BEUDAMED
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    SHARP BRAND ACUPUNCTURE NEEDLES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743755·ACHIMED ACHILLES SUPP SAND VI

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526785052·EPICOMED ELB SUPPORT SAND VI

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743632·LEVAMED ANKLE SUPPORT SAND VI

    BARCOMED 5MP2

    FDA 510(k)
    FDA Class 2 ·Radiology

    QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·May 25, 2017

    TECNIS SIMPLICITY

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code HQL·March 31, 2025

    13.0MM FLEXIBLE CANNULATED DRILL BIT LARGE QC/465MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HTW·March 12, 2013

    EONC CONVENTIONAL IPG

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION DIV.·Product code LGW·February 17, 2011

    EMBRACE PUMP

    FDA Adverse Event
    Malfunction ·ROSS PRODUCTS DIVISION·Product code LZH·February 18, 2008

    LUMIRADX SARS-COV-2 AG TEST STRIP KIT

    FDA Adverse Event
    Malfunction ·LUMIRADX UK LTD.·Product code QKP·April 20, 2022

    LUMIRADX SARS-COV-2 AG TEST STRIP KIT

    FDA Adverse Event
    Malfunction ·LUMIRADX UK LTD.·Product code QKP·April 20, 2022

    LUMIRADX SARS-COV-2 AG TEST STRIP KIT

    FDA Adverse Event
    Malfunction ·LUMIRADX UK LTD.·Product code QKP·April 20, 2022

    LUMIRADX SARS-COV-2 AG TEST STRIP KIT

    FDA Adverse Event
    Malfunction ·LUMIRADX UK LTD.·Product code QKP·April 20, 2022

    LUMIRADX SARS-COV-2 AG TEST STRIP KIT

    FDA Adverse Event
    Malfunction ·LUMIRADX UK LTD.·Product code QKP·April 20, 2022

    DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code NAD·November 18, 2020

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

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

    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

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016