13 results · 27ms · Sources: EU EUDAMED, US FDA

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MACROPORE OS TRAUMA

FDA 510(k)
FDA Class 2 ·Orthopedic

ULTRAPOWER

FDA UDI
Conmed Corporation·10845854001653·ULTRAPOWER BUR, ROUND DIAMOND (COPPER), 4 MM

Reicodent

FDA UDI
devemed GmbH·04061644063024·Operating scissors 14 cm "Joseph" REGULAR CUT c...

Reicodent

FDA UDI
devemed GmbH·04061644062942·Operating scissors 14 cm "Joseph" SUPER CUT curved

MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

'RAPIDONE'-METHADONE TEST

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·March 26, 2013

ENTRUST AT

FDA Adverse Event
Death ·MEDTRONIC MED REL, INC.·Product code LWS·March 16, 2011

EAGLE 4000

FDA Adverse Event
Malfunction ·GE HEALTHCARE·Product code MHX·March 20, 2008

BLAKE DRAIN UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GBX·July 30, 2024

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

FDA Enforcement
Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

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