11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LANDERS VITRECTOMY LENS RING W/INFUSION
FDA 510(k)
FDA Class 1
·Ophthalmic
N/A
FDA UDI
Smith & Nephew, Inc.·00885556076231·SMALL BLADE FOR INITIAL INCISION
...
TITAN PLUG SCREW 8MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA GMBH·Product code HSB·February 21, 2002
ANKLE ARTHRODESIS NAIL, LEFT 10X150MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 8, 2010
MODEL 4815 ADAPTER
FDA 510(k)
FDA Class 2
·Cardiovascular
COPRAN ZR/ORIGIN YZ
FDA 510(k)
FDA Class 2
·Dental
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·May 7, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·January 8, 2013
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIVISION·Product code FPO·November 12, 2010
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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