96 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYSTEM COVERED BALE LOCK KNEE JOINT
FDA Adverse Event
Malfunction
·OTTO BOCK ORTHOPEDIC INDUSTRY, INC.·Product code ISW·June 19, 1998
UNKNOWN SCD
FDA Adverse Event
Other
·COVIDIEN·Product code JOW·November 24, 2010
UNKNOWN TEDS
FDA Adverse Event
Other
·COVIDIEN·Product code DWL·November 24, 2010
MEDRAD VERIS MRVITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·MEDRAD·Product code DQA·June 19, 2013
MEDRAD VERIS MR VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·MEDRAD·Product code MHX·June 6, 2013
MEDRAD VERIS MR VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·MEDRAD·Product code MHX·July 15, 2013
MEDRAD VERIS MR VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·BAYER MEDICAL CARE, INC.·Product code MWI·July 1, 2019
MEDRAD VERIS MR VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·MEDRAD·Product code MHX·April 19, 2013
MEDRAD VERIS MR VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·MEDRAD·Product code MHX·July 3, 2013
MEDRAD VERIS MR VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·BAYER MEDICAL CARE, INC.·Product code MWI·March 2, 2018
REX REHAB
FDA Adverse Event
Injury
·REX BIONICS LTD·Product code BXB·July 13, 2016
MEDRAD VERIS MR VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·BAYER MEDICAL CARE, INC.·Product code MWI·November 28, 2017
MEDRAD VERIS MR VITAL SIGNS MONITOR
FDA Adverse Event
Injury
·BAYER MEDICAL CARE INC.·Product code MHX·November 22, 2019
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·September 16, 2008
APD Disposable Sets and Extension Sets used with Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. The HomeChoice dialysis system is a personal cycler automated peritoneal dialysis system for pediatric and adult renal patients with fill volumes ranging from 60 mL to 3000 mL.
FDA Recall
Terminated
·Baxter Healthcare Renal Div·Product code FKX·March 16, 2011
Lower Limb Orthotics
FDA UDI
Boston Brace International, Inc.·00860013109851·
Lower Limb Orthotics
FDA UDI
Boston Brace International, Inc.·00860013109875·
ANKLE FOOT ORTHOSIS
FDA 510(k)
FDA Class 1
·Physical Medicine
Lower Limb Orthotics
FDA UDI
Boston Brace International, Inc.·00860013109882·
FOOT ORTHOTICS
FDA Adverse Event
Malfunction
·LANGER BIOMECHANICS·Product code KNP·November 28, 2015