11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600
FDA 510(k)
FDA Class 2
·General Hospital
MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
REMSTAR AUTO CPAP SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 8, 2024
H 105700#TUBING SET
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DWE·May 5, 2015
HQV 32902#INTEGRATED ADULT PACK
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DWE·June 22, 2015
ASR ACETABULAR IMPLANT 60
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 29, 2013
MICRO SAGITTAL SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·April 28, 2011
IPG
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code EZW·July 25, 2008
MAYFIELD MODIFIED SKULL CLAMP
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES CORPORATION OH/USA·Product code HBL·August 11, 2018
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