14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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JET-X HA COATED HALF PINS
FDA 510(k)
FDA Class 2
·Orthopedic
Safco D1amond
FDA UDI
SAFCO DENTAL SUPPLY CO.·10810063751002·Sterile Single Use Burs - ISO Code 605-018C
SunTech
FDA UDI
SUNTECH MEDICAL, INC.·10840935108931·
BD SYRINGE 20ML LL BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY·Product code FMF·January 16, 2024
DYRACT CEM LCI COMPOMER
FDA 510(k)
FDA Class 2
·Dental
PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES BETTLACH·Product code HWC·September 23, 2015
LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code LDD·March 27, 2013
ESPRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·March 18, 2011
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 4, 2008
APPLIANCE, FIXATION, NAIL
FDA Adverse Event
Injury
·SYNTHES USA·Product code KTT·August 18, 2015
APPLIANCE,FIXATION,NAIL
FDA Adverse Event
Injury
·SYNTHES BETTLACH·Product code KTT·October 10, 2016
PENUMBRA SMART COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·October 26, 2021
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