23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COMPLETE BRAND MULTI-PURPOSE SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
COMPLETE
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code LPN·April 17, 2020
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00142021·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033571460·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033571439·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033571422·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033571415·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033571446·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033571453·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0112020·Tap, 4.75 mm
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0112020·Tap, 4.75mm
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0142080·Trial, TLIF, 32L OB CRV 7Deg, 8mm
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 28, 2014
MSI BIPOLAR SHEATH
FDA 510(k)
FDA Class 2
·Orthopedic
OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES
FDA 510(k)
FDA Class 2
·Neurology
PEN NDL 32G 4MM 100BX 1200 USA
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·January 20, 2021
PARIETEX UGYTEX PP POSTERIOR KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·March 12, 2013
TENDRIL STS
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011
ICY HOT HEAT THERAPY PATCH
FDA Adverse Event
Other
·CHATTEM, INC.·Product code IMD·March 13, 2008
ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, 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