17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STATUS DS OXY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776163372·Farrior Spec Oval Oblique . m Ebonized
EVONOS GMBH & Co. Kg
FDA UDI
Gyrus ACMI, LLC·00821925014794·EAR SURGERY SPECULUM ROUND 5.0MM
Snap Fit
FDA UDI
CENTRIX, INC.·00817051023564·Snap Fit Dispenser
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776317577·Farrior Speculum
Apelo® / Apelo® MIS
FDA UDI
ATLAS SPINE, INC.·M68120101306500·6.5mm Cannulated Bone Tap
STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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
LOCKING SCREW, FULLY THREADED 5X55 MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·September 30, 2010
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·May 24, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·September 30, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011
UNKNOWN LUMBAR IMPLANT
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·April 11, 2022
INTELLAMAP ORION¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code DRF·February 18, 2016
ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020
ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019