14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LEONE SPA
FDA UDI
LEONE SPA·08033707065807·EXTRAORAL ELASTIC KIT
KIMAX REMOTE VIEWING STATION
FDA 510(k)
FDA Class 2
·Radiology
ACCESS ULTRASENSITIVE HGH CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SPINAL 22G WHITACRE FORTEX
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD INC.·Product code CAZ·March 17, 2016
VELA VENTILATOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code CBK·July 21, 2015
VELA VENTILATOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code CBK·February 19, 2015
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 3, 2013
NEONATE PACK
FDA Adverse Event
Malfunction
·DATASCOPE CORP·Product code DSP·August 21, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 3, 2011
PORTEX® SPINAL ANESTHESIA TRAYS
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD INC.,·Product code CAZ·April 14, 2016
NONE
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·February 22, 2023
PORTEX® SPINAL ANESTHESIA TRAYS
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD INC.,·Product code CAZ·April 14, 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