BEUDAMED
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    OLEA SPHERE

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARGELITE 49 (5 dwt)

    FDA UDI
    ARGEN CORPORATION, THE·D818120196·Alloy other noble metal

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319703670·Gruenwald (Jansen) Dressing Forceps 8-1/2" (21c...

    Diversatek Healthcare

    FDA UDI
    DIVERSATEK HEALTHCARE, INC.·M7831201960·Basic Endoscopy Procedure Kit

    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

    COMPUTED TOMOGRAPHY X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    T:SLIM G5 SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OYC·December 11, 2020

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·June 24, 2019

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·August 8, 2022

    GALAXY G3 XSFT HEL 2MM X 8CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·July 29, 2020

    BD VACUTAINER MULTIPLE SAMPLE LUER ADAPTER

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·February 3, 2021

    1.5X4MM RAPIDFIRE SCREWS,5PK

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HWC·May 20, 2013

    PULSE GEN MODEL 103

    FDA Adverse Event
    Injury ·CYBERONICS INC·Product code LYJ·September 25, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·June 6, 2011

    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

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015