BEUDAMED
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    KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MiniKut

    FDA UDI
    DENTAL ENGINEERING LABORATORIES, LLC·00850001745260·MiniKut Rotary NiTi Endodontic Files .30/.03, 2...

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091033021·Baltic Denture System BDLoad ↓ Sw7 PLSEum6DFs C...

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0430210·Sagittal Bender, Double Ended Right

    MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LIGHTLANCE LASER SKIN PERFORATOR

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

    NA

    FDA UDI
    Zimmer, Inc.·00889024114203·

    SINAI HSP BALTIMORE MD 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·July 6, 2011

    LAKELAND REG LAKELAND FL 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DWF·May 3, 2010

    WA ADVENT TAKOMA PARK MD 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·November 22, 2011

    IOWA METH DES MOINES IA1

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA, INC.·Product code DTZ·March 7, 2011

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 3, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·August 25, 2014

    DIMENSION CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code MMI·April 22, 2008

    TIBIA CEMENTED 5 DEGREE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 5, 2019

    NAIL, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code JDS·July 25, 2016

    NAIL, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code JDS·July 25, 2016

    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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021