10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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THE KARL STORZ HAMOU ENDOMAT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SeaSpine Spacer System - Redondo™
FDA UDI
Seaspine Orthopedics Corporation·10889981045319·Trial 30mm x 24mm x 21mm, Lordotic
ALKO CALIBRATION FOR AMDEV LYTENING SYSTEMS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DURACON UNICOMPARTMENTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TI MULTILOC END CAP F/MULTILOCNAIL/0MM EXTENSION-STERILE
FDA Adverse Event
Malfunction
·SYNTHES SALZBURG·Product code HSB·October 21, 2016
MYNX
FDA Adverse Event
Malfunction
·ACCESS CLOSURE·Product code MGB·December 9, 2010
FENESTRATED BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·January 30, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·July 15, 2014
TI MULTILOC END CAP F/MULTILOCNAIL/5MM EXTENSION-STERILE
FDA Adverse Event
Malfunction
·SYNTHES SALZBURG·Product code HSB·October 21, 2016
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