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

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    FEMTO LDV Z8 Surgical Laser

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04064984699557·GENUMEDI PSS BLUE SIZE III

    HHM

    FDA UDI
    Oticon A/S·05707131286758·H100V2, MINIRITE 312 WL SIL HHM

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306820014·Marina Dissector, Mini-Langenbeck Tip, Slightly...

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100110·FEASTER SPECULUM SOLID WIDE

    Vertessa Lite Y-Mesh

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

    NAVIGATOR HD URETERAL ACCESS SHEATH SETS

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

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·August 27, 2021

    2027971-2024-150323

    FDA Adverse Event
    Injury ·NOBEL BIOCARE USA, LLC·Product code DZE·November 29, 2024

    FREESTYLE

    FDA Adverse Event
    Malfunction ·THERASENSE INC.·Product code LFR·September 12, 2005

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 12, 2025

    ACCU-CHEK ® INFORM II METER

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code NBW·August 22, 2014

    2520274-2013-03185

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·June 6, 2013

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·June 7, 2011

    9616026-2008-00013

    FDA Adverse Event
    Death ·Product code MQS·September 3, 2008

    PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes L923, L459, L493, L762, L463, L922, L495, L463, L497, L494, L493

    FDA Enforcement
    Class II ·Ongoing·CP Medical Inc·April 26, 2017

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3+ LEFT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 28, 2016

    12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·November 25, 2015