12 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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EMBRACE DUAL CURE COMPOSITE MATERIALS
FDA 510(k)
FDA Class 2
·Dental
KOMET Surgical Saw Blade
FDA UDI
Gebr. Brasseler GmbH & Co. KG·14053613201909·
KOMET Surgical Saw Blade
FDA UDI
Gebr. Brasseler GmbH & Co. KG·14053613201923·
KOMET Surgical Saw Blade
FDA UDI
Gebr. Brasseler GmbH & Co. KG·14053613275092·
KOMET Surgical Saw Blade
FDA UDI
Gebr. Brasseler GmbH & Co. KG·14053613201947·
EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SENSAIRE DIAGNOSTIC SPIROMETER
FDA 510(k)
FDA Class 2
·Anesthesiology
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·April 9, 2013
REALSEAL POINTS
FDA Adverse Event
Injury
·SYBRONENDO·Product code EKM·September 9, 2014
TAPERED SPACER ARTICUL/EZE +0
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LZY·July 7, 2008
CT EXPRES
FDA Adverse Event
Injury
·BRACCO INJENEERING S.A.·Product code IZQ·September 27, 2023
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