11 results · 23ms · Sources: EU EUDAMED, 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