16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383555623·Gutta Percha Points is used to root canal filin...
6 x 15mm CitreLock Xpress Implant Kit
FDA UDI
Acuitive Technologies, Inc.·00810027270320·
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657018166·Wide Jaw Punch medium 15 degree up milled 3.5mm...
K2M General Instruments
FDA UDI
VB Spine LLC·10888857551343·Offset Blade Left Size 90 mm
SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS
FDA 510(k)
FDA Class 2
·Orthopedic
ARSTASIS ACCESS SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
NEEDLE SPINAL S/SU 27GA 3-1/2IN WHITACRE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code BSP·January 13, 2025
BD VACUTAINER® URINE COLLECTION, BULK TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code KDT·December 14, 2017
PERMACOL 10X15 1.5MM
FDA Adverse Event
Death
·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC·Product code FTL·September 3, 2013
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·May 20, 2013
ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code GKZ·September 26, 2014
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·June 10, 2011
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult Silicone King LAD¿ Patient Size: 50-70kg
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015