BEUDAMED
    17 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 ×

    IMMULITE 2000 FREE T4

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OASIS MEDICAL, INC.

    FDA registration
    OASIS MEDICAL, INC.·17 products·🇺🇸 United States

    Caplugs/Evergreen

    FDA UDI
    CAPlugs·00810044206883·EXTRACTION COLUMN NO FILTER

    Oasis Medical, Inc.

    FDA registration
    Oasis Medical, Inc.·16 products·🇺🇸 United States

    FORM FIT HYDROGEL CANALICULAR PLUGS

    FDA Adverse Event
    Other ·OASIS MEDICAL, INC.·Product code LZU·December 5, 2008

    PROCAD ADD-ON

    FDA 510(k)
    FDA Class 2 ·Dental

    OMNI C ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    WAVEWRITER ALPHA PRIME 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 14, 2022

    FORM FIT HYDROGEL CANALICULAR PLUG

    FDA Adverse Event
    Other ·OASIS MEDICAL, INC.·Product code LZU·September 11, 2009

    FORM FIT HYDROGEL CANALICULAR PLUG

    FDA Adverse Event
    Other ·OASIS MEDICAL, INC.·Product code LZU·September 11, 2009

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 29, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 10, 2011

    COBAS INTEGRA 400 PLUS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·July 28, 2008

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 18, 2025

    IMPACT Catheters, Balloon Dilatation and Esophageal Dilatation Catheter, Model Number 307, STERILE, Rx only --- Common/Usual Name: PTA and Esophageal Catheter --- Manufactured for: B. Braun Interventional Systems Inc., 824 Twelfth Avenue Bethlehem, PA18018 --- Manufactured by: NuMED, Inc. 2880 Main Street, Hopkinton, NY 12965 --- The Impact catheter is packaged in a straight sheath and then heat sealed in two Tyvek pouches. The inner pouch is the one that is deteriorating when exposed to the sunlight. The outer pouch retains its seal so the sterility is not compromised. --- 510 K931009 - Device Listing #D003206 and 510 K983373 - Device Listing # D003212, Class II device.

    FDA Recall
    Terminated ·Numed Inc·Product code LIT·September 23, 2009

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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