20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FIXED, VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Cook
FDA UDI
COOK INCORPORATED·00827002141865·Fascial Dilator
Specials
FDA UDI
Seaspine Orthopedics Corporation·10889981286217·Offset Retractor Blade (Right), 80mm
ADVANTAGE THC/COCAINE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
REFERENCE CHECK, CATALOG NUMBER-RCN-10
FDA 510(k)
FDA Class 2
·Hematology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 29, 2024
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 11, 2025
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 3, 2025
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 23, 2025
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 27, 2024
880 HUMIDIFICATION SYSTEM
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 31, 2010
ASR ACETABULAR IMPLANT 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 23, 2013
VERTICAL MICROSCISSORS, 1.0MM, DISP
FDA Adverse Event
Malfunction
·ALCON GRIESHABER AG·Product code HQE·April 13, 2011
OLYMPUS
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FAK·July 1, 2008
880 HUMIDIFICATION SYSTEM
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD.·Product code BTT·February 15, 2010
RESPIRATORY HUMIDIFIER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 12, 2024
RESPIRATORY HUMIDIFIER
FDA Adverse Event
Injury
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 4, 2024
880 HUMIDIFICATION SYSTEM
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·April 15, 2010
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 6, 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