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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809847819·FOR MEN 15-20 MM HG KNEE HIGH OPEN TOE MEDIUM-L...

    Baby Gorilla®/Gorilla® Plating System

    FDA UDI
    Paragon 28, Inc.·00889795111210·Gorilla R3CON, Drill / Over Drill Guide, Double...

    Baby Gorilla®/Gorilla® Plating System

    FDA UDI
    Paragon 28, Inc.·00889795111227·R3CON, Ø2.7mm Drill sleeve

    MODIFICATION TO XIA SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CALIBRATING MATERIAL, BUFFERS, STANDARD

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    JUGGERKNOT SOFT ANCHORS

    FDA Adverse Event
    Malfunction ·BIOMET ORTHOPEDICS, LLC·Product code MBI·September 30, 2024

    DENALI FEMORAL SYSTEM

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·July 10, 2024

    PTFE FELT PLEDGETS

    FDA Adverse Event
    Injury ·BARD PERIPHERAL VASCULAR, INC.·Product code DXZ·March 4, 2024

    QUIK-COMBO PACING/DEFIBRILLATION/ECG

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL CORP·Product code LDD·March 31, 1998

    BASEPLATE IMPACTOR, ASSEMBLY

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code LXH·January 26, 2024

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 11, 2013

    PICC KIT 2-LUMEN: 5 FR X 19-5/8 (50 CM)

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC·Product code LJS·March 2, 2011

    QUANTUM MAVERICK MR BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·May 21, 2008

    SIZE 10 LEG, GLENOID TARGETER

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code KWS·June 4, 2024

    MINICAP TRANSFER SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·September 5, 2023

    Affixus Hip Fracture Nail, LH 130 DEG 11MM X 260MM

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·February 7, 2018

    Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514A; Bard Silver Lubri-Sil Foley Tray Temperature Sensing with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29000J14, 29030J14, 29000J14S; Bard Silver Lubri-Sil Foley Tray Temperature Sensing, Complete Care with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29030J14S

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·September 3, 2025

    CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·December 27, 2022

    CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·December 27, 2022