12 results
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27ms
·
Sources: EU EUDAMED, US FDA
PRIMA BREATHING BAGS
FDA 510(k)
FDA Class 1
·Anesthesiology
"2.0" SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036056322·
iNSitu™ Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127027727·Threaded Cup Impactor, Metal Handle
VISTASEAL DUAL APPLICATOR
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code MZM·January 17, 2023
PILONPLATE WITH ANGULAR STABILITY
FDA 510(k)
FDA Class 2
·Orthopedic
Lucent Intervertebral Body Fusion Device
FDA 510(k)
FDA Class 2
·Orthopedic
SCREW,FIXATION,BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·May 18, 2015
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
FDA Adverse Event
Malfunction
·RICE CREEK MANUFACTURING·Product code DXY·February 9, 2013
ENDOTAK DSP
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·January 7, 2011
URETEX MESH PRODUCT
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·July 15, 2014
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·July 27, 2015
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024