BEUDAMED
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    16PW - Washington Gas - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588014425·16PW - Washington Gas - Poly White

    Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113455·SUPER SHARPS 15 DEG 5MM (BX/5)

    ESU HANDSWITCHING PENCIL

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

    OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & RESERVOIR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    UNK LATARJET SCREW

    FDA Adverse Event
    Injury ·DEPUY MITEK·Product code HWC·June 14, 2017

    UNK LATARJET SCREW

    FDA Adverse Event
    Injury ·DEPUY MITEK·Product code HWC·June 14, 2017

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 27, 2014

    STENOSCOP

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 26, 2013

    HS III PROXIMAL SEAL SYSTEM 4.3MM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·August 4, 2011

    ESSURE

    FDA Adverse Event
    Injury ·BAYER HEALTHCARE LLC·Product code HHS·August 25, 2016

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code ODP·April 1, 2019

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code ODP·April 1, 2019

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code ODP·April 1, 2019

    Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).

    FDA Enforcement
    Class II ·Completed·Mako Surgical Corporation·November 25, 2020

    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