27 results
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19ms
·
Sources: EU EUDAMED, US FDA
L-CATH CONNECTOR ASSEMBLY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994120175·INSTRUMENT 2940198 12-14MM INTBDY DSTRTR
VARIAX
FDA UDI
Stryker GmbH·07613327365207·Insert DR & Wrist Spanning Plates
IMDX HSV-1/2 FOR ABBOTT M2000
FDA 510(k)
FDA Class 2
·Microbiology
LABONE COCAINE METABOLITE MICRO-PLATE EIA
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 2, 2013
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·December 23, 2010
PROCEED* MULTI-LAYER LAMINATE MESH
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code FTL·July 17, 2014
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