9 results
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20ms
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Sources: EU EUDAMED, US FDA
Infrascanner
FDA 510(k)
FDA Class 2
·Ophthalmic
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383514880·"An absorbent paper points is an endodontic pap...
LIFEJET PRINTER 400
FDA 510(k)
FDA Class 2
·Radiology
PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1
FDA 510(k)
FDA Class 2
·Cardiovascular
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 29, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 8, 2013
EV1000A PLATFORM
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DXG·November 9, 2015
HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.
FDA Enforcement
Class II
·Terminated·HemoCue AB·September 18, 2013
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015