9 results
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18ms
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Sources: EU EUDAMED, US FDA
INTERMEDICS ORTHOPEDICS DRILL BITS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515241824·Cottle Spec, 55mm blds, 10mm to 8mm taper
ALL-BOND UNIVERSAL SC (NOT FINALIZED)
FDA 510(k)
FDA Class 2
·Dental
GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·August 11, 2021
*
FDA Adverse Event
MEDTRONIC SOFAMOR DANEK·Product code HXX·December 16, 2010
KANGAROO EPUMP
FDA Adverse Event
Malfunction
·COVIDIEN·Product code LZH·January 3, 2013
UNKNOWN DEPUY PATELLAR COMPONENT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·July 14, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024