12 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120235501·Carbide, round, rosehead, fast cutting and low ...
CLIRANS E-SERIES DIALYZER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INFINITY ETCO2 + RESPIRATORY MECHANICS POD
FDA 510(k)
FDA Class 2
·Anesthesiology
ILAB ULTRASOUND IMAGING SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (CE)·Product code IYO·March 27, 2013
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·March 16, 2011
SLALOM PTA DILATATION CATHETER
FDA Adverse Event
Malfunction
·CORDIS EUROPA, N.V.·Product code LIT·March 31, 2008
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·August 30, 2019
KINETRA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·July 2, 2019
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
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018