BEUDAMED
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    SNORE GUARD ADVANCE

    FDA 510(k)
    FDA Class 2 ·Dental

    Ackermann

    FDA UDI
    Preat Corporation·00842092107492·Ackermann MD Clip SS

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780178880·Integra® Jarit® Mayo Scissors, 11", Supercut, O...

    Oticon

    FDA UDI
    Oticon A/S·05711584002438·IN1 CIC, BE INIZIA 1

    GEN4 DIGITAL

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828113441·GEN4 DIGITAL

    COVERIS

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030CS1021180·Trial, 13mm x 18mm Lordotic 7, 10mm

    SPIRA®-A Integrated

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030SAZ1021180·SPIRA®-A Integrated,Trial, 28x32mm, 30° Lordoti...

    NIAGARA® Lateral Access System

    FDA UDI
    VB Spine LLC·10888857520097·Straight Blade, Size 30x110 mm

    STOCKERT COMPACT SYSTEM VERSION 2.0

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SCREWDRIVER SHAFT, COMPRESSION T2 TIBIA 3.5 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HXX·July 27, 2012

    NORIAN REINFORCED FAST SET PUTTY/3CC

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code GXP·May 19, 2015

    BD PHASEAL¿ PROTECTOR P55

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·January 10, 2022

    COYOTE? ES

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·May 9, 2013

    STAPLE, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·September 19, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 20, 2011

    Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024