11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDCOMP SUBCLAVIAN CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209131693·
C-INSIGHT
FDA 510(k)
FDA Class 2
·Radiology
POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
DUROM ACETABULAR COMPONENT
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·April 28, 2014
EXOSEAL VASCULAR CLOSURE DEVICE (VCD)
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code MGB·October 23, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code NBW·September 27, 2007
BIOLOX DELTA HIP SYSTEM MODULAR CERAMIC HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·December 21, 2017
G7 ACETABULAR SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·December 21, 2017
G7 ACETABULAR SYSTEM DUAL MOBILITY ACETABULAR LINER NEUTRAL 40MM D
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·October 28, 2016
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