15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MINI LED AUTOFOCUS
FDA 510(k)
FDA Class 2
·Dental
NA
FDA UDI
STERILMED, INC.·10888551021036·SAW BLADE SAGITTAL LARGE BONE
STRYKER 2000
FDA UDI
Conmed Corporation·10845854006474·STRYKER 2000 SAGITTAL BLADE REPLACEMENT, 19.5 X...
N/A
FDA UDI
STRYKER SUSTAINABILITY SOLUTIONS, INC.·00885825012052·Sagittal Saw Blade
Genius Total Knee System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215022778·
Crescendo Meniscal Insert CR Standard 17mm Size 1
FDA UDI
AMPLITUDE SAS·03701089524520·
GDC ULTRASOFT COIL
FDA 510(k)
FDA Class 2
·Neurology
NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 27, 2021
CANNULATED PARTIALLY THREADED RECONSTRUCTIVE SCREW
FDA Adverse Event
Injury
·BIOMET·Product code HSB·March 13, 2012
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013
TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX
FDA Adverse Event
Injury
·CORDIS NEUROVASCULAR, INC.·Product code HCG·April 28, 2011
CAPSURE Z NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
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