9 results
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22ms
·
Sources: EU EUDAMED, US FDA
NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICAL WORKSTATION
FDA 510(k)
FDA Class 2
·Neurology
TWINTRODE ELC 134 ELECTRODE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 8, 2025
CANES
FDA Adverse Event
Malfunction
·HL CORP. (SHENZHEN)·Product code IPS·April 29, 2011
OPTETRAK
FDA Adverse Event
Other
·EXACTECH, INC.·Product code JWH·April 23, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP.·Product code MKJ·July 23, 2008
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 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