15 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TRILOGY RADIOTHERAPY DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033343·Baltic Denture System BDLoad BDLoad ↓ Lm6 PLSEu...
DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE
FDA 510(k)
FDA Class 2
·Neurology
ENVIRON-NP DISPOSABLE SYNTHETIC VINYL EXAM GLOVES, POWDERED
FDA 510(k)
FDA Class 1
·General Hospital
D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·February 27, 2014
D903 DIDECO AVANT 2 VAVD PHISIO
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·February 19, 2014
IT PADOVA
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·August 8, 2013
D903 DIDECO AVANT VAVD PHISIO
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·August 16, 2013
TIBIAL COMPONENT PRECOAT RIGHT MEDIAL/LEFT LATERAL SIZE 3
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HSX·February 3, 2017
ASR UNI FEMORAL IMPL SIZE 43
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 3, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 25, 2014
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·March 22, 2011
C20441 IL HAIFA
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DWF·March 28, 2012
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