10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DISPOSABLE GROUNDING PAD SERIES AND ELECTRODE SERIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EASYTRAK MIDDLEWEIGHT GUIDE WIRE
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS·Product code DTB·February 9, 2004
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
NEB100
FDA Adverse Event
Malfunction
·SUNSET HEALTHCARE SOLUTIONS·Product code CAF·January 29, 2019
DPM CENTRAL STATION/TRANSMITTER
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC·Product code MHX·April 30, 2013
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 22, 2014
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·April 29, 2011
Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile. Zimmer, Non Sterile, Rx Only. Screwdriver: Customer Number/Model: 804-03-038 T11623, T14001 T14001, MTO35173507 T14378, MTO375173506 T14379, MTO35173505 T14380, MTO35175303 T8127.
FDA Enforcement
Class II
·Terminated·Greatbatch Medical·June 8, 2016
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