BEUDAMED
    22 results · 20ms · Sources: EU EUDAMED, US FDA

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    FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP

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

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925017610·SCHUKNECHT WIRE PISTON SLIM SHAFT .6MM DIAMETER...

    ELI 230 ELECTROCARDIOGRAPH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COOK URETERAL BALLOON DILATION CATHETER SET

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

    ROD, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019

    5.5 TI CANNULATED TRANSLATION SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·November 27, 2019

    IDENTITYT ADX XL DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CRMD·Product code DXY·January 13, 2014

    ADVIA CENTAUR XP CEA ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code DHX·May 31, 2013

    SYNCHRON® SYSTEMS RHEUMATOID FACTOR (RF) REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code DHR·June 25, 2011

    POLARIS SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·January 8, 2020

    PEDICLE SCREW UNSPECIFIED

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET SPINE INC.·Product code NKB·April 20, 2021

    PEDICLE SCREW UNSPECIFIED

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET SPINE INC.·Product code NKB·April 20, 2021

    PEDICLE SCREW UNKNOWN TYPE/SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·April 20, 2021

    CANNULATED TRANSLATION SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·December 3, 2020

    POLARIS TRANSLATION SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·November 27, 2019

    MENTOR SILTEX ROUND SPECTRUM

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·December 19, 2019

    Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. It is an undyed, monofilament synthetic absorbable suture with needle size 3/0.

    FDA Enforcement
    Class II ·Terminated·C P Medical, Inc.·November 5, 2014

    Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·July 16, 2014

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·September 24, 2014