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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CODMAN HAKIM SHUNT SYSTEMS
FDA 510(k)
FDA Class 2
·Neurology
OrthAlign Plus
FDA UDI
Orthalign, Inc.·00810832031413·LSA Knee Tray Base
MAST GROUP LTD.
FDA registration
MAST GROUP LTD.·10 products·🇬🇧 United Kingdom
GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER LABEL CLAIM
FDA 510(k)
FDA Class 1
·General Hospital
DEPUY ASR XL FEM IMP SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·June 11, 2014
3.7MM TI CERVICAL SPINE SCREW SLF-TPNG/VARIABLE ANGLE 14MM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code OVE·March 26, 2013
CERNER MILLENNIUM PHARMNET INPATIENT
FDA Adverse Event
Injury
·CERNER CORP.·Product code LNX·March 7, 2011
ASCENSIA BREEZE2
FDA Adverse Event
Injury
·BAYER HEALTHCARE, LLC·Product code NBW·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