BEUDAMED
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    Sonio Detect

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ultra-Care Insulin Syringe 31G 5/16" 1 CC 100 Ct

    FDA UDI
    ARISE MEDICAL LLC·00372217007081·Ultra-Care Insulin Syringe 31G 5/16" 1 CC 100 Ct

    NA

    FDA UDI
    SYNTHES (U.S.A.) LP·10886982165039·L-BUTTRESS PLATE/6 HOLES/117MM ANGLED LEFT FOR ...

    ENDOSCOPE REPROCESSOR

    FDA Adverse Event
    Malfunction ·AIZU OLYMPUS CO., LTD.·Product code FEB·April 29, 2024

    DESTINO TWIST, STEERABLE GUIDING SHEATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POLYMER COATED, CHLORINATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 11.5MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·May 3, 2021

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 25, 2008

    MERLIN PROGRAMMER

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code KRG·September 9, 2011

    DUROM HIP

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·July 18, 2013

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504 178575 178576 178577 178578 178579 178580 178730 178731 178732 178733 178734 178735 178354S 178754 178755 178756 178757 178758 178759 Product Usage: 1) Correction of revision of unsuccessful osteotomy, arthrodesis or previous joint replacement 2) Tumor resections 3) Revision of previously failed total joint arthroplasty 4) Trauma The ComPreSs Distal Femoral Replacement System is intended for uncemented use.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) 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; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

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