BEUDAMED
    16 results · 21ms · 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 ×

    NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE

    FDA 510(k)
    FDA Class 2 ·Dental

    Disposable Kit, Sterile and Non Sterile, iX

    FDA UDI
    RESTORATION ROBOTICS, INC.·00850470007579·

    PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MACROPORE ENT RECONSTRUCTION FILM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SP2 IM ROD 400MM

    FDA Adverse Event
    Malfunction ·DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS·Product code LXH·May 9, 2013

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 19, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 23, 2011

    MICRUSFRAME18 7MM X 14.3CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·June 29, 2022

    MICRUSFRAME10 7MM X 30CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·June 29, 2022

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    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

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·March 4, 2015