8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RACEGEL
FDA 510(k)
FDA Unclassified
·Unknown
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450572108·
AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P
FDA 510(k)
FDA Class 2
·Cardiovascular
BACTI-SWAB DRY
FDA 510(k)
FDA Class 1
·Microbiology
HALO360+ SIZING BALLOON
FDA Adverse Event
Injury
·COVIDIEN·Product code GEI·May 1, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 16, 2014
UNKNOWN DEPUY HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWY·May 12, 2011
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