20 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FINDER G6PD
FDA 510(k)
FDA Class 2
·Hematology
10M - Southwest Gas Corp
FDA UDI
Certified Safety Manufacturing, Inc.·00766588010434·10M - Southwest Gas Corp
24M - Tampa Electric Co.
FDA UDI
Certified Safety Manufacturing, Inc.·00766588013497·24M Tampa Electric Co.
24M - Southwest Gas Corp
FDA UDI
Certified Safety Manufacturing, Inc.·00766588010441·24M - Southwest Gas Corp
OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
GUTHRIE POWDER-FREE LATEX SURGICAL GLOVE WITH (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, MICROCLAVE®, 03 ML SAF
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·June 16, 2022
XMAX MOTOR, HIGH STRENGTH HOSE
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code ERL·October 27, 2014
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·July 1, 2011
NC QUANTUM APEX BALLOON CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·July 2, 2013
INJECTOR LOCKING N40-O
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·September 15, 2021
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·May 15, 2022
BD PHASEAL OPTIMA INJECTOR (N40-O)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·September 14, 2021
TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, MICROCLAVE®, 03 ML SAF
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·June 16, 2022
INJECTOR LOCKING N40-O
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·September 21, 2021
Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·April 3, 2013
TOSHIBA Kalare Diagnostic X-Ray System K110785
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·July 17, 2013
CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.
FDA Enforcement
Class III
·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021