14 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D
FDA 510(k)
FDA Class 2
·Clinical Chemistry
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221036858·Unitek(TM) Bicuspid Band General Purpose Narrow...
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973101406·Poly Insert MPCS, Size 1R, 14mm
Spira-A
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030CG1411140·Ferris Smith Pituitary Rongeur, Up, 12", 4mm Ti...
Plateau-C Ti
FDA UDI
Life Spine, Inc.·00190837068691·14mmx11mmx14mm Plateau-C Spacer
SURESIGNS VS2+ NBP/SPO2/WIRELESS
FDA Adverse Event
Malfunction
·PHILIPS NORTH AMERICA LLC·Product code MHX·August 26, 2021
INRATIO
FDA Adverse Event
Malfunction
·BIOSITE INCORPORATED·Product code JPA·March 6, 2009
PROFEMUR TAPERED HIP STEM
FDA 510(k)
FDA Class 3
·Orthopedic
ADVANCIS ACTIVON TUBE
FDA 510(k)
FDA Unclassified
·Unknown
Widex
FDA UDI
Widex A/S·05706069886580·WIDEX MOMENT MRB0 (Honey blond ) 440, RIC 10
SUMMIT POR TAPER SZ3 HI OFF
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·June 3, 2013
ENDEAVOR RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·June 21, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 3, 2014
Azurion 5 M12; System Code: (1)722227, (2)722231;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026