11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ULTRAPOWER
FDA UDI
Conmed Corporation·10845854007709·6MM ULTRAPOWER BUR, ROUND DIAMOND (COPPER)
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450156537·
Reicodent
FDA UDI
devemed GmbH·04061644046522·Gingivectomy-scissors 13 cm "Goldman-Fox"
WOLFR...
MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ULTRA V THERAPEUTIC ULTRASOUND
FDA 510(k)
FDA Class 2
·Physical Medicine
SIGNATURE GLIDE
FDA Adverse Event
Malfunction
·MEDLINE INDUSTRIES INC·Product code KGO·March 21, 2013
SPRINT FIDELIS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 16, 2011
ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code NTE·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