18 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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THE PHILIPS INTELLIVUE MP60, MP70, AND MP90 PATIENT MONITORS, RELEASE A.20
FDA 510(k)
FDA Class 2
·Cardiovascular
10% PVP; 10% PVP IN EBSS SOLUTION
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PALCERAM 49
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 12, 2026
MITEK EXPRESSEW III NEEDLE
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code LXH·April 2, 2013
LTV
FDA Adverse Event
Malfunction
·CAREFUSION 203, INC·Product code CBK·March 18, 2011
ACRYSOF
FDA Adverse Event
Other
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·April 18, 2008
BIOLOX DELTA CER OPTION TYPE 1 TPR SLEVE -3
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·August 19, 2025
G7 DUAL MOBILITY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·August 14, 2025
TAPERLOC COMPLETE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·August 14, 2025
G7
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·August 14, 2025
SMARTNAIL
FDA Adverse Event
Injury
·CONMED CORPORATION·Product code MAI·July 29, 2019
TRILOGY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·August 14, 2025
DUAL MOBILITY VIVACIT E
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·August 14, 2025
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
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016