BEUDAMED
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    UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VANGUARD PFR FEMORAL LT SM

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code KRR·May 17, 2018

    PowerPICC SOLO

    FDA UDI
    Bard Access Systems, Inc.·00801741152610·Catheter Placement Kit

    TruLock

    FDA UDI
    Rmo, Inc.·00885797644930·TRULOCK Primer Activated Adhesive Kit (40 Capsule)

    AtriClip® PRO Gillinov-Cosgrove LAA Exclusion System

    FDA UDI
    ATRICURE, INC.·10840143912054·LAA Exclusion System, PRO150

    AtriClip™ LAA Exclusion System

    FDA UDI
    ATRICURE, INC.·00818354011845·AtriClip® PRO Gillinov-Cosgrove LAA Exclusion S...

    AtriClip™ LAA Exclusion System

    FDA UDI
    ATRICURE, INC.·10840143901409·AtriClip® PRO Gillinov-Cosgrove LAA Exclusion S...

    AtriClip™ LAA Exclusion System

    FDA UDI
    ATRICURE, INC.·10840143907210·AtriClip® PRO Gillinov-Cosgrove LAA Exclusion S...

    Cable

    FDA UDI
    Zoll Medical Corporation·00847946021856·VPAK, CABLE, PATIENT, X SERIES

    INSUFFLATION NEEDLE, MODEL R65-933

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    AUTOSOFT 90

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 15, 2024

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code NIQ·May 3, 2006

    OT VERIO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 13, 2013

    AKREOS POSTERIOR CHAMBER IOL

    FDA Adverse Event
    Injury ·BAUSCH & LOMB·Product code HQL·February 17, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·February 19, 2008

    Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.

    FDA Enforcement
    Class II ·Terminated·Myolyn Inc.·August 24, 2022

    qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs 4.1 kg (10.3 inches x 12.4 inches x 5.2 inches - 9 lbs). It has a 26.2 cm (12.1 inches) LCD display with 1024 x 768 resolution. The Spacelabs Healthcare Qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by 2 Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECU, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed. The Qube is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. The Qube may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow network-based applications to open windows and display information on other networked monitors. The Qube is also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. The Qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·November 28, 2012

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018