21 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450835951·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033582671·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033570845·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033570821·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033582695·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033570791·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033582688·
COMFOR-CLINER
FDA 510(k)
FDA Class 1
·Physical Medicine
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1,2,3,1, ML, LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 3 ML, LIQUICHEK IMMUNOLOGY CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PROLIFT +M PELVIC FLOOR REPAIR UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·May 2, 2018
ACCU-CHEK ® SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE AG·Product code LZG·March 21, 2013
QUICK FLEX LV LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·March 10, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·August 18, 2014
VACUETTE BLOOD COLLECTION TUBE 3ML K2E K2EDTA
FDA Adverse Event
Malfunction
·GREINER BIO-ONE NA INC.·Product code JKA·November 2, 2020
OT INDUO METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·March 30, 2011
OT INDUO METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·January 10, 2011
ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients
FDA Enforcement
Class II
·Terminated·Teleflex Medical·December 7, 2016
DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments.
FDA Enforcement
Class III
·Terminated·DeVilbiss Healthcare LLC·July 9, 2014
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