BEUDAMED
    19 results · 22ms · 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 ×

    HRK-123 KNEE ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306800542·Baby Iris Scissors, Curved, 9cm

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450140994·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450311462·

    KINETRA

    FDA Adverse Event
    Death ·MDT PUERTO RICO OPERATIONS CO·Product code MHY·July 3, 2012

    DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TEMPTELLER INFARED EAR THERMOMETERS, MODEL CT-31/31DX/32/32DX

    FDA 510(k)
    FDA Class 2 ·General Hospital

    KINETRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·November 26, 2013

    SOLETRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code MHY·July 12, 2012

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·April 30, 2012

    SOLETRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code MHY·April 30, 2012

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 12, 2012

    HORIZON APPLIER SMALL 8" CVD

    FDA Adverse Event
    Malfunction ·TELEFLEX·Product code GDO·April 8, 2013

    ACCU-CHEK TENDER

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS·Product code FPA·May 22, 2008

    ENDOTAK DSP

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·April 12, 2011

    ISODUR PROSTHESIS HEAD 12/14 32MM XL

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO KG·Product code LPH·March 28, 2014

    WINCH KYPHOPLASTY KIT 15MM

    FDA Adverse Event
    Malfunction ·G21 S.R.L.·Product code NDN·June 21, 2024

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014