10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BRAIN COIL, MODEL 9800GE-64
FDA 510(k)
FDA Class 2
·Radiology
BD SYRINGE¿ 10 ML LL BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 12, 2023
VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-GP75 TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC·Product code LON·January 14, 2019
SELOX JT 53
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·April 29, 2013
SYNGERGY
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·July 24, 2008
DUROM US ACETABULAR COMPONENT 54/48 N
FDA Adverse Event
Other
·ZIMMER GMBH·Product code KWA·April 28, 2011
TRULIANT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 29, 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