12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NIKOMED TRACE 1 ECG ELECTRODES
FDA 510(k)
FDA Class 2
·Cardiovascular
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496022909·WONDER MODEL 70, SIZE M BRONZE, GRADUATED COMPR...
Cardiovascular Procedure Kit
FDA UDI
Terumo Cardiovascular Systems Corporation·50699753483601·
ORTHO SUMMIT SAMPLE HANDLER
FDA Adverse Event
Malfunction
·HAMILTON BONADUZ AG·Product code JTC·August 18, 1999
XTERRA GT POWER WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
ACRYDERM SILVER ANTIMICROBIAL STRANDS MODEL A-020103
FDA 510(k)
FDA Unclassified
·Unknown
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·March 27, 2013
X-SMART
FDA Adverse Event
Malfunction
·DENTSPLY MAILLEFER·Product code LQY·February 16, 2011
EMBRACE PUMP
FDA Adverse Event
Malfunction
·ROSS PRODUCTS DIVISION·Product code LZH·March 28, 2008
BD ALARIS¿ SMARTSITE¿ EXTENSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 23, 2023
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