BEUDAMED
    16 results · 29ms · 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 ×

    MULTI-ANALYTE CHEMISTRY CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108694024·Step Drill Stop for L6mm Implant, Wide Long

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108697643·Titanium Base Abutment Round, Int. Hex. SP L4mm...

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0102070·Shaver, Open 7mm

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023901·PADDLE SPREADER, 7MM

    POROCOAT PRODIGY HIP PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PORTABLE INSTENSIVE CARE UNIT

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    X-STOP IPD SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SPINE LLC·Product code NQO·December 31, 2009

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·April 22, 2013

    SARNS

    FDA Adverse Event
    TERUMO MEDICAL CORPORATION·Product code DTQ·June 27, 2008

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·April 18, 2011

    OLYMPUS ESG-100, 100...120 V~,

    FDA Adverse Event
    Injury ·OLYMPUS WINTER & IBE GMBH·Product code GEI·September 27, 2022

    PRODIGY LG STAT SHT LT 12.0MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·February 2, 2016

    PRODIGY LG STAT LNG LT 13.5MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·June 3, 2018

    Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015