13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Miro3D Fibers Wound Matrix
FDA 510(k)
FDA Unclassified
·Unknown
inCoris ZI
FDA UDI
SIRONA Dental Systems GmbH·E27662407532·inCoris ZI maxi S F2 1 St/pcs.
Sonic
FDA UDI
Sbo Hearing A/S·05714464057481·SONIC RADIANT 20 MNR T DG
QUANTUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code LWP·April 6, 2017
ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
R-TEST EVOLUTION 3
FDA 510(k)
FDA Class 2
·Cardiovascular
KARDIAMOBILE
FDA Adverse Event
Malfunction
·ALIVECOR·Product code DPS·January 24, 2022
FORTIFY ST DR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·November 10, 2014
LOW PROFILE REAMER 11MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code LXH·September 9, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 22, 2013
BD ALARIS PUMP MODULE SMARTSITE BLOOD INFUSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS S.A. DE C.V.·Product code FPA·January 7, 2025
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
FDA Enforcement
Class I
·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018