18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMARTMONITOR 2, MODEL 4000
FDA 510(k)
FDA Class 2
·Anesthesiology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040011034·Zirlux 16+ 0M1 100X25
READERS CHOICE
FDA UDI
FGX INTERNATIONAL INC.·00193033299470·
READERS CHOICE
FDA UDI
FGX INTERNATIONAL INC.·00193033299463·
READERS CHOICE
FDA UDI
FGX INTERNATIONAL INC.·00193033299494·
READERS CHOICE
FDA UDI
FGX INTERNATIONAL INC.·00193033299302·
READERS CHOICE
FDA UDI
FGX INTERNATIONAL INC.·00193033299449·
READERS CHOICE
FDA UDI
FGX INTERNATIONAL INC.·00193033299371·
READERS CHOICE
FDA UDI
FGX INTERNATIONAL INC.·00193033299401·
SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT
FDA 510(k)
FDA Class 2
·Immunology
CONMED TROGARD FINESSE TROCAR SYSTEM, MODEL 60-6050-XXX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CONTACT DETACH
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 27, 2025
CONTACT DETACH
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 27, 2025
18 G X 1.25 IN. (1.3 MM X 31 MM) BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·September 21, 2017
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code LFR·May 16, 2007
XIA TITANIUM 4.5 BLOCKER
FDA Adverse Event
Malfunction
·STRYKER SPINE-FRANCE·Product code NKB·March 19, 2013
HIRES 90K
FDA Adverse Event
Injury
·ADVANCED BIONICS LLC·Product code MCM·March 1, 2011
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