11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER
FDA 510(k)
FDA Class 2
·Orthopedic
145-DEG PE 36MM HUM LINER +0
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·December 10, 2024
Victoria Klein
FDA UDI
Diversified Products, Inc.·00842894127131·
SYNTHES SYNMESH SPACER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ASTRALIS 10, MODELS # 559588, 561859
FDA 510(k)
FDA Class 2
·Dental
LIFEPAK CR(R) PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·December 10, 2018
COULTER® LH 500 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·May 6, 2013
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
FDA Adverse Event
Malfunction
·XOFT, A SUBSIDARY OF ICAD·Product code JAD·September 16, 2014
7MM EXTENDED LENGTH ENDOSCOPE
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR·Product code GCJ·April 14, 2011
NUVASIVE HELIX ACP SYSTEM
FDA Adverse Event
Malfunction
·NUVASIVE, INC.·Product code KWQ·June 1, 2022
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