14 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OMNIGUIDE ZERO FLOW ZF-T 150 WAVEGUIDE FIBER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MICROGYN PLUS STIMULATION DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UBM PLUS, MODEL P45
FDA 510(k)
FDA Class 2
·Radiology
SEXTANT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·October 1, 2010
ERBE
FDA Adverse Event
Malfunction
·LEONHARD LANG GMBH·Product code GEI·October 21, 2020
KLS MARTIN
FDA Adverse Event
Malfunction
·LEONHARD LANG GMBH·Product code GEI·November 17, 2020
AED PLUS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 27, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·June 20, 2008
AED PLUS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 12, 2011
ERBE
FDA Adverse Event
Injury
·LEONHARD LANG GMBH·Product code GEI·October 23, 2024
OSSEOTITE CERTAIN IMPLANT 4 X 11.5MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code DZE·December 18, 2023
ERBE
FDA Adverse Event
Malfunction
·LEONHARD LANG GMBH·Product code GEI·September 20, 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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015