10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET
FDA 510(k)
FDA Class 2
·General Hospital
Acapella One
FDA UDI
Choice Spine, LP·00840996150972·ACAPELLA,TRIAL,PA,NS,12X14X9
SLT LASERPRO CTH HOLMIUM LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER
FDA 510(k)
FDA Class 2
·Anesthesiology
EXTERNAL PADDLES
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 27, 2013
CRYSTALENS
FDA Adverse Event
Injury
·EYEONICS, INC.·Product code HQL·June 17, 2008
MULTI-LINK RX VISION CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code MAF·April 18, 2011
LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT
FDA Adverse Event
ROCHE MOLECULAR SYSTEMS·Product code OOI·July 11, 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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015