43 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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C1 ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PED NIH™ Cardio-Marker
FDA UDI
MEDTRONIC, INC.·00613994964199·WVN CATH 990806 5PK 7F 125CM PED NIH
PED NIH™ Cardio-Marker
FDA UDI
MEDTRONIC, INC.·00763000200237·WVN CATH 990806 5PK 7F 125CM PED NIH
Flowart
FDA 510(k)
FDA Class 2
·General Hospital
SAFI-GEL DAILY DISPOSABLE (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, SAFI-GEL DAILY DISPOSABLE TORIC ( METHAFILCON
FDA 510(k)
FDA Class 2
·Ophthalmic
AETOS Shoulder System
FDA UDI
Smith & Nephew, Inc.·00885556811771·HUMERAL REAMER SIZE 5
AETOS Shoulder System
FDA UDI
Smith & Nephew, Inc.·00885556811733·HUMERAL REAMER SIZE 1
AETOS Shoulder System
FDA UDI
Smith & Nephew, Inc.·00885556811764·HUMERAL REAMER SIZE 4
AETOS Shoulder System
FDA UDI
Smith & Nephew, Inc.·00885556811757·HUMERAL REAMER SIZE 3
AETOS Shoulder System
FDA UDI
Smith & Nephew, Inc.·00885556811740·HUMERAL REAMER SIZE 2
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·June 13, 2018
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 28, 2018
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWQ·September 30, 2009
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code KWP·April 30, 2009
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·September 9, 2011
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWQ·January 14, 2009
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code KWQ·January 22, 2010
ATLANTIS® ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·July 12, 2017
ATLANTIS® ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·July 12, 2017
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·November 22, 2018