10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
NOA III ENTERAL NUTRITION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
HairCheck-DT (THC)
FDA UDI
Quest Diagnostics·00868586000247·HairCheck-DT (THC) is an ELISA test kit used fo...
HOFFMANN II EXTERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
QUELL DESENSITIZER
FDA 510(k)
FDA Class 2
·Dental
POLARIS 5.5 TITANIUM SPINAL SYSTEM
FDA Adverse Event
Malfunction
·EBI, LLC.·Product code MNI·April 8, 2013
LEGEND XT 2CH STIM PKG1 2770 STIM MODULE CH
FDA Adverse Event
Injury
·DJ ORTHOPEDICS DE MEXICO·Product code IMG·March 25, 2011
ACCU-CHEK COMPACT PLUS METER
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·May 2, 2008
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018