14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OMNI-TIGHT
FDA 510(k)
FDA Class 2
·Dental
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·June 7, 2018
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code JDS·February 13, 2017
CBS STRAW
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code KNS·March 15, 2019
HEARTSTART FR3 TEXT, BASIC BUNDLE, USENG
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 18, 2013
ADVIA 2120I
FDA Adverse Event
SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code GKL·April 29, 2011
ENTRUST AT
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·July 10, 2008
CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code KNS·February 4, 2019
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDS·July 5, 2016
CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code KNS·August 8, 2018
CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code KNS·August 8, 2019
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