20 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09
FDA 510(k)
FDA Class 2
·Anesthesiology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032981·Baltic Denture System BDLoad ↓ Lw6 PLSEum4DFl C...
ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODEL LCSC5,LCSC1,CS23C,CS231,CS14C,CS141,LCSB5,LCSK5,LCS15,LCS16,CS150
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INION CPS 2.5/2.8 SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
ULTRACISION SURG DEV, CURVED SHEARS, OPEN
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code LFL·June 7, 2006
ULTRACISION SURG DEV, CURVED SHEARS, ENDO
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code LFL·June 7, 2006
ULTRACISION SURG DEV, CURVED SHEARS, ENDO
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code LFL·June 2, 2006
ULTRACISION SURG DEV, CURVED SHEARS, OPEN
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GEI·June 19, 2006
ULTRACISION SURG DEV, CURVED SHEARS, ENDO
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code LFL·June 19, 2006
ULTRACISION SURG DEV, CURVED SHEARS, ENDO
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code LFL·June 19, 2006
ULTRACISION SURG DEV, CURVED SHEARS, ENDO
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GEI·June 19, 2006
ULTRACISION SURG DEV, CURVED SHEARS, OPEN
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code LFL·June 7, 2006
ULTRACISION SURG DEV, CURVED SHEARS, ENDO
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GEI·June 19, 2006
EPIDURAL CATHETERIZATION KIT
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code CAZ·April 1, 2013
SPRINT FIDELIS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 29, 2011
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·August 25, 2014
SMARTNAIL
FDA Adverse Event
Injury
·CONMED CORPORATION·Product code MAI·July 29, 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
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
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013