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

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    SERRALNYL

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

    Humelock II Cemented Shoulder System

    FDA UDI
    FX SOLUTIONS·03701037305737·K-WIRE CENTER GUIDE Ø46 mm

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717101861·Burs FG 58, Pkg/100

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036019334·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450157381·

    NA

    FDA UDI
    STRYKER CORPORATION·04546540756145·11.5MM TUNNEL DILATOR

    SleepScout

    FDA UDI
    Cleveland Medical Devices Inc.·B143502014610·Wireless portable sleep monitor for sleep testing

    KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY

    FDA 510(k)
    FDA Class 2 ·Radiology

    ENA EIA KIT RANGE

    FDA 510(k)
    FDA Class 2 ·Immunology

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 25, 2007

    PROTEGE EVERFLEX

    FDA Adverse Event
    Injury ·EV3·Product code FGE·March 25, 2013

    ALPHA RESPONSE MATTRESS SYSTEM

    FDA Adverse Event
    Other ·ARJOHUNTLEIGH·Product code FNM·March 9, 2011

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAN·May 19, 2022

    EVIS LUCERA DUODENOVIDEOSCOPE

    FDA Adverse Event
    Death ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDT·December 9, 2021

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAT·September 8, 2021

    NW ABLATION SYSTEM, US

    FDA Adverse Event
    Injury ·NEUWAVE MEDICAL, INC.·Product code NEY·June 25, 2021

    BD LUER-LOK¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·December 22, 2022

    ELUNIR RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDINOL LTD.·Product code NIQ·October 28, 2020

    Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System. BP Ankle System, B-P Type II Talar Ankle Component: Size 1 B-P Type II Talar Ankle Component Catalog: 05-01-0101, Size 2 B-P Type II Talar Ankle Component Catalog: 05-01-0102, Size 3 B-P Type II Talar Ankle Component Catalog: 05-01-0103, Size 4 B-P Type II Talar Ankle Component Catalog: 05-01-0104, Size 5 B-P Type II Talar Ankle Component Catalog: 05-01-0105, Size 6 B-P Type II Talar Ankle Component Catalog: 05-01-0106. BP Ankle System, BP Type II Ankle Bearing: 3x5mm BP Type II Ankle Bearing Catalog: 05-02-0103, 3x6mm BP Type II Ankle Bearing Catalog: 05-02-0113, 3x7mm BP Type II Ankle Bearing Catalog: 05-02-0123, 3x9mm BP Type II Ankle Bearing Catalog: 05-02-0143, 3x11mm BP Type II Ankle Bearing Catalog: 05-02-0163, 3x13mm BP Type II Ankle Bearing Catalog: 05-02-0183, 4x5mm BP Type II Ankle Bearing Catalog: 05-02-0104, 4x6mm BP Type II Ankle Bearing Catalog: 05-02-0114, 4x7mm BP Type II Ankle Bearing Catalog:05-02-0124, 5x5mm BP Type II Ankle Bearing Catalog: 05-02-0105, 5x7mm BP Type II Ankle Bearing Catalog: 05-02-0125, 5x9mm BP Type II Ankle Bearing Catalog: 05-02-0145. 5x6mm BP Type II Ankle Bearing Catalog 05-02-0106. 6x5mm BP Type II Ankle Bearing Catalog 05-02-0115. 6x6mm BP Type II Ankle Bearing Catalog 05-02-0116. 7x6mm BP Type II Ankle Bearing Catalog 05-02-0126. 9x6mm BP Type II Ankle Bearing Catalog 05-02-0146. 11x5mm BP Type II Ankle Bearing Catalog 05-02-0165. 11x6mm BP Type II Ankle Bearing Catalog 05-02-0166. 13x5mm BP Type II Ankle Bearing Catalog 05-02-0185. 13x6mm BP Type II Ankle Bearing Catalog 05-02-0186. BP Ankle System, B-P Type II Tibial Ankle Component Size 1 B-P Type II Tibial ankle Component Catalog: 05-03-0101, Size 2 B-P Type II Tibial ankle Component Catalog: 05-03-0102, Size 3 B-P Type II Tibial ankle Component Catalog: 05-03-0103, Size 4 B-P Type II Tibial ankle Component Catalog: 05-03-0104, Size 5 B-P Type II Tibial ankle Component Catalog: 05-03-0105, Size 6 B-P Type II Tibial ankle Component Catalog: 05-03-0106.

    FDA Recall
    Terminated ·Endotec, Inc.·Product code JWH·June 5, 2009

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012