17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·July 21, 2017
CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019
ECG Module(AHA)
FDA UDI
SAMSUNG MEDISON CO., LTD.·08806167712532·
AGXO
FDA UDI
Oticon A/S·05707131285072·H160V2, RITE 312 WL DBL AGXO
Resection Stylus
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215057008·
HBA1C ENZYMATIC ASSAY
FDA 510(k)
FDA Class 2
·Hematology
ESTELITE COLOR
FDA 510(k)
FDA Class 2
·Dental
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
FDA Adverse Event
Injury
·ELLIPSE TECHNOLOGIES, INC.·Product code PGN·June 23, 2014
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
FDA Adverse Event
Injury
·ELLIPSE TECHNOLOGIES, INC.·Product code PGN·May 25, 2014
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
FDA Adverse Event
Injury
·ELLIPSE TECHNOLOGIES, INC.·Product code PGN·May 21, 2014
APPLIANCE,FIXATION,SPINAL INTERLAMINAL
FDA Adverse Event
Injury
·SYNTHES USA·Product code KWP·October 7, 2014
COLLEAGUE PRE-P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011
EZ BREATHE ATOMIZER
FDA Adverse Event
HEALTH & LIFE (SUZHOU) CO., LTD.·Product code CCQ·June 4, 2013
MICROVASCULAR PLUG
FDA Adverse Event
Injury
·REVERSE MEDICAL·Product code KRD·September 8, 2021
MICROVASCULAR PLUG
FDA Adverse Event
Injury
·REVERSE MEDICAL·Product code KRD·September 8, 2021
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024