27 results
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20ms
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Sources: EU EUDAMED, US FDA
SURESOFT SURGICAL GLOVES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
XLIF
FDA UDI
Nuvasive, Inc.·00887517406361·XLIF Cobb, 18mm Angled Down
N/A
FDA UDI
Tyber Medical, LLC·M695M9402180·
TRIGLYCERIDE AQUEOUS STANDARDS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Electric Breast Pump (F5055)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
I-STAT CHEM8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·September 17, 2019
I-STAT CHEM8+ CARTRIDGE (SEE H10 FOR EC8+)
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 7, 2017
MODEL B 110 V ELECTRO DERMATOME COMPLETE KIT
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES CORPORATION OH/USA·Product code FZW·June 19, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 2, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP·Product code MKJ·December 9, 2010
I-STAT CHEM8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·February 15, 2022
I-STAT CARTRIDGE
FDA Adverse Event
Injury
·ABBOTT POINT OF CARE·Product code CHL·August 8, 2014
I-STAT CHEM8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·March 30, 2023
I-STAT CG4+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code KHP·January 5, 2022
I-STAT CG4+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code KHP·January 5, 2022
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Recall
Open, Classified
·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Enforcement
Class II
·Ongoing·Abbott Point Of Care Inc.·September 24, 2025
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
iStat1 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 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.
FDA Enforcement
Class II
·Terminated·Abbott Point Of Care Inc.·July 18, 2012
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