21 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CellFX System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIOHORIZONS INC.
FDA Adverse Event
Injury
·BIOHORIZONS INC.·Product code DZE·March 21, 2024
ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OPD-SCAN, MODELS ARK-10000 AND ARK-9000
FDA 510(k)
FDA Class 1
·Ophthalmic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 30, 2025
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·June 12, 2015
GYNECARE MORCELLEX TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·October 14, 2008
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 2, 2013
ARTICUL/EZE BALL 32 +17 WH
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·March 6, 2019
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022
M2A 1 PC SHELL 38MMX52MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·April 29, 2014
M2A 38MM MOD HEAD -3MM NK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·April 29, 2014
M2A 38MM MOD HEAD +12MM NK SKRT
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·April 29, 2014
M2A 1 PC SHELL 38MMX56MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·April 29, 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