BEUDAMED
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    miraDry System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MAESTRO TOTAL WRIST

    FDA UDI
    Biomet Orthopedics, LLC·00880304479432·

    Maestro™ Total Wrist

    FDA UDI
    Biomet Orthopedics, LLC·00887868239878·

    BYTE DAY ALIGNERS

    FDA Adverse Event
    Malfunction ·STRAIGHT SMILE, LLC·Product code NXC·October 31, 2024

    ASPIRA PERITONEAL DRAINAGE SYSTEM

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

    OSSEOSPEED NARROW

    FDA 510(k)
    FDA Class 2 ·Dental

    T:SLIM X2, BASAL-IQ, MMOL/L

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·August 19, 2020

    REAMER SHAFT, MOD. TRINKLE BIXCUT 8.0 X 284 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·December 18, 2012

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·August 4, 2023

    PINNACLE PELVIC FLOOR REPAIR KITS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013

    HEARTMATE XVE

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·July 27, 2011

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 17, 2014

    HEPARIN LOCK FLUSH SOLUTION, USP

    FDA Adverse Event
    Malfunction ·AMERICAN PHARMACEUTICAL PARTNERS, INC.·Product code ---·July 11, 2001

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

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

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

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

    30K FSI-SLI-FG-10L INS,PKD

    FDA Adverse Event
    Malfunction ·DENTSPLY LLC·Product code ELC·August 15, 2023

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014