13 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NM3 Monitor, English
FDA UDI
Respironics Novametrix, LLC·00884838015593·
POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
DC - CRISTAL
FDA 510(k)
FDA Class 2
·Dental
SEDLINE KIT
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code MWI·December 7, 2017
COCR HEAD, M, 36/0, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code LPH·June 20, 2023
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·April 10, 2013
CRE BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORK LTD.·Product code KOG·May 19, 2008
BIOPORE
FDA Adverse Event
Injury
·GUIDANT ANGLETON/ST. PAUL·Product code NVN·April 12, 2011
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·September 18, 2024
PHILIPS NM3 Monitor Model Number: 7900 PHILIPS NM3 Monitor, English Part Number: 1051674 PHILIPS NM3 Monitor, English, Refurbished Part Number : U1051674 PHILIPS NM3 Monitor, English, Demo Unit Part Number: DU1051674 PHILIPS NM3 Monitor, Spanish Part Number: 1060462 PHILIPS NM3 Monitor, French Part Number: 1060458 PHILIPS NM3 Monitor, Swedish Part Number:1062860 Intended use: Cardiac output monitoring, Spirometric and carbon dioxide monitoring, and Continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate.
FDA Recall
Terminated
·Respironics Novametrix, LLC.·Product code BZK·July 29, 2011
Philips NM3 Monitors, Model 7900 PHILIPS NM3 Monitor, English - P/N 1051674 PHILIPS NM3 Monitor, English Refurbished - P/N U1051674 PHILIPS NM3 Monitor, English, Demo Unit - P/N DU1051674 PHILIPS NM3 Monitor, Spanish - P/N 1060462 NM3 is a multi-parameter patient monitor that utilizes the FloTrak Elite module to perform some of the calculations.
FDA Recall
Terminated
·Respironics Novametrix, LLC.·January 4, 2011
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