BEUDAMED
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    BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SCANLAN® Legacy Micro Forceps

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159032987·Legacy FRCP FH 1MM DEB T 9"

    SCANLAN®

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159032321·SCANLAN® Legacy Forceps Debakey Tips

    PF1 6-18MM Handpiece Delivery System W/DCD

    FDA UDI
    Candela Corporation·00817495021232·Delivery System Assembly

    SILASTIC MAMMARY IMPLANT, 150 CC

    FDA Adverse Event
    DOW CORNING CORP.·Product code FTR·November 2, 1994

    TRIDENT ALL POLY CUP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESTORE

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 14, 2013

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·March 1, 2011

    DAVOL

    FDA Adverse Event
    Injury ·DAVOL FIELD ASSURANCE·Product code GDW·February 25, 2008

    Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules. In all applications, Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwire or wireless transmission. Through this network, a patient's data may be displayed at the bedside monitor, central station or clinical information system.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·September 26, 2012

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024