13 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MAYO CLINIC BC-10 1.5T
FDA 510(k)
FDA Class 2
·Radiology
Audit MicroControls Control FD Assayed Chemistry, Level 1
FDA UDI
AALTO SCIENTIFIC·B085K0311100·
Insignia
FDA UDI
ORMCO CORPORATION·00889989024715·RESPOND ARCH P/F 190 DIA PK/10
INF SET CLEO 42" 9MM
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FPA·February 16, 2021
BRACHYSEED PD-103 MODELS #PD1
FDA 510(k)
FDA Class 2
·Radiology
ROVERS ENDOCERVEX-BRUSH
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ARTICUL/EZE BALL 32 +5 BR
FDA Adverse Event
Injury
·3006356043 JOHNSON & JOHNSON MEDICAL (DEPUY - SUZH·Product code JDI·April 2, 2013
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·March 17, 2011
RESPIRATORY HUMIDIFIER
FDA Adverse Event
Injury
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·April 18, 2008
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024