10 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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WELLGRAFT PE II
FDA 510(k)
FDA Class 2
·Orthopedic
Genius Total Knee System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215022693·
Crescendo Meniscal Insert CR Standard 15mm Size 0
FDA UDI
AMPLITUDE SAS·03701089524445·
MODEL 9000 PEDIATRIC WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
DIGORA PCT
FDA 510(k)
FDA Class 2
·Dental
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013
THERA-I SR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·July 10, 2008
MINICAP TRANSFER SET
FDA Adverse Event
Death
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·April 28, 2011
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 27, 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