13 results
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30ms
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Sources: EU EUDAMED, US FDA
AquaShield System CO2- Fujifilm
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169600171·TRIAL 2173650 O25 IB 20MM 18 DEG 18X50
Symmetry Duval-Collins
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482056950·Symmetry® Forceps, Duval-Collins Tissue, 20 mm ...
HNM Medical
FDA UDI
HNM STAINLESS, LLC.·00842962112168·DUVAL COLLINS TISSUE FORCEPS, 8 1/4", 20MM JAW
FUJIFILM UNITY SPEEDSUITE, MODEL CR-IR 371
FDA 510(k)
FDA Class 2
·Radiology
NON-STERILE, POWDER-FREE, BLUE LATEX EXAMINATION GLOVES, WITHOUT BUBBLE GUM OR GRAPE SCENT,W/ PROTEIN CONTENT CLAIM
FDA 510(k)
FDA Class 1
·General Hospital
TROCHANTERIC NAIL KIT, TI GAMMA3 10X170MM X 125
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·September 14, 2012
NI
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code JXG·October 19, 2018
BIOGLIDE® PERITONEAL CATHETER, 8 SLITS
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·October 15, 2014
GOBED+
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 17, 2013
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 23, 2011
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018