15 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PHOSPHOLIN ES AND CALCIUM CHLORIDE
FDA 510(k)
FDA Class 2
·Hematology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033471·Baltic Denture System BDLoad BDLoad ↓ Ln6 PLSEu...
DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MAGNA TEK ESU-400
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 7, 2025
UNKNOWN MILLER GALANTE TIBIAL TRAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·January 30, 2018
UNKNOWN MILLER GALANTE BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·January 30, 2018
SENSIA SR
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NVZ·April 3, 2013
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·W. L. GORE & ASSOCIATES·Product code MIH·March 23, 2011
POLYFLUX LR CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIAYLZATOREN GMBH·Product code MSF·April 23, 2008
RUNWAY GUIDE CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·May 8, 2013
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDS·July 25, 2016
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDS·July 25, 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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024