BEUDAMED
    15 results · 19ms · 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.

    POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Altera Filter and HME/Filter

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIOPSYS DRIVERS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code KNW·June 8, 2006

    BIOPSYS DRIVERS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.(CINCINNATIA)·Product code KNW·June 8, 2006

    BIOPSYS DRIVERS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code KNW·June 7, 2006

    E.COM, SYMBIA E

    FDA Adverse Event
    Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code IYX·March 15, 2012

    E.CAM

    FDA Adverse Event
    Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·January 7, 2014

    SYMBIA T-SERIES

    FDA Adverse Event
    Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·September 20, 2013

    E. CAM COMPUTER [510(K) K992731]

    FDA Adverse Event
    Malfunction ·SIEMENS MEDICAL SYSTEMS, INC.·Product code IYX·April 20, 2001

    SAFIL VIOLET 9/0 (0.3) 30CM 2XDLM6S

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL S.A.·Product code GAM·August 7, 2015

    CONFIDENCE INTRODUCER NEEDLE, SIDE HOLE, 13G 4"

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES SPINE·Product code GAA·March 7, 2013

    PROTECTA XT VR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·August 8, 2014

    SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.

    FDA Enforcement
    Class I ·Ongoing·Philips North America Llc·July 3, 2024

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022