11 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MODEL MES-9000/EMG SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 4, 2024
UNK MAMMARY IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·April 14, 2020
STYLE 15 SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·April 14, 2020
DUR MAR 10D LINER 28IDX54OD
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 6, 2013
RELIANCE VISION SINGLE CHAMBER WASHER/DISINFECTOR
FDA Adverse Event
STERIS CANADA CORPORATION·Product code MEC·September 16, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 4, 2011
MIRU 1DAY UPSIDE (MIDAFILCON A)
FDA Adverse Event
Injury
·MENICON CO., LTD.·Product code LPL·January 22, 2025
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