24 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ODYSSEY®
FDA UDI
Microport Orthopedics Inc.·M684K00143871·
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001387·artVeneer life lower anteriors, UBL, C3
Diagon
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030MO0013870·"Off-Set, Bi-Convex, 12mm x 34mm x 17mm, Obliq...
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970164·
PTA BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
TERUMO NEEDLE WITH LOCKING SHEATH
FDA 510(k)
FDA Class 2
·General Hospital
2520274-2013-01425
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·March 13, 2013
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code DQX·February 25, 2011
GE OEC 9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·February 22, 2008
MENTOR SMOOTH ROUND HIGH PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·May 2, 2019
HLM TUBING SET
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTM·July 6, 2016
CNS-6201A
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·March 7, 2018
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood 510 K940918 Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K 001387
FDA Recall
Terminated
·Abbott Point Of Care Inc.·Product code CHL·September 8, 2011
Military Kit Portable Clinical Analyzer ; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood 510 K940918 Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K 001387
FDA Recall
Terminated
·Abbott Point Of Care Inc.·Product code CHL·September 8, 2011
Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood 510 K940918 Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K 001387
FDA Recall
Terminated
·Abbott Point Of Care Inc.·Product code CHL·September 8, 2011
i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood 510 K940918 Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K 001387
FDA Recall
Terminated
·Abbott Point Of Care Inc.·Product code CHL·September 8, 2011
Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood 510 K940918 Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K 001387
FDA Enforcement
Class II
·Terminated·Abbott Point Of Care Inc.·July 18, 2012
i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood 510 K940918 Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K 001387
FDA Enforcement
Class II
·Terminated·Abbott Point Of Care Inc.·July 18, 2012
Military Kit Portable Clinical Analyzer ; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood 510 K940918 Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K 001387
FDA Enforcement
Class II
·Terminated·Abbott Point Of Care Inc.·July 18, 2012