12 results
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38ms
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Sources: EU EUDAMED, US FDA
CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML)
FDA 510(k)
FDA Class 2
·General Hospital
M2430 DIAGNOSTIC ULTRASOUND SYSTEM WITH THE 21420 TRANSDUCER
FDA 510(k)
FDA Class 2
·Radiology
URISYS 2400 URINE TEST STRIP
FDA 510(k)
FDA Class 2
·Clinical Chemistry
QUIK-COMBO PACING/DEFIBRILLATION/ECG
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL CORP·Product code LDD·March 31, 1998
IMP,1-PC,ANG,3.0X13MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·September 19, 2024
IMP,1-PC,ANG,3.0X13MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·October 11, 2019
EON
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 3, 2013
AUTOMATE 800 SAMPLE PROCESSING SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·April 12, 2011
BREEZY ULTRA 4 WHEELCHAIR
FDA Adverse Event
Malfunction
·SUNRISE MEDICAL·Product code IOR·May 22, 2008
OXYSURE
FDA Adverse Event
Injury
·OXYSURE·Product code CAW·March 19, 2014
OXYSURE
FDA Adverse Event
Injury
·OXYSURE·Product code DQA·March 19, 2014
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