10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACETABULAR CEMENT COMPRESSOR
FDA 510(k)
FDA Class 1
·Orthopedic
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515211476·Castro Corn Sci, mini blds
ORTHO SUMMIT SAMPLE HANDLER
FDA Adverse Event
Malfunction
·HAMILTON BONADUZ AG·Product code JTC·August 7, 1998
BLOOD SAMPLING SET
FDA 510(k)
FDA Class 2
·General Hospital
PALOMAR ASPIRE LASER PLATFORM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·May 9, 2014
HERCULES 3 STAGE BALLOON ESOPHAGEAL
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNQ·October 19, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 31, 2007
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
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018