21 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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MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE
FDA 510(k)
FDA Class 2
·Anesthesiology
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890123950·Zirlux Shading Liquid - Dentin, D3, 100ml
G-aenial™
FDA UDI
Gc America Inc.·D0470123951·G-aenial™ Bulk Injectable A2
G-aenial™
FDA UDI
Gc America Inc.·14548161328739·G-aenial™ Bulk Injectable A2
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033397671·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033397664·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033397701·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033397657·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033397695·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033397718·
E-POWER
FDA 510(k)
FDA Class 2
·Physical Medicine
MODEL 30 CLASSIC PNEUMATONOMETER
FDA 510(k)
FDA Class 2
·Ophthalmic
RING ANNULOPLSTY TRICUSP CONTOUR 3D 26MM
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 10, 2019
NKS PM-L
FDA Adverse Event
Injury
·NAKANISHI INC. (NSK)·Product code EFB·May 26, 2015
DESARA
FDA Adverse Event
Injury
·CALDERA MEDICAL, INC.·Product code PAH·March 7, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·March 9, 2011
UNK - UNSPECIFIED BY THE COMPLAINANT
FDA Adverse Event
Injury
·COOK BIOTECH, INC.·Product code FTM·July 31, 2014
OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·June 26, 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
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022