BEUDAMED
    22 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 ×

    SkinPen Precision Elite System

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

    SpheRx

    FDA UDI
    Nuvasive, Inc.·00887517444325·SpheRx® II Conn, 40mm Transverse Fixed

    Integra® Miltex®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780160120·Integra® Miltex® DeBakey Aortic Aneurysm Clamp,...

    Spud

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101223·ELLIS FOREIGN BODY SPUD

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702818611·ELVAREX 3/KNEE HIGH/SLANT-CLOSED TOE-ELEPHANTIA...

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702782448·ELVAREX 2/KNEE HIGH/CLOSED TOE/DOTTED SILICONE ...

    DCCERAM SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    FORTIFIER DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LF-01

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·July 7, 2021

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    MEDTRONIC

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code LDF·November 10, 2014

    MACH1 GUIDE CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·July 22, 2013

    MICROPLASTY TIBIAL TRAYS

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·March 21, 2017

    VANGUARD 360 REVISION KNEE SYSTEM - FEMORAL FLAT AUGMENTS

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·March 21, 2017

    BIOMET TIBIAL TRAYS

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·March 21, 2017

    VANGUARD 360 REVISION KNEE SYSTEM - FEMORAL FLAT AUGMENT 70X10

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·March 21, 2017

    VANGUARD PATELLA COMPONENTS

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·March 21, 2017

    VANGUARD COMPLETE KNEE SYSTEM - FEMORAL

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·March 21, 2017

    Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 40-0137-S 3.0mm x 90mm Dual-Trak Clavicle Screw 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 40-0138-S 3.0mm x 100mm Dual-Trak Clavicle Screw 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 40-0139-S 3.0mm x 110mm Dual-Trak Clavicle Screw 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 40-0140-S 3.0mm x 120mm Dual-Trak Clavicle Screw 40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw 40-0143-S 3.8mm x 80mm Dual-Trak Clavicle Screw 40-0144 3.8mm x 90mm Dual-Trak Clavicle Screw 40-0144-S 3.8mm x 90mm Dual-Trak Clavicle Screw 40-0145 3.8mm x 100mm Dual-Trak Clavicle Screw 40-0145-S 3.8mm x 100mm Dual-Trak Clavicle Screw 40-0146 3.8mm x 110mm Dual-Trak Clavicle Screw 40-0146-S 3.8mm x 110mm Dual-Trak Clavicle Screw 40-0147 3.8mm x 120mm Dual-Trak Clavicle Screw 40-0147-S 3.8mm x 120mm Dual-Trak Clavicle Screw

    FDA Enforcement
    Class II ·Ongoing·Acumed LLC·January 4, 2023

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020