11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
Medos International Sàrl·10886705029228·ADAPTOR WOLF LIGHT SOURCE UNIVERSAL TIP
Sklar®
FDA UDI
SKLAR CORPORATION·10649111386619·SMITH WIRE CUT SCISS STR 7"
DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D
FDA 510(k)
FDA Class 2
·Radiology
Discovery MR750 3.0T
FDA 510(k)
FDA Class 2
·Radiology
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 2, 2023
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 10, 2011
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·November 11, 2014
CRE? WIREGUIDED
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KNQ·July 23, 2013
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025