8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO: PROVIDENCE ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BIOCELLECT
FDA 510(k)
FDA Class 2
·Dental
HEART 2005
FDA 510(k)
FDA Class 2
·Cardiovascular
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·April 22, 2013
COATED VICRYL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Injury
·ETHICON, INC·Product code GAM·April 27, 2011
PLEUR-EVAC
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code KDQ·June 26, 2008
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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