BEUDAMED
    21 results · 28ms · Sources: EU EUDAMED, US FDA

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    Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix

    FDA 510(k)
    FDA Unclassified ·Unknown

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515028043·Farr-Spring Retractor, sharp, 2 1/2"

    LINK Instrument

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575213320·Trial Shell/Insert Adapter

    LINK Instrument

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575213344·Trial Shell/Insert Adapter

    LINK Instrument

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575213306·Trial Shell/Insert Adapter

    LINK Instrument

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575213351·Trial Shell/Insert Adapter

    LINK Instrument

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575213313·Trial Shell/Insert Adapter

    LINK Instrument

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575213337·Trial Shell/Insert Adapter

    FASTTAKE

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·July 31, 2002

    PENUMBRA SYSTEM MAX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OMNI 2 OXYGEN SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    METRIX AIR

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·November 21, 2016

    OT ULTRALINK METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·July 28, 2011

    DEPUY ASR XL FEM IMP SIZE 45

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KXA·June 21, 2013

    BELLUCCI MICRO SCISSORS

    FDA Adverse Event
    Malfunction ·KARL STORZ ENDOSCOPY-AMERICA, INC.·Product code LRW·September 17, 2008

    Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026