14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES (USA) CLAVICLE HOOK PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4
FDA 510(k)
FDA Class 2
·Physical Medicine
MEDIS 5MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BD VACUTAINER TUBE PST GEL AND LIHE 83 UNITS
FDA Adverse Event
Malfunction
·BD·Product code JKA·July 24, 2018
AN UNSPECIFIED CLOSED SYSTEM ART LINE TRANSUDUCER
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·March 18, 2025
UNSPECIFIED SAFESET TRANSPAC SETS
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·January 2, 2025
UNSPECIFIED CENTRAL LINE TRANSDUCER SET
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·November 5, 2024
AN UNSPECIFIED CLOSED SYSTEM ART LINE SYRINGE
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·March 18, 2025
FOUNDATION KNEE
FDA Adverse Event
ENCORE MEDICAL, L.P.·Product code JWH·April 16, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 18, 2011
GYNECARE MORCELLEX TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·June 13, 2008
BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·August 7, 2018
BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·July 11, 2018
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015