11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELECSYS FOLATE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BONE FIXATION WIRE (KIRSCHNER WIRE)
FDA 510(k)
FDA Class 2
·Orthopedic
SDU-700 PHASED ARRAY SECTOR AND LINEAR SCANNER
FDA 510(k)
FDA Class 2
·Cardiovascular
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 19, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 18, 2011
12/14 ARTICUL 40MM M SPEC+1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·August 1, 2014
ENDOPATH ETS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·July 9, 1997
COULTER ACT PAK REAGENT KIT
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·September 24, 2014
COULTER ACT PAK REAGENT KIT
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·May 26, 2015
COULTER ACT PAK REAGENT KIT
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·May 5, 2015
Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·July 10, 2024