10 results
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28ms
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Sources: EU EUDAMED, US FDA
SUNSATION
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VITROS
FDA UDI
ORTHO CLINICAL DIAGNOSTICS·10758750001224·VITROS Immunodiagnostic Products Anti-HBc Calib...
Oph.Forceps
FDA UDI
KATENA PRODUCTS, INC.·00852979003878·Inamura Capsulorrhexis Cystotome Forceps
THD SLIDE
FDA 510(k)
FDA Class 2
·Radiology
MODIFICATION TO ACCUDEXA BONE DENSITOMETER
FDA 510(k)
FDA Class 2
·Radiology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 8, 2014
PCA ACE/DEEP SOCKET SHELL 55MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·October 17, 2012
PRECISION XTRA/OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, LTD., UK·Product code NBW·September 25, 2007
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
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