12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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R2 DIGITALNOW HD(DIGITALNOW HD)
FDA 510(k)
FDA Class 2
·Radiology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450672501·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450559901·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450639900·
DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER
FDA 510(k)
FDA Class 2
·General Hospital
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·January 9, 2014
GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·November 28, 2017
2520274-2013-02318
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·May 3, 2013
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 28, 2014
TRIDENT ACET WINDOW TRIAL 54MM
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·May 5, 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