15 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CA, MODEL: CAM
FDA 510(k)
FDA Class 2
·Ophthalmic
Harvard Ionoresin Fill OptiCaps A2
FDA UDI
Harvard Dental International GmbH·EHAR70712501·Resin modified glass ionomer cement for restora...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293173·
Sklar®
FDA UDI
SKLAR CORPORATION·10649111096129·F.O. MILLER AMER STYLE SIZE 4
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CUB PEDIATRIC CRIB- FIXED BASE
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FMS·April 22, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 27, 2011
SELF CENT HIP 47X32 BRN
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWY·July 7, 2008
HEARTMATE 3 LVAS IMPLANT KIT
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·March 14, 2023
HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·March 15, 2023
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 27, 2025
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·January 8, 2021
GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·July 30, 2014
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