9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANASEPT ANTIMICROBIAL SKIN AND WOUND CLEANSERS; ANASEPT ANTIMICROBIAL SKIN AND WOUND GEL
FDA 510(k)
FDA Unclassified
·Unknown
NUGARD DG POWDERED GREEN-MINT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
BABYCOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 29, 2024
BIOLOX OPTION, HEAD, S, 44/-3.0, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·December 12, 2018
TRIMA ACCEL
FDA Adverse Event
TERUMO CORPORATION/TERUMO BCT·Product code GKT·April 23, 2013
SPECTRUM
FDA Adverse Event
SIGMA·Product code FRN·April 18, 2011
DURATA STS OPTIM ACTIVE-FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
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