BEUDAMED
    26 results · 23ms · Sources: EU EUDAMED, US FDA

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    AERO CHROME* Breathable Performance Surgical Gowns

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

    Pantheon System

    FDA UDI
    ADLER ORTHO SPA·08050880237784·Pantheon Salvage Cementless Stem L 115 Ø 22

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694006811·Reduction Forceps

    BABY MIXTER FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896060982·BABY MIXTER FORCEPS RIGHT ANGLED SERRATED JAWS

    K-Wire

    FDA UDI
    Treace Medical Concepts, Inc.·00810111227278·K-Wire

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180102606·BIPOLAR RF-CABLE WITH ELMED (DIN) INSTRUMENT CO...

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776147778·Dual 12ft Bipolar RF Cable with DIN instrument ...

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613122461·Bipolar Cord, Europe Style DIN Instrument End C...

    SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNK CUP

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·December 26, 2019

    G7 HI-WALL ARCOMXL LNR 40MM I

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LZO·December 26, 2019

    G7 HI-WALL E1 LINER 40MM I

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LZO·December 26, 2019

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 24, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    POWERED PATIENT ROTATION BED

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code OSI·July 1, 2013

    MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 RM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code HSX·March 8, 2024

    BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020