12 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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TILITE YG AND TILITE YGS
FDA 510(k)
FDA Class 1
·Physical Medicine
HairCheck-DT (Cocaine)
FDA UDI
Quest Diagnostics·00868586000209·HairCheck-DT (Cocaine) is an ELISA test kit use...
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120236061·Carbide - Excavating and fissure burs
ACS 180 HOMOCYSTEINE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NVA-63-8 NEUROVASCULAR ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
ZYGOMATIC IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·July 17, 2025
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·February 15, 2024
PRONOVA BLUE MONO POLY(HEXAFLUOROPROPYLENE)SUTURE
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code GAW·March 27, 2013
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Other
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·February 4, 2011
ACRYSOF RESTOR
FDA Adverse Event
Other
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·March 28, 2008
Advisor Vital Signs Monitor (model 9200), catalog number 925754225, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 5-lead 60 Hz ECG, standard SPO2 and battery.
FDA Recall
Terminated
·Smiths Medical PM, Inc.·Product code DPS·September 1, 2005
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