10 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HORIZON XVU
FDA 510(k)
FDA Class 2
·Cardiovascular
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450210789·
POLYMER COATED POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES
FDA 510(k)
FDA Class 2
·Physical Medicine
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·January 9, 2014
PM-8000 EXPRESS
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 16, 2014
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·April 20, 2011
VENTRALEX ST
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·March 24, 2023
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