10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Crosser iQ CTO Recanalization System
FDA 510(k)
FDA Class 2
·Cardiovascular
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113974·HYDRO-DISSECT CANNULA 25GA ANGLED 8MM
M2A 32MM TAPER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ZEUS ELISA HSV GC-I IGG TEST SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
PROSTHESIS, HIP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWY·November 11, 2021
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code NIQ·October 15, 2008
ASKU
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DTE·August 11, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·July 2, 2013
Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare, Llc·November 20, 2013
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