13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V
FDA 510(k)
FDA Class 2
·Cardiovascular
RAD-5V HANDHELD
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·July 10, 2015
RAD-5 PULSE OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·July 13, 2018
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033998·Baltic Denture System BDLoad BDLoad Sw6 PLSEbm...
POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
FLEXVIEW CLINICAL MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
RADIESSE DERMAL FILLER
FDA Adverse Event
Other
·MERZ AESTHETICS, INC.·Product code LMH·November 7, 2012
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·April 3, 2013
ALTRX NEUT 32IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·March 17, 2011
KIT, PLEURX PLEURAL CATHETER
FDA Adverse Event
Injury
·CARDINAL HEALTH·Product code KDQ·April 25, 2008
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
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024
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