BEUDAMED
    22 results · 28ms · Sources: EU EUDAMED, US FDA

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    ORTHO EASY PIN

    FDA 510(k)
    FDA Class 2 ·Dental

    SAV

    FDA UDI
    Diversified Products, Inc.·00842894116999·

    MAYO-NOBLE SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896020382·MAYO-NOBLE SCISSORS BEVELED BLADES CURVED TIP

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K1102250·Tray, Base, 2.25", Universal

    SI-LUTION Sacroiliac Joint Fusion System

    FDA UDI
    CURITEVA, INC.·B648C6151102750·3.2 X 275mm THREADED GUIDE PIN

    DRYSTAR 4500 PRINTER, MODEL 4500

    FDA 510(k)
    FDA Class 2 ·Radiology

    WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS

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

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·May 4, 2020

    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

    CADD SOLIS VIP PUMPS

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·June 3, 2022

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 13, 2013

    INRATIO PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·September 12, 2014

    GOBED II

    FDA Adverse Event
    Malfunction ·FLEXTRONICS EMS CANADA·Product code FNL·May 20, 2011

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·August 18, 2022

    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

    AR ManoShield, MSS-3599, 10 pack. FGS: MSS-3599, Individual package label: LBL-110275-03, Box label: LBL-110282-03, Package Inserts: DOC-3682, User Manual: DOC-1332-12. Product Usage: The MVS disposable sheath (a.k.a. ManoShield) for the high-resolution MVS catheter is designed to provide a biocompatible barrier between the catheter and patient.

    FDA Recall
    Terminated ·Sierra Scientific Instruments Inc·Product code FFX·October 12, 2011

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    Spectral CT. Computed tomography X-ray system.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 2, 2025