc·June 14, 2017

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    Model Number L101, ESSENTIO DR SL Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025