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

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    KYPHX HV-R, MODEL C01A

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Injury ·KYPHON, INC.·Product code NDN·June 23, 2006

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Injury ·KYPHON, INC.·Product code NDN·June 20, 2006

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033801·Baltic Denture System BDLoad BDLoad ↓ Sw7 PLSEu...

    Phonak

    FDA UDI
    Phonak AG·07613275359402·Phonak Sky V30-UP (beige)

    K133801

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 31, 2024

    SPACELABS HEALTHCARE

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522121869·PATIENT CABLE,STANDARD STRESS,PM-3,EU

    ANATOMICAL PRESS-FIT HUMERAL STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ULTRASAFE DENTAL INJECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 3, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED REL·Product code MDS·March 17, 2011

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·April 24, 2008

    SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 42-15

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HSD·June 26, 2018

    RADIESSE DERMAL FILLER

    FDA Adverse Event
    Other ·MERZ NORTH AMERICA, INC.·Product code LMH·October 4, 2013

    SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 50-21

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HSD·June 11, 2018

    Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412; TREVO NXT 4X28+TRAK21 2-PACK - CE, REF: 91413; TREVO NXT 4X41+TRAK21 2-PACK - CE, REF: 91414; TREVO NXT 6X37+TRAK21 2-PACK - CE, REF: 91415; TREVO NXT 4X28+TRAK21+CAT6 3-PACK - CE, REF: SFP914170 TREVO NXT 6X37+TRAK21+CAT6 3-PACK - CE, REF: SFP914190. Used in the placement of devices and/or fluids, such as contrast media, into the peripheral, coronary, and neuro vasculature during diagnostic and/or therapeutic procedures.

    FDA Enforcement
    Class II ·Ongoing·Stryker Neurovascular·July 27, 2022

    Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number CC3217 (Reorder No. 21-0338-01) Speciality Administration Checkvalve Filter Set has 107 inch length/272 cm, 27.5ml priming volume, 20 drops/ml, 2 SureSite Prepierced Injection Sites and 0.22 micron air-eliminating filter.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024