11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANAX OCT Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
Oticon
FDA UDI
Sbo Hearing A/S·05714464088287·OTICON JET 2 CIC
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331142130·littauer stitch scissors, 5 1/2" (14.0 cm)
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221049780·Unitek(TM) Permachrome Standard Stainless Steel...
DigitalDiagnost C50
FDA 510(k)
FDA Class 2
·Radiology
STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
FDA 510(k)
FDA Class 2
·General Hospital
CMD 25-1725 PROMADE HIP
FDA Adverse Event
Malfunction
·LIMACORPORATE S.P.A.·Product code LPH·May 26, 2026
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 14, 2014
ALARIS PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORP.·Product code FPA·August 31, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 29, 2013
STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT).
FDA Enforcement
Class II
·Terminated·Diagnostica Stago, Inc.·March 21, 2018