17 results
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30ms
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Sources: EU EUDAMED, US FDA
MANUAL WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
Reicodent
FDA UDI
devemed GmbH·04061644053940·Osteotome-Attachment "Palti"
bayonet, concave; ...
Reicodent
FDA UDI
devemed GmbH·04061644053933·Osteotome-Attachment "Palti"
bayonet, concave; ...
Reicodent
FDA UDI
devemed GmbH·04061644053919·Osteotome-Attachment "Palti"
bayonet, concave; ...
Reicodent
FDA UDI
devemed GmbH·04061644053926·Osteotome-Attachment "Palti"
bayonet, concave; ...
Reicodent
FDA UDI
devemed GmbH·04061644053957·Osteotome-Attachment "Palti"
bayonet, concave; ...
HEARTTRENDS
FDA 510(k)
FDA Class 2
·Cardiovascular
KING OF HEARTS EXPRESS + AF MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·March 27, 2013
MEDISENSE OPTIUM
FDA Adverse Event
Malfunction
·Product code NBW·March 17, 2011
ACCU-CHEK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 28, 2008
BD ULTRA FINE PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·September 17, 2020
PEN NDL 32G 4MM 100BX 1200 USA
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·January 28, 2021
EVOLUT PRO PLUS VALVE
FDA Adverse Event
Injury
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·July 21, 2025
PEN NDL 32G 4MM 100BX 1200 USA
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FRN·November 24, 2020
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