11 results
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24ms
·
Sources: EU EUDAMED, US FDA
PROSTHESIS, TOTAL HIP-TEST FEMORAL
FDA 510(k)
FDA Class 2
·Orthopedic
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110546·QUICK SWITCH IRRIGAT-ASPIRAT HAND PIECE
The Orthodontic Store
FDA UDI
Young Innovations, Inc.·00843471177853·Anatomical Molar Bands, Upper Left 1St & 2Nd Mo...
DiamondTOUCH Inflation Device and Fluid Dispensing Syringe
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
FLOGARD
FDA Adverse Event
Malfunction
·SHARP CORPORATION OSAKA JAPAN·Product code FRN·April 18, 2014
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·September 26, 2012
INTELLIVUE MULTI MEASUREMENT SERVER X2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·July 9, 2010
SCRDRIVER SHAFT 3.5 T15 SELF-HOLDING F/A
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXX·January 13, 2023
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Model Number U228, VISIONIST CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025