29 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EAGLE EDGE AXR90 and AXR120
FDA 510(k)
FDA Class 2
·Radiology
GRYPHON PROKNOT PERMACORD
FDA UDI
Medos International Sàrl·10886705024025·GRYPHON BR Anchor w/PROKNOT Technology TCP/PLGA...
BMF FOOTSWITCH
FDA Adverse Event
Malfunction
·OSTEOMED, LLC·Product code GBB·November 16, 2021
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345023871·BAYONETTED STRAIGHT RING CURETTE
SOLUTION SYSTEM
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295086963·SOLUTION SYSTEM THINSHAFT REAMER 8mm DIA
MOBILE TROLLEY, UMT-200
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904085586·
GIRAFFE BLUE SPOT PT LITE
FDA 510(k)
FDA Class 2
·General Hospital
VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY
FDA Adverse Event
Injury
·DEPUY MITEK·Product code MAI·March 16, 2017
GRYPHON P BR DS ANCHOR W/ORTHOCORD
FDA Adverse Event
Injury
·DEPUY MITEK·Product code MAI·March 16, 2017
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·February 8, 2021
BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·February 16, 2021
GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code MAI·August 17, 2017
NAVLOCK
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code OLO·January 5, 2026
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code MMI·August 12, 2011
UNK
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code FPA·August 1, 2014
UNKNOWN DEPUY FEMORAL STEM
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·July 8, 2013
VITEK 2 Fungal Susceptibility card (AST-YS01), REF 22108, 20 cards per carton.
FDA Recall
Terminated
·Biomerieux Inc·Product code N/A·April 20, 2017
VITEK¿ 2 Fungal Susceptibility card (AST-YS01), REF 22108, 20 cards per carton.
FDA Enforcement
Class II
·Terminated·Biomerieux Inc·June 21, 2017
GRYPHON BR W/ PROKNOT
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code MAI·September 25, 2019