BEUDAMED
    20 results · 24ms · 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 ×

    Pyrenees Cervical Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HHM

    FDA UDI
    Oticon A/S·05707131283351·H100V2, BTE 13 WL 85 CBE HHM

    IRMA TRUPOINT CREATININE CONTROL KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CENTRIMAG DRAINAGE CANNULA KIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    KYPHON HV-R BONE CEMENT

    FDA Adverse Event
    Injury ·MDT KYPHON NEUCHATEL MFG·Product code NDN·October 25, 2017

    KYPHX® HV-R¿ BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·April 7, 2017

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·July 19, 2020

    KYPHX® HV-R¿ BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 4, 2019

    KYPHX® HV-R¿ BONE CEMENT

    FDA Adverse Event
    Injury ·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 17, 2017

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·December 17, 2018

    KYPHX® HV-R¿ BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 7, 2017

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·October 12, 2017

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·July 9, 2020

    ADAPTER SLEEVE 11/13 +9

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·June 6, 2013

    ULTRACISION HARMONIC SCALPEL CURVED SHEARS, SCISSOR-GRIP HANDLE - 14 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GEI·August 28, 2008

    AUGMENTED INSERT

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.·Product code KWA·June 29, 2011

    TORNIER PERFORM ANATOMIC AUG MED RIGHT GLENOID 15 DG

    FDA Adverse Event
    Injury ·TORNIER INC·Product code KWS·March 8, 2024

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF: 1005611; Pump, t:slim X2, Control-IQ, mmoUL, Refurbished Replacement, REF: 1005613; Pump, t:slim X2, Control-IQ, mg/dl, REF: 1005615; Pump, t:slim X2, Control-IQ, mg/dl, Refurbished Replacement, REF: 1005617; Pump, t:slim X2, Basal-IQ 6.4, Refurbished Replacement, REF: 1006379; Pump, t:slim X2, Control-IQ 7.4, REF: 1006402; Pump, t:slim X2, Control-IQ 7.4, Replacement, REF: 1006406; Pump, t:slim X2, Control-IQ 7.4, REF: 1006408; Pump, t:slim X2, Basal-IQ, , REF: 1006419; Pump, t:slim X2, Basal-IQ, mg/dL, REF: 1006420; Pump, t:slim X2, Basal-IQ, mmoUL, Refurbished Replacement, REF: 1006535; Pump, t:slim X2, Basal-IQ, mg/dL, Refurbished Replacement, REF: 1006537; Pump, t:slim X2, Control-IQ, mg/dl , Replacement, REF: 1008255; Pump, t:slim X2, Control-IQ, mmoUL, Replacement, REF: 1008256; Pump, t:slim X2, Basal-IQ, mmoUL, Replacement, REF: 1008257; Pump, t:slim X2, Basal-IQ, mg/dl ,Replacement, REF: 1008258; Pump, t:slim X2, Basal-IQ, REF: 1010004; Pump, t:slim X2, Basal-IQ, Replacement, REF: 1010005; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010006; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010007; Pump, t:slim X2, Control-IQ, REF: 1010009; Pump, t:slim X2, Control-IQ Replacement, REF: 1010010; Pump, t:slim X2, Control-IQ, Medicare, REF: 1010011; Pump, t:slim X2, Control-IQ, Refurbished Replacement, REF: 1010012; Pump, t:slim X2, Control-IQ, REF: 1012867; Pump, t:slim X2, Control-IQ, Medicare, REF: 1012868; Pump, t:slim X2, Control-IQ, Replacement, REF: 1012869; Pump, t:slim X2, Control-IQ 7.8, REF: 1013195; Pump, t:slim X2, Control-IQ 7.8, Medicare, REF: 1013196; Pump, t :slim X2, Control-IQ 7.8, Replacement, REF: 1013197; Pump, t:slim X2, Control-IQ 7.8, Refurbished Replacement, REF: 1013198

    FDA Enforcement
    Class I ·Ongoing·Tandem Diabetes Care, Inc.·September 3, 2025