9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Zenius, lliad and Kora Spinal Fixation Systems
FDA 510(k)
FDA Class 2
·Orthopedic
POWER-FREE NITRILE PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV
FDA 510(k)
FDA Class 2
·Anesthesiology
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013
VITALITY
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 21, 2011
ASP AUTOMATIC ENDOSCOPE REPROSSOR WITH PRINTER
FDA Adverse Event
Malfunction
·UNITROL/MINNTECH COR·Product code FEB·September 17, 2008
ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code FCG·December 26, 2017
ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·December 10, 2020
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·October 27, 2021