10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE
FDA 510(k)
FDA Class 2
·Neurology
NA
FDA UDI
Smith & Nephew, Inc.·03596010064806·4.0MM PARTIALLY THREADED CANNULATED SCREW 18MM
Z Liquid HT B2-C 100ml
FDA UDI
ARGEN CORPORATION, THE·D818121818·Dental porcelain/ceramic restoration kit
MIVD 1218 18 INCH GREYSCALE LCD DISPLAY MODULE
FDA 510(k)
FDA Class 2
·Radiology
SONIXGPS NEEDLE SENSOR
FDA 510(k)
FDA Class 2
·Radiology
4CIS VANE SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RIB HOOK
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code MDI·May 21, 2013
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 26, 2014
CONSTELLATION WITH LASER
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 20, 2011
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