11 results
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18ms
·
Sources: EU EUDAMED, US FDA
CONPHAR PALM ANEROID SPHYGMOMANOMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Mini Twin
FDA UDI
Rmo, Inc.·00885797652782·ROTH MINI LP 018 HK/345 5-5 20EA
Bioplate®
FDA UDI
Bioplate, Inc.·M3848133021·Straight Plate - Ø1.5 mm - 2 hole - 14 mm [50 PK]
SnuggleFit
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377022555·SnuggleFit Infant Effort Belt - Embla
NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS
FDA 510(k)
FDA Class 2
·General Hospital
DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 15, 2014
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·October 31, 2012
TI VECTRA
FDA Adverse Event
Malfunction
·SYNTHES·Product code KWQ·July 22, 2010
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
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018