12 results
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36ms
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Sources: EU EUDAMED, US FDA
THERAPEUTIC DRUG (TDM) CALIBRATOR
FDA 510(k)
FDA Class 1
·Clinical Toxicology
Trimline
FDA UDI
ORMCO CORPORATION·00889989051704·UPPER RIGHT SECOND MOLAR TRIMLINE BAND SIZE 97
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR88600971·Max. 2. Molar band W-Fit left 97
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR88600970051·Max. 2. Molar band W-Fit left 97
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR88600970101·Max. 2. Molar band W-Fit left 97
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR88600970501·Max. 2. Molar band W-Fit left 97
Image Fast Set, Image Regular Set
FDA 510(k)
FDA Class 2
·Dental
GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00
FDA 510(k)
FDA Class 2
·Neurology
CAPSURE SP
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2014
UNKNOWN RIGHT NECK
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code KWL·December 4, 2012
CAREFUSION
FDA Adverse Event
Malfunction
·CAREFUSION·Product code CBK·June 19, 2015
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012