10 results · 20ms · Sources: EU EUDAMED, US FDA

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MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS

FDA 510(k)
FDA Class 2 ·Radiology

DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS

FDA 510(k)
FDA Class 2 ·Orthopedic

ROUND FILTER POLYPROVPYLENE

FDA Adverse Event
Malfunction ·SPS MEDICAL SUPPLY CORP·Product code FRG·June 25, 2013

ABRAMS MULTIDENSITY POLYURETHAN FOAM WOUND DRESSING SYSTEM

FDA Adverse Event
Other ·DR LEN'S MEDICAL PRODUCTS·Product code FRO·October 11, 2005

3M TEGADERM ALGINATE AG SILVER DRESSING

FDA Adverse Event
Injury ·3M HEALTH CARE·Product code FRO·June 21, 2016

9600

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 4, 2011

7900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 26, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 16, 2014

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