11 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STATNET, MODEL 3100
FDA 510(k)
FDA Class 2
·Neurology
PORTA SMK 82, MODEL 2032
FDA 510(k)
FDA Class 2
·Dental
XPS NITRO SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
RAD-8
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·July 15, 2015
KYPHX® HV-R? BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code NDN·March 14, 2014
KYPHX® HV-R? BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code NDN·June 20, 2014
UNSPECIFIED SAFESET TRANSPAC SETS
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·January 2, 2025
HEMOCHRON JR. SIGNATURE PLUS SYSTEM
FDA Adverse Event
Injury
·INTERNATIONAL TECHNIDYNE CORP.·Product code JPA·May 11, 2011
UV FLASH TRANSFER SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 3, 2013
ARDIS PEEK IMPLANT 09X09X22
FDA Adverse Event
Malfunction
·ZIMMER SPINE·Product code MAX·August 20, 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