12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TriMed Nitinol Staple System
FDA 510(k)
FDA Class 2
·Orthopedic
CLEARCUT S SAFETY KNIFE
FDA 510(k)
FDA Class 1
·Ophthalmic
AVS ANTERIOR LARGE PEEK SPACERS
FDA 510(k)
FDA Class 2
·Orthopedic
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 19, 2020
GALAXY G3 MINI 1MM X 4CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·June 19, 2020
GRAFT
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES, INC·Product code MIH·April 24, 2007
IDRIVE ULTRA POWERED HANDLE 1
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY US SURGICAL·Product code GDW·June 10, 2013
PRIME CARE (R) TRANSCEND ADVANCED MATTRESS PER
FDA Adverse Event
Malfunction
·PRIMUS MEDICAL LLC·Product code IKY·September 18, 2014
GALAXY G3 MINI 1MM X 4CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·October 1, 2022
CD HORIZON ASTUTE SPINAL SYSTEM
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code NQP·April 16, 2021
NCIRCLE TIPLESS STONE EXTRACTOR
FDA Adverse Event
Malfunction
·COOK INC·Product code FFL·January 15, 2019
Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024