BEUDAMED
    19 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.

    ZMATCH BLOCK

    FDA 510(k)
    FDA Class 2 ·Dental

    Harvard Restore A1

    FDA UDI
    Harvard Dental International GmbH·EHAR70832011·Light cure universal microhybrid composite

    Orthopedic manual surgical instrument

    FDA UDI
    BAUI BIOTECH CO. LTD.·04712899253172·Rod Template

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450419892·

    NaturaLyte

    FDA UDI
    Fresenius Medical Care Renal Therapies Group, LLC·00840861101726·NaturaLyte Liquid Acid Concentrate for Bicarbon...

    CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    STEALTHSTATION TREATMENT GUIDANCE PLATFORM

    FDA 510(k)
    FDA Class 2 ·Neurology

    SINAI HSP BALTIMORE MD 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·July 6, 2011

    LAKELAND REG LAKELAND FL 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DWF·May 3, 2010

    WA ADVENT TAKOMA PARK MD 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·November 22, 2011

    IOWA METH DES MOINES IA1

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA, INC.·Product code DTZ·March 7, 2011

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 29, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 11, 2014

    MP70 INTELLIVUE PATIENT MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code DSI·April 13, 2011

    CHLORAPREP ONE STEP HI LITE ORANGE

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code KXF·August 30, 2020

    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3201-4 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·January 20, 2021

    PINNACLE MTL INS NEUT36IDX54OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LZO·September 6, 2012

    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3201-4 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 7, 2020

    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