9 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HICKMAN TITANIUM SUBCUTANEOUS PORT
FDA 510(k)
FDA Class 2
·General Hospital
BC-001+ Acne Purifier
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE H.0
FDA 510(k)
FDA Class 2
·Cardiovascular
X3 TRIATHLON CS INSERT #3 13MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·June 12, 2014
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 11, 2010
ADAPT¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIM·December 12, 2012
RGX 3 PEG SER A PATELLA 31MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·March 11, 2021
Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/A
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024