BEUDAMED
    22 results · 23ms · 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 ×

    MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra

    FDA 510(k)
    FDA Class 2 ·Radiology

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526550148·GENUMEDI PT KNEE SUP SILVER L EW V

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707011378·CALIBRA 1ST MOL BANDS W/G8025-02 n.UR 15

    IV Administration Set

    FDA UDI
    B. BRAUN MEDICAL INC.·04046964188299·Primary Gravity IV Set, 0 Injection Sites

    3DP Lumbar Interbody System

    FDA UDI
    Genesys Orthopedics Systems LLC·M719GL3DM1425150·Medium 15-Degree 3DP LLIF - 14mm x 25mm

    Apache

    FDA UDI
    Genesys Orthopedics Systems LLC·M719GLLTIM1425150·Medium 15 DEG Titanium LLIF

    Apache

    FDA UDI
    Genesys Orthopedics Systems LLC·M719GLLTIL1425150·Large 15 DEG Titanium LLIF

    NP15

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PENCAN®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code BSP·May 6, 2025

    TPRLC 133 MP TYPE1 PPS SO 16.0

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LZO·January 30, 2025

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 6, 2014

    PELVICOL ACELLULAR COLLAGEN MATRIX

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABORATORIES·Product code FTL·April 24, 2013

    ENDOPATH STEALTH CIR STAPLER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code KOG·June 28, 2011

    PENCAN®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code BSP·April 10, 2025

    TPRLC 133 T1 PPS HO 15X150MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LZO·January 30, 2025

    TPRLC 133 T1 PPS SO 16X152MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LZO·January 30, 2025

    da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015