10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANGIOPTIC ANGIOGRAPHIC CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
CO2 LASERS AND INFRAGUIDE DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES
FDA 510(k)
FDA Class 1
·Microbiology
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MPRI·Product code NVY·February 11, 2013
PFC CVD 8MM SZ4
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·January 5, 2011
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
JIANGSU YUYUE MEDICAL EQUIP.·Product code IKX·July 24, 2014
RESTORIS PST Acetabular Straight Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
FDA Recall
Terminated
·Mako Surgical Corporation·Product code OLO·October 7, 2014
RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
FDA Recall
Terminated
·Mako Surgical Corporation·Product code OLO·October 7, 2014
RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
FDA Recall
Terminated
·Mako Surgical Corporation·Product code OLO·October 7, 2014
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024