BEUDAMED
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    PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065715·INTRAORAL ELASTICS 4,5 oz 5/16" blue

    PENADAPT 10

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

    PALAMED

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.

    FDA Recall
    Terminated ·Natus Medical Incorporated·Product code LBI·November 19, 2014

    OT VERIO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 8, 2013

    INTERSTIM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code EZW·March 23, 2011

    INTRALASE

    FDA Adverse Event
    Injury ·Product code LZS·May 10, 2008

    OTC Pregnancy Test labeled ''CHOICE Pregnancy Test Kit'' (PA-410A), midstream, no cups or droppers. Label reads: ''One Step, Easy to Use, Positive result as early as 1 minute, Over 99% accurate.'' Each box contains one home test kit. Responsible firm on label: Distributed by ICC, Amherst, NY 14228.

    FDA Recall
    Terminated ·International Chemical Inc.·Product code LCX·October 7, 2004

    OTC Pregnancy Test Kit labeled: ''CHOICE Pregnancy Test Kit'' (PA-320) , cassette type with cup and dropper. Label states: ''Easy to Use, Easy Reading, Positive result as early as 1 minute, Over 99% accurate.'' Each box contains one home test kit. Responsible firm on label: Distributed by: ICC, Amherst, NY 14228

    FDA Recall
    Terminated ·International Chemical Inc.·Product code LCX·October 7, 2004

    Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assembly Part Numbers: 001103, 001314, 002110, 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Used to provide treatment for neonatal hyperbilirubinemia

    FDA Recall
    Terminated ·Natus Medical Incorporated·Product code LBI·April 11, 2016

    Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assembly Part Numbers: 001103, 001314, 002110, 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Used to provide treatment for neonatal hyperbilirubinemia

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·June 22, 2016

    Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog Part Number 010066. Top Assembly Part Numbers: 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Device is used to provide treatment for neonatal hyperbilirubinemia.

    FDA Recall
    Terminated ·Natus Medical Incorporated·Product code LBI·April 3, 2017

    Depuy brand ACE trochanteric nail; sterile, long, right hip, 400 x 9 x 130; Product 926209400.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code HSB·December 11, 2003

    Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog Part Number 010066. Top Assembly Part Numbers: 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Device is used to provide treatment for neonatal hyperbilirubinemia.

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·May 10, 2017

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018