13 results
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20ms
·
Sources: EU EUDAMED, US FDA
PIONEER CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·20304040003637·Blu-Bite HP Rigid Fast Set
Genius Total Knee System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215022600·
Crescendo Meniscal Insert CR Standard 11mm Size 5
FDA UDI
AMPLITUDE SAS·03701089524285·
G-THAWKIT BLAST
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS
FDA 510(k)
FDA Class 2
·Radiology
SIMULUS SEMI-RIGID ANNULOPASTY RING
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 10, 2020
DEKA SMARTXIDE WITH DOT SCANNER
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·November 14, 2023
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013
DIMENSION® CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD·Product code JJE·April 28, 2011
CAPSURE SP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008
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