16 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HOBBS MISTIFIER SPRAY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120307651·Diamond, cylinder round, medium grit
LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526
FDA 510(k)
FDA Class 2
·Hematology
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·January 5, 2016
AXIOM ICONOS R200
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE GMBH·Product code JAA·April 15, 2019
AXIOM ICONOS R200
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE GMBH·Product code JAA·April 11, 2019
TERUMO ADVACED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·March 27, 2013
FREQUENCY 55 TORIC (METHAFILCON B)
FDA Adverse Event
Injury
·COOPERVISION, INC.·Product code LPL·March 21, 2011
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·August 22, 2014
COULTER ISOTON III DILUENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GIF·May 1, 2014
COULTER ISOTON III DILUENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GIF·April 28, 2014
COULTER ISOTON III DILUENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GIF·March 27, 2014
AXIOM ICONOS R200
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE GMBH·Product code JAA·December 22, 2021
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·November 13, 2015
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