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

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    Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

    FDA 510(k)
    FDA Class 1 ·General Hospital

    TYING FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896084612·MICRO FORCEPS STRAIGHT TUNGSTEN CARBIDE DUST TI...

    Vilex Jones Fracture Guidewire

    FDA UDI
    VILEX LLC·00841731123558·Wire, Guide 1.8x200mm Sgl Trocar

    Vilex Jones Fracture Guidewire

    FDA UDI
    VILEX LLC·00841731123084·Wire, Guide 1.8x200mm Sgl Trocar

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780182252·Integra® Jarit® Ford-Deaver Retractor, 16-1/2",...

    Initia Total Hip System

    FDA UDI
    KYOCERA CORPORATION·04547898306389·STD LINER 40-56/58

    ACCU-CHECK COMFORT CURVE

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code LFR·February 28, 2005

    NEUWAVE Microwave Ablation System and Accessories

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

    HARDYDISK, CARBENICILLIN, 100MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 28, 2025

    HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·October 24, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 10, 2011

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 1, 2013

    PHYSICA KR TIB. LINER RIGHT #5

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A·Product code MBH·December 21, 2022

    CONMED

    FDA Adverse Event
    Malfunction ·NORTHGATE TECHNOLOGIES INC.·Product code HIF·August 29, 2018

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

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