14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FDA 510(k)
FDA Class 2
·Clinical Chemistry
MILAGRO
FDA UDI
Medos International Sàrl·10886705022298·MILAGRO ADVANCE INTERFERENCE SCREW Absorbable -...
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116022540·600 micron core/1040 micron OD Luer Lock Diode ...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694022279·FPS 2.7mm On-Bone Plate Bender
COBAS INTEGRA CHOLESTEROL GEN. 2
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AVAFLEX VERTEBRAL BALLOON SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GRIPPER PLUS NEEDLE
FDA Adverse Event
Injury
·SMITHS MEDICAL MD (FORMERLY DELTEC, INC)·Product code FMI·November 11, 2008
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
MEDTRONIC SOFAMOR DANEK·Product code KWP·September 1, 2011
PERCUTANEOUS REFERENCE CROSS PIN FRAME
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·December 11, 2012
ABSOLUTE G-W NTNL 1.1MMX15 6PK
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code FZX·November 15, 2019
MILAGRO ADVANCE SCREW 11X30MM
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code HWC·November 15, 2019
CORTICAL FXATION FXD LOOP 15MM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL·Product code MBI·November 15, 2019
INTRAFIX TAPERED SCREW 7-9MM X 30MM (ACETAL/DELRIN)
FDA Adverse Event
Injury
·DEPUY MITEK·Product code MBI·July 21, 2014
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024