11 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO
FDA 510(k)
FDA Class 2
·Anesthesiology
IDI Dental Implant
FDA UDI
AIDI BIOMEDICAL LLC·D747IDI10431601·IDI Implant Fixture 4.3mm x 16.0mm
(Implant Pack)
IDI Dental Implant
FDA UDI
AIDI BIOMEDICAL LLC·D747IDI104316001·IDI Implant Fixture 4.3mm x 16.0mm
(Implant Only)
IDI Dental Implants
FDA UDI
AIDI BIOMEDICAL LLC·D747IDI1043160A1·IDI Implant Fixture 4.3mm x 16.0mm
(Practice Bu...
DRX5000
FDA 510(k)
FDA Class 2
·Physical Medicine
POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·April 9, 2013
SECURE 2 MED/SURGBED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·March 15, 2011
ENDOTAK RELIANCE G
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
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
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018