BEUDAMED
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    PERFRINGENS SUPPLEMENT B

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Preat Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092174647·1.8mm Retention Caps--Green (6-Pack)

    ARROW

    FDA UDI
    TELEFLEX INCORPORATED·10801902140873·Pediatric Two-Lumen Central Venous Catheterizat...

    ACUMED

    FDA UDI
    Acumed LLC·10806378040733·Anatomic Midshaft Forearm Screw Cad Assy

    GO MEDICAL BALLOON INFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

    FDA Adverse Event
    Injury ·HOLOGIC·Product code HIH·May 1, 2014

    LIGACLIP EXTRA TITANIUM CLIPS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·October 22, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 31, 2007

    HeartStart FR2+ automated external defibrillator (AED) model: M3841: LAERDAL brand; text prompts only on screen (NO ECG); no configurable manual charge.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code MKJ·May 28, 2010

    HeartStart FR2+ automated external defibrillator (AED) Model M3860: Philips brand; configurable ECG on screen; configurable manual charge in advance mode.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code MKJ·May 28, 2010

    HeartStart FR2+ automated external defibrillator (AED) model: M3861: PHILIPS brand; text prompts only on screen (NO ECG); no configurable manual charge.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code MKJ·May 28, 2010

    HeartStart FR2+ automated external defibrillator (AED) model: M3840: LAERDAL brand; configurable ECG on screen; configurable manual charge in advance mode.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code MKJ·May 28, 2010

    HeartStart FR2+ AED with ECG Display, Model 3840, Laerdal brand, configurable manual charge in advance mode. The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manufactured by: Philips Medical Systems Seattle, WA 98121".

    FDA Recall
    Terminated ·Philips Medical Systems·Product code MKJ·September 22, 2010

    HeartStart FR2+ AED with Text Display (No ECG), Model M3861, Philips brand, no configurable manual charge. The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manufactured by: Philips Medical Systems Seattle, WA 98121".

    FDA Recall
    Terminated ·Philips Medical Systems·Product code MKJ·September 22, 2010

    HeartStart FR2+ AED with Text Display (No ECG), Model 3841, Laerdal brand, no configurable manual charge. The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manufactured by: Philips Medical Systems Seattle, WA 98121".

    FDA Recall
    Terminated ·Philips Medical Systems·Product code MKJ·September 22, 2010

    Automated External Defibrillator(AED) of brand name "Philips HeartStart HS1 OnSite" (Model number M5066A). Device is designed for use on a person in sudden cardiac arrest who is unresponsive when shaken and not breathing normally

    FDA Recall
    Terminated ·Philips Medical Systems·Product code MKJ·April 30, 2010

    Automated External Defibrillator (AED) of brand name "Philips HeartStart HS1 Home" (Model Number M5068A). Device is designed for use on a person in sudden cardiac arrest who is unresponsive when shaken and not breathing normally

    FDA Recall
    Terminated ·Philips Medical Systems·Product code MKJ·April 30, 2010

    Automated External Defibrillator (AED) of brand name "Philips HeartStart FRx" (Model number 861304). Device is designed for use on a person in sudden cardiac arrest who is unresponsive when shaken and not breathing normally

    FDA Recall
    Terminated ·Philips Medical Systems·Product code MKJ·April 30, 2010

    HeartStart FR2+ AED with ECG Display, Model M3860, Philips brand, configurable manual charge in advance mode. The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manufactured by: Philips Medical Systems Seattle, WA 98121".

    FDA Recall
    Terminated ·Philips Medical Systems·Product code MKJ·September 22, 2010