10 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB
FDA 510(k)
FDA Class 3
·Cardiovascular
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120206691·Carbide, cylinder round, excavating and fissure...
MEDIVISION I-VIEW PERSONAL VIDEO DISPLAY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EZ-LIGHT 4000 SERIES MANUAL WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 28, 2018
PINNACLE SECTOR ACETABULAR CUP W/DUGFIX HA, 52MM 50
FDA Adverse Event
DEPUY·Product code KWA·March 18, 2013
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·March 4, 2011
SYMPHONY
FDA Adverse Event
Injury
·ELA MEDICAL, S.A.S.·Product code DXY·March 27, 2008
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