BEUDAMED
    23 results · 22ms · 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 ×

    ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    drive

    FDA UDI
    Drive Devilbiss Healthcare·50822383729133·Bath Safety Grab bars Product Description GrabB...

    Drive

    FDA UDI
    Drive Devilbiss Healthcare·00822383729138·GrabBar,16",White,3/cs,RTL

    PMT® CORPORATION HALO

    FDA UDI
    PMT CORPORATION·00650551044963·SURGICAL BED ADAPTER, POSTERIOR

    Diversatek Healthcare

    FDA UDI
    DIVERSATEK HEALTHCARE, INC.·M7831201630·Endoscopy Basic Procedure Kit w/ Combination En...

    DRIVEMEDICAL

    FDA UDI
    Drive Devilbiss Healthcare·00612479224254·Bath SafetyGrab Bars Product Description: GrabB...

    NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX

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

    REALSEAL XT SEALER

    FDA 510(k)
    FDA Class 2 ·Dental

    T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·April 13, 2020

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 14, 2023

    T:SLIM G5 SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OYC·October 24, 2018

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 16, 2023

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 28, 2014

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 20, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·June 6, 2011

    ACCU-CHEK SPIRIT CARTRIDGE

    FDA Adverse Event
    Malfunction ·DISETRONIC MEDICAL SYSTEMS·Product code LZG·August 14, 2008

    RESONANCE STENT SET

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FAD·March 3, 2020

    Merit Medical Surgical Convenience Kits, Custom and SPPT, Merit Medical, South Jordan, UT 84065. Part numbers: K05-01767A, K05-01769, K05-01769A, K09-03843M, K09-03951M, K09-05894F, K09-08610, K10-00033Q, K10-00382M, K10-00685K, K10-00984F, K10-01531F, K10-01826D, K10-01826F, K10-02902B, K10-03080D, K10-03378C, K10-03397B, K10-03590A, K10-03590B, K10-03659D, K10-03659F, K10-03659G, K10-03689, K10-03907B, K12-01342D, K12-01444B, K12-01468, K12-01484A, K12-01487, K12-01490A, K12-01593, K12-01638, K12-01661, K12-01667, K12-01667A, K12-01964, K12-01968, K12-02098, SPPT-100/C, SPPT-5F-10C, SPPT-5F-10L/A, SPPT-5F-7/C, SPPT-5F-7L/A.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc·Product code LRO·August 15, 2007

    MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software

    FDA Enforcement
    Class II ·Ongoing·Auris Health, Inc·February 25, 2026

    Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.

    FDA Enforcement
    Class II ·Ongoing·AURIS HEALTH INC·October 16, 2024