30 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
3DP Lumbar Interbody System
FDA UDI
Genesys Orthopedics Systems LLC·M719GL3DM1230080·Medium 8-Degree 3DP LLIF - 12mm x 30mm
3DP Lumbar Interbody System
FDA UDI
Genesys Orthopedics Systems LLC·M719GL3DS1230080·Small 8-Degree LLIF - 12mm x 30mm
3DP Lumbar Interbody System
FDA UDI
Genesys Orthopedics Systems LLC·M719GL3DL1230080·Large 8-Degree 3DP LLIF - 12mm x 30mm
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K1230010·Rod Holder, Straight, 5.5 mm
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K1230000·Rod Holder, Curved, 5.5 mm
MultiStage®
FDA UDI
Dongguan TT Medical, Inc.·06934184004490·
MultiStage®
FDA UDI
Dongguan TT Medical, Inc.·06934184004131·
BD BBL¿ MACCONKEY II AGAR
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSI·August 2, 2024
UNIVERSAL SYSTEM, MODEL QV-800
FDA 510(k)
FDA Class 2
·Radiology
INZONE DETACHMENT SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
PMT INTEGRA TISSUE EXPANDER
FDA Adverse Event
Other
·PMT CORPORATION·Product code LCJ·May 28, 2010
ENDOVIVE STANDARD PEG KITS PUSH METHOD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNT·January 6, 2009
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 22, 2024
ADVIA CENTAUR CP
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code MMI·May 21, 2013
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·September 26, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 14, 2011
Artis Q.zen biplane, Material no. 10848355, for angiography and whole body radiographic/fluoroscopic procedures.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 4, 2018
Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2020
Artis Q systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 12, 2015